GutDrops Keto Drops: The Fat Burning Bariatric Seed Trick Ritual Using the Pumpkin Seed Asian Recipe by Dr. Clark
Doctor-Formulated GutDrops Keto Drops Ignite 2025 Weight Loss Buzz with the CSM Gut Bacteria Reset, Backed by the Fat Burning Bariatric Seed Trick Ritual and the Viral Pumpkin Seed Asian Recipe by Dr. Emma Clark
Chicago, May 13, 2025 (GLOBE NEWSWIRE) --
In This Article, You'll Discover:
What GutDrops Keto Drops are and why they are trending in 2025 for fast, effortless weight loss
How the Fat Burning Bariatric Seed Trick Ritual, using the Pumpkin Seed Asian Recipe by Dr. Emma Clark, works to support metabolism and reduce hunger
The powerful link between gut health, the microbiota balance, and your ability to burn fat without extreme dieting or exercise
Why thousands of users are turning to GutDrops for weight loss, body toning, and appetite control without significant lifestyle changes
A full breakdown of the GutDrops Keto Drops ingredients label, including phytosterols, grape seed extract, green tea extract, and vitamin D3
What genuine consumer reviews, testimonials, and Reddit users are saying about GutDrops Keto Drops results
How the GutDrops LeanTrack App supports a custom fat-burning protocol tailored to your body, age, and wellness goals
What to expect in terms of weight loss outcomes, satisfaction guarantees, and how to use GutDrops Keto Drops for best results
Transparent, up-to-date GutDrops pricing and available bundle packages with essential disclaimers about checking the official GutDrops website for the latest offers
Expert tips on how to incorporate GutDrops Keto Drops into your daily routine and why long-term use may promote consistent body transformation
TLDR: GutDrops Keto Drops Review Summary for 2025
GutDrops Keto Drops are a doctor-formulated weight loss supplement designed to work with your gut microbiota, using what's called the Fat Burning Bariatric Seed Trick Ritual. Based on the Pumpkin Seed Asian Recipe developed by Dr. Emma Clark, this drop-based formula is gaining massive traction in 2025 thanks to its potential ability to support fat burning, reduce hunger, and help users reshape their bodies naturally.
What sets GutDrops apart is its concentrated use of pumpkin seed extract, phytosterols, and other gut-friendly ingredients such as grape seed extract and green tea extract. These drops may help increase the presence of CSM-type fat-burning bacteria in the gut, which is believed to aid metabolism and energy conversion, especially in individuals struggling with bloating, low energy, and stubborn fat areas.
Early reviews and GutDrops Keto Drops testimonials suggest significant results in as little as 28 days, with some users reporting reductions in belly fat, appetite suppression, and improved digestion. However, individual results may vary, and this is not a substitute for professional medical advice. GutDrops is best used as part of a longer-term wellness strategy, and for optimal results, users are encouraged to follow the product's recommended use for 3, 6, or 12 months.
GutDrops Keto Drops pricing ranges depending on the treatment length. Always check the official GutDrops website for current offers and package availability, as pricing is subject to change at any time.
Whether you're searching for GutDrops Keto Drops reviews, curious about the Pumpkin Seed Asian Recipe, or looking for a proven alternative to traditional dieting, this article breaks down everything you need to know to decide if GutDrops Keto Drops is the right formula for your 2025 weight loss journey.
Why GutDrops is America's #1 Drop Supplement in 2025
In a world saturated with diet fads, complex workout plans, and overpriced pills, millions of health-conscious consumers are asking the same question: Is there a more straightforward way to lose weight in 2025? According to a growing number of users across the country—and an increasing buzz across Reddit, forums, and social media—GutDrops Keto Drops may be the answer.
What makes GutDrops stand out isn't just the sleek bottle or its celebrity endorsements. It's the unique science behind its formulation—what some are now calling the Fat Burning Bariatric Seed Trick Ritual, developed by functional weight loss expert Dr. Emma Clark. The ritual centers around an ancient yet overlooked metabolic food: the pumpkin seed. When properly extracted and paired with just the right support ingredients, it may help support digestion, control hunger, and trigger a metabolic process many find difficult to achieve with diet and exercise alone.
For those frustrated with stubborn belly fat, low energy, and failed dieting cycles, GutDrops Keto Drops offers a new path—one that doesn't involve starving, counting calories, or sacrificing foods you love.
What's Driving the Buzz Behind GutDrops in 2025?
At the core of the GutDrops formula is a high-potency, fast-absorbing extract of phytosterol-rich pumpkin seed, inspired by what has come to be known as the Pumpkin Seed Asian Recipe. Backed by emerging gut health research, this drop-based system focuses on rebalancing the body's gut microbiota and may help increase levels of beneficial CSM-type fat-burning bacteria. Supporters of the formula point to studies suggesting that an optimized gut may significantly influence fat metabolism, appetite, and energy conversion, especially as we age.
GutDrops rapidly climbed to the top of natural weight loss searches in 2025, with keywords like "GutDrops Keto Drops reviews,""GutDrops Keto Drops ingredients label," and "Gut Drops for weight loss" trending across Google. The testimonials pouring in from women and men alike paint a consistent picture: rapid improvements in how they feel, how they look, and how they approach wellness overall.
What You'll Gain From This Article
If you're serious about reclaiming your health and dropping weight naturally without gimmicks, you're in the right place. This article will give you a complete breakdown of:
What GutDrops Keto Drops really are—and how they work
Why the Fat Burning Bariatric Seed Trick Ritual is becoming the go-to alternative to traditional weight loss
A deep dive into the Pumpkin Seed Asian Recipe by Dr. Emma Clark, and why it's gaining recognition worldwide
How to safely use GutDrops, what's inside the bottle, and how the formula fits into your everyday routine
Genuine GutDrops Keto Drops reviews, consumer testimonials, and Reddit buzz from everyday users and influencers
A complete pricing and package breakdown—with a clear disclaimer to always verify current prices directly on the official GutDrops Keto Drops website, as prices may change at any time
Whether you're exploring GutDrops Keto Drops reviews and complaints, trying to understand the ingredients label, or curious about whether this bariatric seed ritual could finally solve your weight loss struggles, this article will walk you through everything, step by step.What Are GutDrops Keto Drops?
In a wellness market crowded with trendy gummies, powders, and pills, GutDrops Keto Drops have emerged as a standout liquid supplement in 2025. But what exactly are they, and why are thousands of people replacing their traditional weight loss supplements with this drop-based formula?
Unlike most over-the-counter solutions that focus only on calorie control or stimulant-based fat burning, GutDrops approaches weight management from a microbiome-first perspective. This formula was designed to help rebalance the gut by increasing levels of CSM-type fat-burning bacteria. This strain has recently been studied for its potential connection to reduced fat storage, better metabolism, and appetite regulation.
When searching for GutDrops Keto Drops, it is often referred to by its full name. It has gained popularity thanks to the unique way it activates what's now being called the Fat Burning Bariatric Seed Trick Ritual—a simple method based on the Pumpkin Seed Asian Recipe developed by Dr. Emma Clark.
A New Generation of Weight Management Supplement
What makes GutDrops different from most fat burners or keto diet aids?
High Bioavailability in Liquid Drop Form
GutDrops are delivered as liquid drops and designed for sublingual absorption before meals. This method is said to improve absorption rates by up to four times compared to capsules or gummies. As a result, users may experience the benefits of the ingredients more quickly and efficiently.
Disclaimer: Results may vary from person to person. GutDrops is not intended to diagnose, treat, cure, or prevent any disease.
Doctor-Formulated with Natural Extracts
Each drop contains a precisely formulated blend of natural compounds, including:
Pumpkin seed extract (rich in phytosterols)
Grape seed extract
Green tea extract
Vitamin D3
This combination is designed to target gut health, support hunger suppression, and help the body restore metabolic balance from within.
Personalized Supplementation Protocol
GutDrops Keto Drops offers more than a one-size-fits-all formula. When ordering from the official website, customers complete a short intake form covering age, weight, height, and personal weight loss goals. This data is used to recommend a custom dosage strategy, setting GutDrops apart from generic supplements.
No Need for Restrictive Diets or Intense Workouts
One of GutDrops' core appeals is its simplicity. According to the creators, all it takes is 2 drops before each meal—no additional calorie counting, restrictive food lists, or intense training programs are required.
Disclaimer: For best results, users are encouraged to maintain a healthy routine and consult a licensed healthcare provider before beginning any supplement.Why the Name "GutDrops"?
The name reflects the formula's core goal: supporting gut health. The link between gut microbiota and metabolism is increasingly backed by emerging research. Specifically, GutDrops aims to:
Reduce harmful gut bacteria linked to bloating, sugar cravings, and fat accumulation
Increase Christensenella minuta (CSM), a strain studied for its fat-regulating properties
Support metabolic health, hormonal balance, and energy regulation through a healthy digestive system
The Buzz Behind the Name: GutDrops, Gut Drops, and GutDrops Keto Drops
Online, users search for this product under various names, including:
GutDrops Keto Drops
GutDrops reviews
Gut Drops for weight loss
GutDrops Emma Clark
GutDrops Keto Drops website
GutDrops Keto Drops reviews Reddit
This surge in search traffic is a clear indicator of rising interest, and many are turning to this product as a complement or replacement to pills, injections, and low-carb crash diets.
The Science Behind Gut Health and Weight Loss
The connection between gut health and weight management has gained massive attention in recent years, and in 2025, it's now seen as a cornerstone of any sustainable fat loss approach. GutDrops Keto Drops leverages this science, not by relying on stimulants or appetite suppressants, but by targeting the microbiota—the complex ecosystem of bacteria inside your digestive tract that plays a vital role in how your body processes food, stores fat, and signals hunger.
At the center of this approach is a unique strain of beneficial bacteria called Christensenella minuta, commonly abbreviated as CSM. Recent studies suggest that individuals with high levels of CSM tend to be leaner, more metabolically active, and less prone to stubborn fat accumulation. Although research is still ongoing, the GutDrops formula was designed to support this exact bacterial strain using a specific combination of nutrients and extracts.
Disclaimer: While preliminary research on CSM bacteria is promising, GutDrops is not a medical treatment, and results may vary. Always consult a healthcare provider for individualized medical advice.
How Gut Bacteria Influence Your Weight
Gut bacteria help determine whether the calories you consume are stored as fat or burned for energy. This process, often referred to as caloric partitioning, is now believed to be heavily influenced by the composition of your gut microbiota. When this balance is off, it can lead to:
Slower metabolism
Increased cravings
Higher fat storage, especially in the belly and thigh areas
Chronic fatigue and low energy
By supporting the gut's natural ecosystem, GutDrops Keto Drops may assist the body in optimizing these internal processes, making it easier to shed fat and maintain energy levels throughout the day.
What Causes Gut Imbalance?
Many people struggling with weight gain have unknowingly damaged their gut health over time. Contributing factors include:
Ultra-processed foods
Preservatives and artificial additives
Environmental toxins and pollutants
Chronic stress and poor sleep habits
Antibiotic overuse or digestive issues
These elements can wipe out beneficial gut bacteria like CSM and allow harmful microbes to thrive, leading to digestive discomfort, bloat, and weight retention.
Why GutDrops Targets the Microbiota First
The creators of GutDrops Keto Drops chose a gut-first formula based on studies that linked CSM bacteria levels with lean body mass and low fat storage. Their goal was to design a natural supplement that could help:
Rebuild healthy bacterial colonies
Increase the population of fat-burning CSM strains
Restore balance to the microbiota
Improve digestion and nutrient absorption
Enhance feelings of satiety without harsh appetite suppressants
Disclaimer: Gut health influences vary by individual. GutDrops is not a substitute for prescribed probiotics or medical-grade digestive treatments.
The Gut-Fat Connection and Weight Gain After 40
One of the key concerns addressed by GutDrops is age-related weight gain. As people get older, their microbiota diversity tends to decline. This drop in diversity is now linked to:
Sluggish metabolism
Reduced insulin sensitivity
Increased inflammation
Hormonal imbalances affecting fat distribution
By helping to reintroduce beneficial strains like CSM and supporting gut function, GutDrops aims to help individuals over 40 manage their weight more effectively, without depending on drastic dietary changes or exhausting workouts.The Fat-Burning Bariatric Seed Trick Ritual Explained
One of the most talked-about weight loss breakthroughs of the last two years is what's being referred to as the . This simple, natural recipe has exploded in popularity across social media, Hollywood circles, and functional wellness communities. Central to this ritual is a small, familiar ingredient hiding in most kitchen pantries: the pumpkin seed.
Popularized by Dr. Emma Clark, a researcher and author of the best-selling book Fat Burning Secrets, this ritual forms the philosophical and nutritional foundation behind GutDrops Keto Drops. Dr. Clark's method involves preparing the seed in a specific way—combining it with two additional natural ingredients to activate its gut-cleansing and metabolism-supporting properties.
Where Did the Ritual Originate?
While pumpkin seeds have long been used in Eastern medicine and traditional herbal formulas, the recent rise of the Pumpkin Seed Asian Recipe stems from Dr. Clark's exploration into why specific populations remain naturally slim despite high-calorie diets. Her investigations led to the discovery of how certain nutrient-dense seeds, when activated correctly, could help rebalance the gut and potentially support weight loss.
According to Dr. Clark, the magic lies not just in the seed itself, but in how it's prepared and consumed, particularly on an empty stomach, with warm water, and in a liquid-activated form.
Disclaimer: The Fat-Burning Bariatric Seed Trick Ritual is based on traditional and anecdotal wellness practices. It is not a substitute for professional dietary guidance.
The Bariatric Seed and Its Unique Gut Effects
Dubbed the "bariatric seed" by researchers and media alike, pumpkin seeds stand out because of their high content of phytosterols—plant compounds that may influence gut health, metabolic activity, and energy regulation. Research referenced by the GutDrops development team suggests that when consumed in optimal concentration, phytosterols may support the proliferation of CSM-type fat-burning bacteria in the gut.
This bacterium is believed to play a critical role in:
Reducing how much of your food is stored as fat
Converting more calories into clean-burning energy
Naturally regulating hunger hormones such as leptin
Supporting improved digestion and waste elimination
While eating raw pumpkin seeds may offer some benefits, studies indicate that the amount needed daily to impact CSM levels would require consuming hundreds of seeds per day. That's why the development of GutDrops Keto Drops was so significant—it delivers the active compounds of the ritual in a potent, easily absorbed liquid form.
Celebrity Adoption and the Viral Surge of 2023–2024
In 2023, several Hollywood actresses preparing for major roles began crediting this seed ritual for their rapid body transformations. Social media buzz soon followed, as videos showcasing weight loss testimonials tied to the ritual gained millions of views. These stories fueled a surge in searches for:
Fat-Burning Bariatric Seed Trick Ritual
Pumpkin Seed Asian Recipe for Weight Loss
GutDrops Keto Drops reviews and complaints
Gut Drops Emma Clark
Many of these women reported noticeable weight loss in less than 30 days, particularly around problem areas like the belly, thighs, and upper arms. While results vary based on age, lifestyle, and adherence, the ritual's appeal remains in its simplicity and accessibility.
Disclaimer: Individual results are not guaranteed. Always consult a qualified health professional before starting any new supplement or ritual.Exploring the Pumpkin Seed Asian Recipe by Dr. Emma Clark
At the heart of the GutDrops Keto Drops formula lies a centuries-old secret, modernized for today's wellness world: the Pumpkin Seed Asian Recipe. Developed and popularized by Dr. Emma Clark, this unique recipe is the foundation of what has become known as the Fat Burning Bariatric Seed Trick Ritual—a natural method focused on rebalancing gut bacteria to support fat metabolism, energy levels, and appetite control.
But what exactly is this recipe? And why is it being embraced by thousands of women and men around the world, many of whom claim to have dropped 20 to 30 pounds in under 30 days?
Disclaimer: The Pumpkin Seed Asian Recipe is a wellness-focused approach rooted in natural ingredient combinations. It is not a cure, treatment, or medical protocol.
What is the Pumpkin Seed Asian Recipe?
The recipe itself is deceptively simple. It revolves around the warm water activation of pumpkin seeds combined with two other secret pantry ingredients, formulated in precise ratios to maximize absorption and metabolic effects. This method, when performed consistently, is believed to support the production of CSM-type bacteria in the gut, a strain increasingly studied for its connection to body composition and fat storage regulation.
According to anecdotal evidence and early studies referenced in the GutDrops Keto Drops promotional materials, this ritual:
It may help reduce hunger signals within the first 24 hours
Supports digestive regularity and gut microbiota balance
May contribute to reduced cravings for sugar and processed foods
Could result in visible inch loss and improved body definition over time
Dr. Clark herself has shared that she lost over 25 pounds in just four weeks using this ritual, without going to the gym or giving up her favorite foods.
Why Pumpkin Seeds?
Pumpkin seeds are rich in:
Phytosterols: Plant compounds associated with healthy cholesterol and blood sugar balance
Magnesium and Zinc: Minerals critical for metabolism and hormonal balance
Antioxidants: Supporting inflammation control and digestive resilience
Protein and Fiber: Key nutrients for satiety and sustained energy
Recent research suggests that pumpkin seed compounds may help nourish the digestive lining, support the immune system, and create a gut environment favorable to beneficial bacteria such as Christensenella minuta (CSM).
Disclaimer: While pumpkin seeds are nutrient-dense, consuming them alone in raw form is unlikely to deliver the concentrated effects of properly extracted phytosterols as used in GutDrops Keto Drops.
How GutDrops Simplifies the Ritual
Dr. Clark partnered with Wellness Prime Laboratories to distill this complex preparation process into a single product. Through advanced extraction techniques, GutDrops delivers a concentrated form of pumpkin seed phytosterols alongside other synergistic ingredients, making it easy to follow the ritual without cooking, measuring, or sourcing exotic ingredients.
Instead of daily tea preparations or overnight seed soaking, users take 2 drops of GutDrops before each meal, activating the same principles of the ritual in a modern, accessible way.
This has made the Pumpkin Seed Asian Recipe more than just a wellness trend—it's become a cornerstone of modern microbiome-based weight management strategies, and a significant reason why terms like:
GutDrops Keto Drops ingredients label
Pumpkin Seed Asian Recipe for fat burning
Fat-Burning Bariatric Seed Trick Ritual
They are trending heavily in search in 2025.Key Ingredients in GutDrops Keto Drops
The power of GutDrops Keto Drops lies in its carefully selected, doctor-formulated blend of natural ingredients. Each component is chosen for its unique role in supporting gut balance, metabolic function, and fat processing—all without requiring users to overhaul their diets or routines.
In this section, we'll break down the ingredients found on the GutDrops Keto Drops ingredients label and explore how each one may contribute to the supplement's gut-health-first approach.
Disclaimer: The information below is for educational purposes only and not intended to diagnose, treat, or prevent any disease. Always consult your healthcare provider before beginning any new supplement.
Pumpkin Seed Extract (Phytosterol-Rich Bariatric Seed)
This is the core ingredient behind the Pumpkin Seed Asian Recipe and the Fat-Burning Bariatric Seed Trick Ritual developed by Dr. Emma Clark. Through an advanced extraction process, this ingredient provides high concentrations of phytosterols—plant-based compounds that may support gut microbiota diversity, particularly the proliferation of CSM-type fat-burning bacteria.
Pumpkin seed extract in this formula is:
Designed to help support metabolism and energy conversion
Associated with reduced hunger and improved satiety
Linked in early research to gut balance and lower visceral fat retention
Note: While raw pumpkin seeds are healthy, the concentrated extract used in GutDrops delivers a level of phytosterols that would be impractical to consume through diet alone.
Grape Seed Extract
Rich in oligomeric proanthocyanidins (OPCs), grape seed extract is known for its antioxidant and detoxification potential. It may help:
Neutralize free radicals and reduce cellular oxidative stress
Support skin elasticity and promote a youthful appearance during weight loss
Encourage lymphatic and digestive function by helping flush toxins
In the context of GutDrops, this ingredient complements the gut-cleansing properties of pumpkin seed extract and may aid in maintaining clear skin, improved circulation, and reduced water retention.
Green Tea Extract
A staple in many natural fat-loss protocols, green tea extract is included in GutDrops for both its metabolic and neuro-supportive roles. It contains:
Catechins, especially EGCG, which may help promote fat oxidation
Natural compounds linked to leptin production and hunger regulation
Potential benefits to mood and energy via dopamine and serotonin support
When paired with GutDrops' microbiota-boosting action, green tea extract may enhance overall fat-burning synergy, especially when taken before meals.
Disclaimer: Green tea extract offers general wellness support and is not intended to function as a stimulant-based fat burner.
Vitamin D3
Often overlooked in weight loss formulas, Vitamin D3 plays a critical role in immune health, metabolic regulation, and cellular communication. Emerging studies have shown that low vitamin D levels may correlate with higher fat storage, poor insulin sensitivity, and lower energy levels.
In GutDrops, Vitamin D3 supports:
Immune resilience during weight loss
Muscular and bone health
Mental focus, clarity, and energy stability throughout the day
Vitamin D3 is especially important for women over 40 who may experience hormonal shifts or slower recovery during fat loss phases.
Why This Combination Matters
GutDrops isn't just a collection of trendy extracts. Its formula is rooted in gut-centric fat burning, which targets the root of many weight management issues—imbalanced gut bacteria. By using a liquid format for better absorption and combining the above nutrients into a single formula, GutDrops aims to simplify wellness without sacrificing efficacy.
Users often report early changes in digestion, hunger patterns, and bloating before more noticeable shifts in weight or inches. This aligns with the supplement's focus on repairing gut health first and then unlocking metabolic improvements.
Search interest continues to grow for related phrases like:
GutDrops Keto Drops reviews and complaints
GutDrops Keto Drops consumer reports
Gut Drops for weight loss
This demand reflects a growing curiosity among consumers about what's actually in the formula. Now, you have a clear understanding of how each ingredient plays its part.How to Use GutDrops for Optimal Results
One of the most appealing aspects of GutDrops Keto Drops is how easy they are to use. Unlike traditional supplements that require multiple pills a day, complex schedules, or restrictive food protocols, GutDrops were created with real life in mind—simple, quick, and designed to work with your body's natural rhythms.
Understanding how and when to use GutDrops is essential if you want to maximize your results.
Daily Use Instructions
The recommended protocol is straightforward:
Take 2 drops of GutDrops Keto Drops
Place directly under your tongue
Do this 30 minutes before each meal — ideally breakfast, lunch, and dinner
This sublingual method allows the body to begin absorbing the active ingredients immediately, bypassing some digestive barriers that may reduce the effectiveness of capsules or powders.
Disclaimer: Always follow the usage instructions on the product label and consult with your healthcare provider before starting any new supplement routine.
No Refrigeration or Preparation Required
GutDrops is shelf-stable and does not require refrigeration. The drops come in a sealed bottle that protects the formula from heat, light, and oxygen degradation, making it ideal for:
Travel
Daily commuting
Workplace use
Weekend getaways or vacation routines
This convenience is one reason GutDrops Keto Drops reviews often highlight ease of use as a top benefit.
Expected Timeline of Benefits
While individual experiences may vary, most users report the following general timeline:
Days 1–5
Digestive relief and reduced bloating
Decreased sugar cravings
Improved regularity and energy
Week 2–4
Noticeable reduction in appetite
Fat loss in common problem areas (belly, thighs, upper arms)
Clothing fits more loosely; improved skin texture
Month 2+
Sustained weight reduction
Higher metabolic energy throughout the day
Mood improvement, confidence boost, better sleep patterns
Visible body reshaping, especially with consistent use
Disclaimer: Results vary depending on factors such as age, weight, metabolism, and dietary habits. GutDrops is not a guaranteed weight loss product and should be used as part of an overall wellness strategy.
Consistency is Key
The creators of GutDrops emphasize the importance of maintaining consistent use, especially during the first 90 to 180 days. This period is considered critical for fully rebalancing the gut microbiota and supporting the development of CSM-type fat-burning bacteria. Those who commit to 3, 6, or even 12 months of use typically experience more sustainable transformations.
Users also frequently ask how long they should take the product. While GutDrops begins working from day one, extended use has been associated with:
More stable weight maintenance
Enhanced skin firmness and reduced sagging
Long-term improvements in gut and immune health
Paired with the LeanTrack App
All GutDrops customers who purchase a multi-month supply receive free access to the LeanTrack App, a custom health companion that:
Tracks weight, mood, digestion, and energy
Offers personalized meal and activity suggestions
Helps users stay accountable and see measurable progress
This integrated approach ensures users get the full benefit of their GutDrops Keto Drops treatment plan—and keeps them on track without relying on willpower alone.Real User Experiences and Testimonials
No marketing message speaks louder than the voices of real people. As GutDrops Keto Drops continue to rise in popularity across the United States and beyond, thousands of users are sharing their transformative stories—many of them women and men who had tried everything before discovering what they now call the Fat-Burning Bariatric Seed Trick Ritual.
From everyday moms to busy professionals to older adults with slowed metabolisms, GutDrops has struck a chord with those who want to lose weight naturally without feeling deprived or drained. While individual results vary, the volume of testimonials, reviews, and discussions on forums like Reddit suggests a growing movement around this gut-focused formula.
Disclaimer: These are individual user experiences and do not guarantee specific results. Weight loss outcomes will vary based on personal factors and consistency of use.
Before-and-After Testimonials
Victoria – Age 34
"After having my second child, I couldn't lose the weight no matter how healthy I ate. I tried GutDrops after seeing an ad about the Pumpkin Seed Asian Recipe. I honestly didn't expect much—but after 3 weeks, I'd lost 18 pounds, and I felt lighter, less bloated, and finally like myself again."
Ashley – Chicago, IL – Age 42
"This ritual works. I used GutDrops consistently for six weeks. I didn't diet, I didn't count calories, and I still dropped 37 pounds. Even better? My energy is back, my cravings are gone, and I've stopped obsessing over food."
Eva – Age 61
"Nothing else worked for me. At my age, everything slows down. But after using GutDrops Keto Drops every day for a month, I was down 30 pounds. My skin looks better, my stomach is flatter, and I'm finally not at war with my body."
What People Are Saying Online
Searches for terms like GutDrops Keto Drops reviews Reddit, GutDrops Keto Drops consumer reports, and GutDrops reviews and complaints continue to grow. What stands out most across these platforms is consistency—users frequently highlight the simplicity, rapid results, and side benefits of improved digestion, skin, and mood.
Here's a summary of common feedback points seen across testimonials:
"Reduced belly bloat within 72 hours."
"Clothes fitting looser in under two weeks"
"No more late-night cravings"
"Natural appetite control without stimulants"
"Skin looks clearer and firmer after month one."
"Way more energy by the second week"
"This is the only thing that worked after menopause."
Even among those who were initially skeptical, a common theme emerges: GutDrops Keto Drops offer a refreshing change from the disappointment of fad diets, one-size-fits-all supplements, and false promises.
Why These Results Are Different
Unlike other weight loss solutions that rely heavily on caffeine, laxatives, or extreme calorie restriction, GutDrops supports internal balance through the microbiome. By promoting the growth of fat-burning CSM bacteria and restoring gut health, the drops may help the body do what it was designed to do—burn fat efficiently and naturally.
That's why users often describe GutDrops as something that "resets" their systems, finally allowing their bodies to respond the way they should have all along.
Reminder: For best results, GutDrops should be used consistently as directed, and users are encouraged to pair usage with realistic wellness habits when possible.Pricing, Packages, and Money-Back Guarantee
If you've been considering trying GutDrops Keto Drops, one of the most important things to understand is the value built into its pricing structure. Unlike other weight loss products that lock users into expensive monthly subscriptions or rely on hidden fees, GutDrops is offered in transparent, straightforward packages with tiered pricing based on your commitment level.
This section breaks down what's available, what each option includes, and the generous guarantee that removes any risk from trying GutDrops for yourself.
Disclaimer: All prices are accurate at the time of writing, but may change without notice. Always check the official GutDrops website for the most up-to-date pricing, availability, and promotions.
Available Package Options
GutDrops is currently available in three core packages:
60-Day Supply (2 Bottles)
Price: $79 per bottle
Ideal for users who want to test short-term gut support
No bonus gifts included
90-Day Supply (3 Bottles)
Price: $69 per bottle
Buy 2, Get 1 Free
Includes free shipping
Comes with 3 bonus gifts:
Stretch Mark Eraser Guide ($49 value)
Lifted Butt and Toned Thighs Masterclass ($79 value)
No More Varicose Veins Ebook ($39 value)
180-Day Supply (6 Bottles – Best Value)
Price: $49 per bottle
Buy 3, Get 3 Free
Free shipping included
Includes all 3 bonus gifts
Priority delivery and access to the LeanTrack App
These packages are designed to encourage users to complete a minimum of 90 to 180 days of treatment, which is the typical time it takes to rebalance the gut microbiota and fully maintain long-term fat-burning results.
How to Purchase
GutDrops is only available through the official website. It is not sold in pharmacies, retail stores, Amazon, or third-party platforms to ensure:
Product authenticity
Maximum freshness and ingredient potency
Protection from counterfeit formulas
Purchases are securely processed using encrypted checkout, and orders are shipped within 24–48 hours in discreet packaging for customer privacy.
Note: Some discounts, such as "Buy 3, Get 3 Free," are part of the limited-time Zero Obesity Campaign and may not be available after the current inventory runs out.
180-Day Satisfaction Guarantee
A 180-day 100% money-back guarantee protects every order of GutDrops Keto Drops. This means you can try the product risk-free for six months and, if you're not completely satisfied with your results, request a full refund.
How the guarantee works:
No hidden conditions
No requirement to return used or unused bottles
Email-based refund request process
You keep your bottles and bonus materials, even if you get your money back
Disclaimer: Guarantee applies only to purchases made through the official GutDrops Keto Drops website and must be claimed within 180 days of the delivery date.
Why Long-Term Supply Plans Are Recommended
The science behind GutDrops emphasizes consistency, particularly during the critical early phase when your gut microbiota is being rebalanced. The longer the treatment, the more support your system receives to:
Restore beneficial CSM-type bacteria
Maintain reduced hunger and improved digestion
Support skin elasticity and energy regulation during fat loss
For this reason, most GutDrops reviews recommend choosing a 3-month or 6-month plan. Not only does this reduce the cost per bottle, but it also prevents gaps in treatment due to out-of-stock issues that occasionally arise due to demand spikes.Addressing Common Questions and Concerns
It's natural to have questions before adding any new supplement to your daily routine. Many readers researching GutDrops Keto Drops reviews, ingredients, or usage instructions are seeking clarity about what to expect, how the formula works, and whether it's genuinely different from other weight loss products on the market.
Below are the most common questions consumers ask, answered in detail to help you make a confident and informed decision.
Is GutDrops safe to use for everyone?
GutDrops Keto Drops are formulated using natural, non-GMO ingredients, and are free from gluten, soy, dairy, and artificial additives. The formula was developed under doctor supervision and manufactured in a facility that adheres to GMP (Good Manufacturing Practices) standards.
Disclaimer: While the ingredients in GutDrops are generally recognized as safe, individuals who are pregnant, nursing, under 18, or have a medical condition should consult their physician before using.
How is this different from other weight loss supplements?
Most supplements focus only on calorie restriction, thermogenesis, or blocking carbohydrates. GutDrops, on the other hand, targets the root cause of many weight struggles: imbalanced gut microbiota. By supporting the growth of CSM-type fat-burning bacteria, GutDrops may help your body naturally shift into a more efficient metabolic state, without the use of stimulants, crash dieting, or intense exercise routines.
This gut-first approach has made phrases like "GutDrops Keto Drops reviews Reddit" and "Gut Drops for weight loss" some of the fastest-rising queries in the wellness space.
Can I take GutDrops alongside other supplements or medications?
There are currently no known adverse interactions between GutDrops and most supplements or medications. That said, because GutDrops is designed to support digestion, metabolism, and internal balance, it's best to consult a healthcare provider before combining with other treatments, especially those related to digestion, insulin regulation, or hormonal therapy.
Will I need to diet or exercise for it to work?
While no product is a replacement for a healthy lifestyle, GutDrops is designed for real-world use. That means you can continue eating normally while taking the product. However, many users report natural appetite suppression, reduced cravings, and an easier time making healthier choices once they begin using the drops.
Disclaimer: GutDrops is not a substitute for a balanced diet or professional fitness plan, but it may help users achieve their goals more comfortably and consistently.
What if I don't see results right away?
Fat loss timelines vary based on age, weight, metabolic condition, and consistency of use. Most users begin to see digestive improvements within the first 5 days, followed by appetite control and visible weight loss within 2–4 weeks.
Those who use GutDrops Keto Drops for at least 90–180 days typically report the most substantial and lasting changes, including:
Inches lost from the waist, hips, and thighs
Reduced sugar cravings and snacking
Improved energy and digestion
Flatter, firmer stomach and enhanced skin tone
Can men use GutDrops too?
Absolutely. While many of the testimonials highlight women's experiences, the formula is effective for all adults, regardless of gender. The gut-focused strategy applies to everyone looking to improve metabolism, digestion, and fat regulation.
Why isn't GutDrops sold in stores or pharmacies?
To maintain formula integrity, avoid third-party tampering, and ensure personalized dosage recommendations, GutDrops Keto Drops are sold exclusively through the official website. This direct-to-consumer model also keeps prices more affordable by eliminating retail markups and ensures every bottle is made to current lab specifications.Conclusion – Embrace a Healthier You with GutDrops
If you've made it this far, you now have a clear, research-backed understanding of how GutDrops Keto Drops stand apart from every other weight loss product on the market. You've discovered how this doctor-formulated liquid drop taps into a simple, natural method—the Fat Burning Bariatric Seed Trick Ritual—using the now-viral Pumpkin Seed Asian Recipe by Dr. Emma Clark.
While most people are chasing short-term fixes, GutDrops offers something much more powerful: a long-term solution rooted in gut health and internal balance. Instead of chasing endless fad diets or harsh pills, this approach works with your body by supporting the growth of CSM-type fat-burning bacteria that may help your metabolism function the way nature intended.
You've also learned:
Why are thousands turning to GutDrops Keto Drops reviews across Reddit and other forums for real, relatable results?
How GutDrops may support natural fat metabolism, hunger reduction, energy improvement, and digestive resilience
What makes this formula different, and how it simplifies the Pumpkin Seed Asian Recipe into just 2 drops before each meal
What the ingredients—like pumpkin seed extract, green tea extract, and grape seed extract—can do when working together in liquid synergy
How to safely and effectively use GutDrops as part of a 60, 90, or 180-day wellness plan
How the pricing works, and what to expect when you order from the official GutDrops Keto Drops website
The truth is, your struggle isn't about lack of discipline, willpower, or effort. The modern world, filled with gut-disrupting toxins, ultra-processed foods, and chemical-laden meals, has made weight gain a battle stacked against you.
But with GutDrops, you now have an opportunity to reset that foundation and experience what's possible when your metabolism starts working with you, not against you.
Take the First Step Today
Whether you're here because you're tired of dieting, discouraged by plateaued results, or ready to try something that actually aligns with your body's biology, GutDrops could be the turning point.
Thousands have already started their transformation.
You can start yours today.
Disclaimer: For current pricing, available bundles, and guaranteed delivery, always refer to the official GutDrops website. Prices and availability may change at any time.
TLDR: GutDrops Keto Drops Review Summary
GutDrops Keto Drops is a liquid weight loss supplement designed to support the gut microbiota, promote fat metabolism, and help reduce stubborn weight by using the Fat Burning Bariatric Seed Trick Ritual. The formula is based on Dr. Emma Clark's Pumpkin Seed Asian Recipe, delivering high-potency phytosterols in a fast-absorbing drop format.
Users are instructed to take just 2 drops before each meal, which may help regulate appetite, reduce bloating, support gut health, and increase the presence of beneficial CSM-type fat-burning bacteria. This gut-first strategy is what separates GutDrops from traditional calorie-restriction or stimulant-based fat burners.
Testimonials highlight significant changes in energy, waist size, mood, digestion, and overall confidence, with many reporting 20 to 30 pounds lost in as little as 4 weeks. While individual results vary, the formula is backed by a 180-day money-back guarantee and comes in multiple treatment plans for 60, 90, or 180 days.
GutDrops is trending across platforms like Reddit and Google, with search demand spiking for:
GutDrops Keto Drops reviews
GutDrops ingredients label
Gut Drops for weight loss
Pumpkin Seed Asian Recipe
Fat Burning Bariatric Seed Trick Ritual
Disclaimer: Always consult your doctor before starting any supplement, and verify current pricing on the official GutDrops website, as prices and availability are subject to change.
If you're looking for a science-informed, lifestyle-friendly supplement that supports real metabolic change from the inside out, GutDrops Keto Drops may be the breakthrough your 2025 wellness plan has been missing.Bonus: 5 Daily Rituals to Supercharge GutDrops Keto Drops for Even Better Results
While GutDrops Keto Drops work effectively on their own, many users want to know how they can amplify the formula's effects. If you're looking to get the most out of your GutDrops Keto Drops weight loss journey, these simple lifestyle habits can help maximize gut health and accelerate your fat-burning progress.
These tips are optional, but they pair well with the Fat Burning Bariatric Seed Trick Ritual and help create a strong foundation for long-term results.
1. Begin Each Day with Warm Water and Lemon
A glass of warm water with fresh lemon first thing in the morning can gently stimulate digestion, flush out overnight waste, and prepare the gut for better nutrient absorption. It pairs well with GutDrops Keto Drops, especially before breakfast.
2. Avoid Artificial Sweeteners and Processed Oils
Even if you're not on a strict diet, cutting out common inflammatory foods can help rebalance gut flora faster. Artificial sweeteners such as aspartame and sucralose are known to disrupt the microbiota. At the same time, processed oils (e.g., canola, soybean) can increase systemic inflammation, making it harder to lose fat, even while using GutDrops.
3. Eat Fermented Foods 2–3 Times Per Week
Although GutDrops is not a probiotic supplement, supporting your gut with fermented foods like sauerkraut, kimchi, kefir, or plain yogurt can offer additional natural strains that work synergistically with the formula to enhance gut health.
4. Sleep at Least 7–8 Hours a Night
Poor sleep is a significant disruptor of hormonal balance and can negatively affect leptin and ghrelin, two hunger hormones. GutDrops may help reduce cravings, but pairing them with consistent sleep ensures better hunger regulation and metabolic function.
5. Use the LeanTrack App Daily
Every multi-month GutDrops plan comes with access to the LeanTrack App, your personalized wellness assistant. By logging your daily water intake, meals, mood, and weight, you'll gain deeper insight into your progress. The app also helps you stay consistent, a key to maintaining fat-burning results.
Why These Additions Matter
These daily rituals aren't mandatory, but they can significantly enhance your results. They align with the gut-first philosophy behind GutDrops Keto Drops and offer gentle lifestyle support without the need for extreme dieting or exercise regimens.
Whether you're starting with the Pumpkin Seed Asian Recipe, following the Fat Burning Bariatric Seed Trick Ritual, or simply looking to regain energy and confidence, stacking these simple steps on top of your GutDrops routine may be the boost you need to reach your goals faster.
Disclaimer: These tips are general wellness suggestions and not a substitute for professional medical advice. For personalized recommendations, consult a qualified health provider.Bonus: 7 Common Mistakes That Can Sabotage Your GutDrops Results
If you're committed to seeing fundamental, lasting changes with GutDrops Keto Drops, it's essential to make sure your daily habits aren't working against you. Even the best supplements can struggle to deliver results if the body is overwhelmed by hidden factors that damage gut health or block metabolic function.
Below are seven often-overlooked mistakes that could stall your progress—and how to fix them quickly.
Avoiding these pitfalls can help you get the most out of your GutDrops Keto Drops treatment plan, allowing the Fat Burning Bariatric Seed Trick Ritual to work precisely as intended.
1. Skipping Doses or Inconsistent Usage
The top reason users don't see results is inconsistency. Taking GutDrops Keto Drops before each meal is critical to achieving and sustaining the intended metabolic support and gut microbiota balance. Skipping doses slows the formula's cumulative effects.
2. Overeating Ultra-Processed Foods
Foods with long shelf lives, chemical additives, and artificial ingredients may kill beneficial gut bacteria, including the CSM-type fat-burning strains that GutDrops is designed to support. Even moderate reductions in processed food can lead to faster results.
3. Relying on Probiotics Alone
Probiotics have their place, but they often fail to displace toxic bacteria when the gut environment is out of balance. That's why GutDrops focuses on restoring this balance with high concentrations of phytosterols and supportive nutrients, not just adding more bacteria.
4. Not Drinking Enough Water
Water is essential for digestion, detoxification, and fat metabolism. Without it, your body may struggle to eliminate toxins and waste byproducts, slowing down the weight loss process, even while taking GutDrops daily.
5. Failing to Track Progress
If you aren't monitoring your weight, mood, cravings, or energy, you may miss signs that GutDrops is working. That's why the included LeanTrack App is a game-changer. It helps you stay aware, motivated, and accountable through your transformation.
6. Not Getting Enough Sleep
Gut bacteria repair and regenerate during deep sleep. Disrupted rest can affect how your body processes food, handles inflammation, and produces fat-regulating hormones. GutDrops works best in a well-rested system.
7. Giving Up Too Soon
Many users expect overnight transformation. While some experience rapid changes, others may not notice major shifts until the second or third week. Stay consistent. Most successful case studies—whether seen on Reddit, testimonials, or reviews—used GutDrops Keto Drops for at least 90 days.
Final Thoughts on GutDrops' Success
By avoiding these damaging yet straightforward habits, you can help ensure that GutDrops Keto Drops work precisely as intended, allowing your body to burn fat more efficiently, reduce cravings, and regain metabolic balance through gut microbiota restoration.
Combine these insights with the Pumpkin Seed Asian Recipe, maintain consistency with your dosing, and use the support tools provided through the official GutDrops website and LeanTrack App. These small changes can lead to massive shifts in results.
Disclaimer: This bonus section is for informational purposes only and not a substitute for professional medical guidance. Individual results will vary based on adherence and biological differences.Company: GutDrops
Address: 19655 E 35th Dr #100, Aurora, CO 80011
Email: support@thegutdrops.com
Phone Support: (866) 924-7412
Disclaimer
Legal Disclaimer and Affiliate Disclosure
The content presented in this article is for informational and educational purposes only and should not be considered a substitute for professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare provider before beginning any new supplement, health product, or fitness program, including the use of GutDrops Keto Drops or any product featured on this page.
Statements made within this article have not been evaluated by the Food and Drug Administration (FDA). GutDrops Keto Drops is not intended to diagnose, treat, cure, or prevent any disease or medical condition. Results discussed, including weight loss outcomes or user testimonials, are individual experiences and may not reflect the typical results that consumers will experience. Actual outcomes can and do vary depending on a wide range of personal health factors, adherence, and genetic makeup.
While every effort has been made to ensure the accuracy of the information contained herein, no guarantee is made that the content is free from errors, omissions, or outdated references. Should any inaccuracies or typographical issues exist, they are unintentional, and the publisher assumes no legal responsibility for such discrepancies.
This article may contain affiliate links, which means the publisher may receive a commission if a purchase is made through those links, at no additional cost to the consumer. The compensation received may influence the promotional content, topics covered, or positioning within this article; however, it does not affect the objectivity or integrity of the information provided. Readers are under no obligation to use affiliate links and are encouraged to conduct their independent research.
Any third-party trademarks, brand names, or product images are used for identification purposes only and are the property of their respective owners. References to specific products or therapies are not endorsements by any medical authority, nor do they imply a formal partnership or clinical validation.
All content is provided "as is" and with no warranties or guarantees, express or implied. Neither the publisher nor its authors, affiliates, marketers, distributors, editors, content partners, or syndication outlets will be held liable for any direct or indirect damages, loss of health, financial issues, or other consequences resulting from the use of any product or information mentioned in this publication.
By reading this content, the user acknowledges and agrees to assume full responsibility for their use of any products and services mentioned, and holds all parties involved harmless in perpetuity.
Always refer directly to the product's official website for official product information, ingredients, pricing, guarantees, and usage recommendations.
CONTACT: Company: GutDrops Address: 19655 E 35th Dr #100, Aurora, CO 80011 Email: support@thegutdrops.com Phone Support: (866) 924-7412
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Dupixent® (dupilumab) Demonstrated Superiority Over Xolair® (Omalizumab) in Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) in Patients with Coexisting Asthma in First-ever Presented Phase 4 Head-to-Head Respiratory Trial
By GlobeNewswire Published on June 15, 2025, 20:21 IST New late-breaking data at EAACI showed Dupixent outperformed Xolair across all primary and secondary efficacy endpoints of CRSwNP and in all asthma-related endpoints Dupixent also outperformed Xolair in improving such key signs and symptoms as nasal polyp size and sense of smell in CRSwNP, and lung function and disease control in asthma, with rapid improvements seen as early as 4 weeks Results reinforce the efficacy of Dupixent in treating both upper and lower respiratory diseases by targeting IL-4 and IL-13, two key drivers of type 2 inflammation TARRYTOWN, N.Y. and PARIS, June 15, 2025 (GLOBE NEWSWIRE) — Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented positive results from the EVEREST Phase 4 trial in adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma. In the trial, Dupixent® (dupilumab) outperformed Xolair® (omalizumab) on all primary and secondary efficacy endpoints of CRSwNP, and in all asthma-related endpoints. The data are from the first-ever presented head-to-head respiratory trial with biologic medicines and were shared in a late-breaking oral presentation at the 2025 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress. 'Patients suffering from chronic rhinosinusitis with nasal polyps often live with the constant obstruction of their nasal passages that can lead to burdensome nasal congestion and loss of smell. What's more, a majority of these individuals also have asthma that can substantially impact their quality of life,' said Eugenio De Corso, M.D., Ph.D., ENT Specialist, Otolaryngology, Head and Neck Surgery, Rhinology, A. Gemelli University Hospital Foundation, IRCSS, Rome, Italy, and lead investigator of the study. 'EVEREST is the first-ever trial to demonstrate the superiority of Dupixent over Xolair on CRSwNP endpoints in patients with coexisting asthma, along with generally similar safety profiles. Together, these Dupixent outcomes provide important insights that will help guide patients and physicians through the treatment decision-making process.' In the EVEREST trial, 360 adults with severe, uncontrolled CRSwNP and coexisting asthma were randomized to receive Dupixent 300 mg (n=181) every two weeks or a weight- and immunoglobulin E (IgE) level-based dosing regimen of Xolair (n=179) every two or four weeks. Both Dupixent and Xolair were added to background mometasone furoate nasal spray (MFNS). Primary and secondary endpoint results in CRSwNP for patients treated with Dupixent compared to Xolair at 24 weeks were as follows, with differences seen as early as 4 weeks: 1.60-point superior reduction in nasal polyp size , a primary endpoint (p<0.0001 a ) , a primary endpoint (p<0.0001 ) 8.0-point superior improvement in ability to identify different smells , a primary endpoint (p<0.0001 a ). More patients on Dupixent improved above the anosmia threshold compared to Xolair. , a primary endpoint (p<0.0001 ). More patients on Dupixent improved above the anosmia threshold compared to Xolair. 0.58-point superior reduction in nasal congestion/obstruction , a key secondary endpoint (p<0.0001 a ) , a key secondary endpoint (p<0.0001 ) 0.81-point superior improvement in loss of smell , a key secondary endpoint (p<0.0001 a ) , a key secondary endpoint (p<0.0001 ) 1.74-point superior reduction in symptom severity (p<0.0001 a ) (p<0.0001 ) 12.7-point difference in health-related quality of life (p<0.0001 b ) (p<0.0001 ) 31.27-point difference in peak nasal inspiratory flow (p<0.0001 b ) (p<0.0001 ) 1.87-point difference in overall severity of rhinosinusitis (p<0.0001b) Asthma endpoint results for patients treated with Dupixent compared to Xolair at 24 weeks were as follows, with differences seen as early as 4 weeks: 150 mL difference in lung function (pre-bronchodilator FEV 1 ; p=0.003 b ) (pre-bronchodilator FEV ; p=0.003 ) 0.48-point difference in asthma control (p<0.0001b) a Statistically significant b Nominally significant as the endpoint was not included in the multiplicity adjustment hierarchy The safety results in the EVEREST trial were generally consistent with the known safety profile of Dupixent in its approved respiratory indications, with similar overall rates of adverse events (AEs) observed between Dupixent (64%) and Xolair (67%). Serious AEs were reported in 2% and 4% of patients treated with Dupixent and Xolair, respectively. Additionally, AEs leading to trial discontinuation were reported in 3% of Dupixent patients and 1% of Xolair patients. About the Dupixent Phase 4 Trial EVEREST is a randomized, double-blind Phase 4 trial comparing the efficacy and safety of Dupixent to Xolair in adults with severe, uncontrolled CRSwNP and coexisting mild, moderate or severe asthma. During the 24-week trial, patients received Dupixent 300 mg every two weeks or Xolair 75 to 600 mg every two or four weeks, which was added to background MFNS. Xolair dosing was determined based on body weight and serum total IgE levels as per the approved label. All endpoints were assessed at 24 weeks. The primary endpoints assessed change from baseline in nasal polyp score (NPS; scale: 0-8) and the University of Pennsylvania Smell Identification Test (UPSIT; scale: 0-40). Secondary endpoints included change from baseline in nasal congestion (NC; scale: 0-3), loss of smell (LoS; scale: 0-3), total symptom score (TSS; scale: 0-9), Sino-Nasal Outcome Test-22 (SNOT-22; scale: 0-110), peak nasal inspiratory flow, and rhinosinusitis disease severity (visual analogue scale: 0-10 cm). Other endpoints assessed pre-bronchodilator forced expiratory volume over one second (pre-BD FEV 1 ) and the 7-item Asthma Control Questionnaire (ACQ-7; scale: 0-6). About Dupixent Dupixent, which was invented using Regeneron's proprietary VelocImmune ® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis (EoE), prurigo nodularis, chronic spontaneous urticaria (CSU) and chronic obstructive pulmonary disease (COPD) in different age populations. More than 1,000,000 patients are being treated with Dupixent globally.1 About Regeneron's VelocImmune Technology Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite ® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent® (dupilumab), Libtayo® (cemiplimab-rwlc), Praluent® (alirocumab), Kevzara® (sarilumab), Evkeeza® (evinacumab-dgnb), Inmazeb® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz® (pozelimab-bbfg). In addition, REGEN-COV® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024. Dupilumab Development Program Dupilumab is being jointly developed by Regeneron and Sanofi under a global collaboration agreement. To date, dupilumab has been studied across more than 60 clinical trials involving more than 10,000 patients with various chronic diseases driven in part by type 2 inflammation. In addition to the currently approved indications, Regeneron and Sanofi are studying dupilumab in a broad range of diseases driven by type 2 inflammation or other allergic processes in Phase 3 trials, including chronic pruritus of unknown origin, bullous pemphigoid and lichen simplex chronicus. These potential uses of dupilumab are currently under clinical investigation, and the safety and efficacy in these conditions have not been fully evaluated by any regulatory authority. U.S. INDICATIONS DUPIXENT is a prescription medicine used: to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids. It is not known if DUPIXENT is safe and effective in children with atopic dermatitis under 6 months of age. with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines. DUPIXENT helps prevent severe asthma attacks (exacerbations) and can improve your breathing. DUPIXENT may also help reduce the amount of oral corticosteroids you need while preventing severe asthma attacks and improving your breathing. It is not known if DUPIXENT is safe and effective in children with asthma under 6 years of age. with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled. It is not known if DUPIXENT is safe and effective in children with chronic rhinosinusitis with nasal polyps under 12 years of age. to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15 kg). It is not known if DUPIXENT is safe and effective in children with eosinophilic esophagitis under 1 year of age, or who weigh less than 33 pounds (15 kg). to treat adults with prurigo nodularis (PN). It is not known if DUPIXENT is safe and effective in children with prurigo nodularis under 18 years of age. with other medicines for the maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils (a type of white blood cell that may contribute to your COPD). DUPIXENT is used to reduce the number of flare-ups (the worsening of your COPD symptoms for several days) and can improve your breathing. It is not known if DUPIXENT is safe and effective in children with chronic obstructive pulmonary disease under 18 years of age. to treat adults and children 12 years of age and older with chronic spontaneous urticaria (CSU) who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if DUPIXENT is safe and effective in children with chronic spontaneous urticaria under 12 years of age, or who weigh less than 66 pounds (30 kg). DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine. DUPIXENT is not used to treat any other forms of hives (urticaria). IMPORTANT SAFETY INFORMATION Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®. Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you: have eye problems. have a parasitic (helminth) infection. are scheduled to receive any vaccinations. You should not receive a 'live vaccine' right before and during treatment with DUPIXENT. are pregnant or plan to become pregnant. It is not known whether DUPIXENT will harm your unborn baby. A pregnancy registry for women who take DUPIXENT during pregnancy collects information about the health of you and your baby. To enroll or get more information call 1-877-311-8972 or go to . are breastfeeding or plan to breastfeed. It is not known whether DUPIXENT passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, or chronic spontaneous urticaria, and also have asthma. Do not change or stop your other medicines, including corticosteroid medicine or other asthma medicine, without talking to your healthcare provider. This may cause other symptoms that were controlled by those medicines to come back. DUPIXENT can cause serious side effects, including: All e r g i c r ea c t i on s. DUPIXENT can cause allergic reactions that can sometimes be severe. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, joint pain, general ill feeling, itching, skin rash, swollen lymph nodes, nausea or vomiting, or cramps in your stomach-area. Stop using DUPIXENT and tell your healthcare provider or get emergency help right away if you get any of the following signs or symptoms: breathing problems or wheezing, swelling of the face, lips, mouth, tongue or throat, fainting, dizziness, feeling lightheaded, fast pulse, fever, hives, joint pain, general ill feeling, itching, skin rash, swollen lymph nodes, nausea or vomiting, or cramps in your stomach-area. E y e pr ob l e m s. Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed Tell your healthcare provider if you have any new or worsening eye problems, including eye pain or changes in vision, such as blurred vision. Your healthcare provider may send you to an ophthalmologist for an exam if needed I n fl a mm a t i o n o f y ou r b l oo d v e ss e l s. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. Tell your healthcare provider right away if you have: rash, chest pain, worsening shortness of breath, brown or dark colored urine, persistent fever, or a feeling of pins and needles or numbness of your arms or legs. Rarely, this can happen in people with asthma who receive DUPIXENT. This may happen in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. Tell your healthcare provider right away if you have: rash, chest pain, worsening shortness of breath, brown or dark colored urine, persistent fever, or a feeling of pins and needles or numbness of your arms or legs. Psoriasis. This can happen in people with atopic dermatitis and asthma who receive DUPIXENT. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination if needed. This can happen in people with atopic dermatitis and asthma who receive DUPIXENT. Tell your healthcare provider about any new skin symptoms. Your healthcare provider may send you to a dermatologist for an examination if needed. Joint aches and pain. Some people who use DUPIXENT have had trouble walking or moving due to their joint symptoms, and in some cases needed to be hospitalized. Tell your healthcare provider about any new or worsening joint symptoms. Your healthcare provider may stop DUPIXENT if you develop joint symptoms. The most common side effects include: Eczema: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, dry eye, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia). injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, dry eye, cold sores in your mouth or on your lips, and high count of a certain white blood cell (eosinophilia). A s t h ma: injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections. injection site reactions, high count of a certain white blood cell (eosinophilia), pain in the throat (oropharyngeal pain), and parasitic (helminth) infections. C h r on i c R h i no s i nu s i t i s w i th N a s a l P o ly p s: injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, high count of a certain white blood cell (eosinophilia), gastritis, joint pain (arthralgia), trouble sleeping (insomnia), and toothache. injection site reactions, eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, high count of a certain white blood cell (eosinophilia), gastritis, joint pain (arthralgia), trouble sleeping (insomnia), and toothache. Eosinophilic Esophagitis: injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia). injection site reactions, upper respiratory tract infections, cold sores in your mouth or on your lips, and joint pain (arthralgia). Prurigo Nodularis: eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea. eye and eyelid inflammation, including redness, swelling, and itching, sometimes with blurred vision, herpes virus infections, common cold symptoms (nasopharyngitis), dizziness, muscle pain, and diarrhea. Chronic Obstructive Pulmonary Disease: injection site reactions, common cold symptoms (nasopharyngitis), high count of a certain white blood cell (eosinophilia), viral infection, back pain, inflammation inside the nose (rhinitis), diarrhea, gastritis, joint pain (arthralgia), toothache, headache, and urinary tract infection. injection site reactions, common cold symptoms (nasopharyngitis), high count of a certain white blood cell (eosinophilia), viral infection, back pain, inflammation inside the nose (rhinitis), diarrhea, gastritis, joint pain (arthralgia), toothache, headache, and urinary tract infection. Chronic Spontaneous Urticaria: injection site reactions. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of DUPIXENT. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088. Use DUPIXENT exactly as prescribed by your healthcare provider. It's an injection given under the skin (subcutaneous injection). Your healthcare provider will decide if you or your caregiver can inject DUPIXENT. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider. In children 12 years of age and older, it's recommended DUPIXENT be administered by or under supervision of an adult. In children 6 months to less than 12 years of age, DUPIXENT should be given by a caregiver. Please see accompanying full Prescribing Information including Patient Information. About Regeneron Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases. Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases. For more information, please visit or follow Regeneron on LinkedIn, Instagram, Facebook or X. About Sanofi Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time. Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY. Regeneron Forward-Looking Statements and Use of Digital Media This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ('Regeneron' or the 'Company'), and actual events or results may differ materially from these forward-looking statements. Words such as 'anticipate,' 'expect,' 'intend,' 'plan,' 'believe,' 'seek,' 'estimate,' variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Products') and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, 'Regeneron's Product Candidates') and research and clinical programs now underway or planned, including without limitation Dupixent ® (dupilumab) for the treatment of chronic rhinosinusitis with nasal polyps as discussed in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron's Products and Regeneron's Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron's Product Candidates and new indications for Regeneron's Products, such as Dupixent for the treatment of chronic pruritus of unknown origin, bullous pemphigoid, lichen simplex chronicus, and other potential indications; the ability of Regeneron's collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron's Products and Regeneron's Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron's Products (such as Dupixent) and Regeneron's Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron's Products and Regeneron's Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's Products and Regeneron's Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron's Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron's Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron's Products and Regeneron's Product Candidates (including biosimilar versions of Regeneron's Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron's agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA ® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron's business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron's filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024 and its Form 10-Q for the quarterly period ended March 31, 2025. Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise. Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website ( and its LinkedIn page ( Sanofi Disclaimers or Forward-Looking Statements This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates regarding the marketing and other potential of the product, or regarding potential future revenues from the product. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans', and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, unexpected regulatory actions or delays, or government regulation generally, that could affect the availability or commercial potential of the product, the fact that product may not be commercially successful, the uncertainties inherent in research and development, including future clinical data and analysis of existing clinical data relating to the product, including post marketing, unexpected safety, quality or manufacturing issues, competition in general, risks associated with intellectual property and any related future litigation and the ultimate outcome of such litigation, and volatile economic and market conditions, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements. All trademarks shown are property of their respective owners. 1 Data on File Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. Ahmedabad Plane Crash GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.


Business Upturn
35 minutes ago
- Business Upturn
Intellia Therapeutics Announces Positive Three-Year Data from Phase 1 Trial of Lonvoguran Ziclumeran (lonvo-z) in Patients with Hereditary Angioedema (HAE) at the European Academy of Allergy and Clinical Immunology Congress
With up to three years of follow-up, a single dose of lonvo-z led to a 98% mean reduction in monthly HAE attack rate in all 10 patients All 10 patients were attack-free and treatment-free for a median of 23 months through the latest follow-up, demonstrating the potential of lonvo-z to become the first one-time therapy for most HAE patients Lonvo-z was well tolerated and continues to demonstrate a favorable safety profile The global Phase 3 HAELO trial of lonvo-z has concluded screening ahead of schedule with more than half screened from U.S. sites; Intellia to provide an update on enrollment in the future CAMBRIDGE, Mass., June 15, 2025 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies, today announced three-year follow-up data from the Phase 1 portion of the ongoing Phase 1/2 study in patients with HAE after receiving a single dose of lonvoguran ziclumeran (lonvo-z, also known as NTLA-2002). Results were shared in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, held June 13-16 in Glasgow, United Kingdom. 'Today's results underscore the promising potential of Intellia's approach to gene editing therapy – a one-time treatment that was well tolerated and offered a highly differentiated, durable effect for patients suffering from a serious disease,' said Intellia President and Chief Executive Officer John Leonard, M.D. 'Seeing all 10 patients in the Phase 1 portion of this study free from both HAE attacks and chronic therapy at nearly two years of median follow-up is incredibly encouraging. These data fuel our optimism for the outcomes of our ongoing Phase 3 HAELO study, which we expect to report in the first half of 2026, and highlight the strong value we believe it will offer patients, physicians and payers.' 'People living with HAE often report a reduced quality of life because they worry about the likelihood of their next attack, either because they still experience attacks or are reminded of it by their use of chronic therapy,' said Dr. Joshua Jacobs, Medical Director, Allergy and Asthma Clinical Research, Inc. 'Based on the data, it is reasonable to expect lonvo-z could offer patients the potential to be free from both physical HAE attacks and the burden of managing chronic HAE treatment.' In the Phase 1 portion of the study, a one-time dose of 25 mg (N=3), 50 mg (N=4) or 75 mg (N=3) of lonvo-z was administered via intravenous infusion and plasma kallikrein protein levels were measured along with HAE attacks. At the time of the February 12 data cutoff, patients were attack-free and treatment-free for a median of nearly two years. With up to three years of follow-up, a single dose of lonvo-z led to a mean reduction in monthly HAE attack rate of 98% over the study period, compared to pre-treatment baseline. For all 10 patients, deep, dose-dependent and durable reductions in plasma kallikrein protein continued to be observed through the latest assessment. Safety Across all three dose levels, lonvo-z has been well tolerated and continues to demonstrate a favorable safety profile consistent with earlier data presented at EAACI in 2024. The most frequent adverse events during the study period were infusion-related reactions (IRRs). IRRs were mostly Grade 1 and resolved with all patients receiving the full dose. With up to 3 years of follow-up, no treatment-emergent serious adverse events were observed, and no treatment-related adverse events were observed during the period following 28 days after dosing. Clinical Development Plans Intellia's global Phase 3, randomized, double-blind, placebo-controlled HAELO trial is ongoing to assess the safety and efficacy of lonvo-z at the 50 mg dosage. The Company announced today the HAELO trial has successfully completed screening ahead of schedule, with over half of the patients being screened in the United States. The study is no longer recruiting and Intellia will provide an update on enrollment in the future. New and longer-term data from the Phase 2 portion of the ongoing Phase 1/2 study is planned to be presented in the second half of 2025. Intellia expects to submit a biologics license application (BLA) in 2026 to support the Company's plans for a U.S. launch in 2027. For more information on HAELO (NCT06634420), please visit About the Lonvoguran Ziclumeran (lonvo-z, also known as NTLA-2002) Clinical Program Intellia's ongoing Phase 1/2 study is evaluating the safety and efficacy of lonvo-z in adults with Type I or Type II hereditary angioedema (HAE). The Phase 1 portion of the study is an international, open-label study designed to identify the dose level of lonvo-z selected for further evaluation in the Phase 2 portion of the study. Enrollment in both portions of the Phase 1/2 study is complete. Intellia dosed the first patient in the global Phase 3, randomized, double-blind, placebo-controlled HAELO trial in January of 2025. Visit (NCT05120830) for more details. About Lonvo-z Based on Nobel Prize-winning CRISPR/Cas9 technology, lonvo-z has the potential to become the first one-time treatment for hereditary angioedema (HAE). Lonvo-z is an investigational in vivo CRISPR-based gene editing therapy designed to prevent HAE attacks by inactivating the kallikrein B1 ( KLKB1 ) gene, which encodes for prekallikrein, the kallikrein precursor protein. Interim Phase 1/2 clinical data showed dramatic reductions in attack rate, as well as consistent, deep and durable reductions in kallikrein levels. Lonvo-z has received five notable regulatory designations, including Orphan Drug and RMAT Designation by the U.S. Food and Drug Administration (FDA), the Innovation Passport by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), Priority Medicines (PRIME) Designation by the European Medicines Agency, as well as Orphan Drug Designation (ODD) by the European Commission. About Intellia Therapeutics Intellia Therapeutics, Inc. (NASDAQ:NTLA) is a leading clinical-stage gene editing company focused on revolutionizing medicine with CRISPR-based therapies. Since its inception, Intellia has focused on leveraging gene editing technology to develop novel, first-in-class medicines that address important unmet medical needs and advance the treatment paradigm for patients. Intellia's deep scientific, technical and clinical development experience, along with its people, is helping set the standard for a new class of medicine. To harness the full potential of gene editing, Intellia continues to expand the capabilities of its CRISPR-based platform with novel editing and delivery technologies. Learn more at and follow us @intelliatx. Forward-Looking Statements This press release contains 'forward-looking statements' of Intellia Therapeutics, Inc. ('Intellia' or the 'Company') within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia's beliefs and expectations concerning: the safety, efficacy, success and advancement of its clinical programs for lonvoguran ziclumeran or 'lonvo-z' (also known as NTLA-2002) for hereditary angioedema ('HAE'), including the ability to successfully complete its global Phase 3 HAELO study; its expectation to present additional data regarding lonvo-z, including reporting outcomes of the Phase 3 HAELO study in the first half of 2026 and presenting new and longer-term data from the Phase 2 portion of the ongoing Phase 1/2 study of lonvo-z in the second half of 2025; and its expectation to be able to support a biologics license application for lonvo-z for the treatment of HAE by 2026 for a U.S. launch in 2027. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to Intellia's ability to protect and maintain its intellectual property position; risks related to Intellia's relationship with third parties, including its contract manufacturers, licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; risks related to Intellia's ability to protect and maintain its intellectual property position; risks related to valid third party intellectual property; risks related to Intellia's relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to regulatory agencies' evaluation of regulatory filings and other information related to our product candidates, including lonvo-z; uncertainties related to the authorization, initiation and conduct of studies and other development requirements for our product candidates, including uncertainties related to regulatory approvals to conduct clinical trials, including our ability to complete the Phase 3 HAELO study for HAE; the risk that any one or more of Intellia's product candidates, including lonvo-z, will not be successfully developed and commercialized; and the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies for the same product candidate or Intellia's other product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia's actual results to differ from those contained in the forward-looking statements, see the section entitled 'Risk Factors' in Intellia's most recent annual report of Form 10-K and quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Intellia's other filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Intellia undertakes no duty to update this information unless required by law. Intellia Contacts: Investors:Brittany ChavesSenior Manager, Investor Relations [email protected]


Business Upturn
5 hours ago
- Business Upturn
Investigational combination of first-in-class bispecific antibodies TALVEY®▼ (talquetamab) and TECVAYLI®▼ (teclistamab) shows deep and durable responses in heavily pretreated multiple myeloma patients
Results from the Phase 2 RedirecTT-1 study demonstrate deep responses with 78.9 percent overall response rate through dual targeting of GPRC5D and BCMA1 Data signal potential of novel, off-the-shelf approach in patients with extramedullary disease who face significant unmet needs1 Advertisement BEERSE, BELGIUM, June 15, 2025 (GLOBE NEWSWIRE) — Janssen-Cilag International NV, a Johnson & Johnson company, announced today new results from the Phase 2 RedirecTT-1 study evaluating the investigational combination of TALVEY®▼(talquetamab), the first European Commission (EC) approved GPRC5D-directed bispecific antibody, and TECVAYLI®▼(teclistamab), the first EC approved BCMA-directed bispecific antibody. The results show a high overall response rate (ORR) with durability in patients with triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) who have true extramedullary disease (EMD).1 EMD is defined as soft tissue/organ-associated plasmacytomas with no contact to bony structures as per International Myeloma Working Group (IMWG) criteria.2 RedirecTT-1 is the largest study dedicated to patients with EMD to date.1 These data were featured in a late-breaking oral presentation (Abstract #LB4001) at the 2025 European Hematology Association (EHA) Congress.1 EMD represents an aggressive form of multiple myeloma and occurs when myeloma cells spread and form tumours (plasmacytomas) elsewhere in the body, such as in soft tissues and organs.3 These patients often face limited treatment options and worse outcomes due to the complexity of the disease, including tumour heterogeneity, resulting in low ORRs and rapid relapses with current standard therapies.2,3 On average, TCE RRMM patients with EMD have an ORR of less than 40 percent and a median progression-free survival (PFS) of less than six months.4 'The investigational combination of talquetamab and teclistamab has demonstrated deep, durable responses in patients with relapsed or refractory multiple myeloma, and now shows great promise in those with extramedullary myeloma, where standard therapies often fall short,' said Yael Cohen, M.D., Head of Myeloma Unit, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.* 'Dual targeting of GPRC5D and BCMA may lead to a higher ORR and greater depth of response by mitigating target antigen-related escape. The RedirecTT-1 trial shows the power of this novel dual-targeting combination approach as a potential treatment option for patients with this disease.' The Phase 2 RedirecTT-1 study enrolled 90 patients with TCE RRMM with true EMD.1 Of these patients, 84.4 percent were triple-class refractory, 35.6 percent were penta-drug refractory, 20.0 percent had previously received BCMA CAR-T therapy, and 8.9 percent had previously received a bispecific antibody.1 The investigational combination of talquetamab and teclistamab led to a high ORR of 78.9 percent (95 percent confidence interval [CI]; 69.0–86.8), with more than half of patients (54.4 percent) achieving complete response or better.1 High responses were observed even in patients exposed to prior BCMA CAR-T or anti-FcRH5 bispecific antibodies (83.3 percent ORR; 58.6-96.4 and 75.0 percent ORR; 34.9-96.8, respectively).1 Among responders, 66.2 percent remained in response at the data cutoff, with a median follow-up of 13.4 months, signalling deep and durable responses.1 Treatment with the combination resulted in 61.0 percent of patients progression-free and alive at one year.1 Additionally, the combination led to durable responses, with 64.1 percent of patients maintaining response (median duration of response: 13.8 months) and 74.5 percent of patients alive at one year, while median overall survival was not yet reached.1 'Multiple myeloma remains a complex and heterogeneous disease, with extramedullary disease presenting a particularly aggressive and challenging to treat form,' said Ester in't Groen, EMEA Therapeutic Area Head Haematology at Johnson & Johnson Innovative Medicine. 'The RedirecTT-1 study reflects our strategy to harness novel mechanisms of action, such as the combination of these dual bispecific antibodies, to help redefine potential outcomes for subsets of patients who are currently faced with a poor prognosis and limited options.' The safety profile of the combination was consistent with previous reports of talquetamab and teclistamab as monotherapies, with no new safety signals identified.1 Patients were given the option to switch to once a month dosing potentially contributing to improved tolerability.1 Rates of discontinuation were low with the treatment combination of talquetamab and teclistamab due to adverse events (AEs).1 Four participants discontinued talquetamab only.1 Reports of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were mostly low grade.1 Of the ten patients who had Grade 5 AEs (11.1 percent), five were due to infections.1 There were five patient deaths due to infection and the rates of severe infection were similar to those observed with some BCMA bispecific antibody monotherapies.1 'Patients with extramedullary myeloma, especially those who have exhausted prior therapies, need more effective treatment options,' said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. 'Our first-in-class bispecific antibodies talquetamab and teclistamab have transformed treatment for relapsed or refractory multiple myeloma. The RedirecTT-1 study underscores our commitment to advancing innovative therapies that attack the disease in different ways by building combinable and complementary regimens.' About Talquetamab Talquetamab received conditional marketing authorisation (CMA) from the European Commission (EC) in August 2023, as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.5 The U.S. Food and Drug Administration (FDA) also granted talquetamab approval in August 2023, for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.6 Talquetamab is a bispecific T-cell engaging antibody that binds to CD3 on the surface of T-cells, and GPRC5D, a novel target which is highly expressed on the surface of multiple myeloma cells, with minimal to no expression detected on B-cells or B-cell precursors.5 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using talquetamab, please refer to the Summary of Product Characteristics. In line with European Medicine Agency (EMA) regulations for new medicines and those given conditional approval, talquetamab is subject to additional monitoring. About Teclistamab Teclistamab received EC approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.7 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.8 Teclistamab received approval from the U.S. FDA in October 2022 for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.9 Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.9,10 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body's immune system to fight the cancer. Teclistamab is currently being evaluated in several combination studies.10,11,12,13,14 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics. In line with European Medicine Agency (EMA) regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring. About Multiple Myeloma Multiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.15,16 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.15,16 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.17 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy18,19 while remissions become progressively shorter.18,19,20 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.21 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at Follow us at Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamab and talquetamab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. * Yael Cohen, M.D., Head of Myeloma Unit, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel., has provided consulting, advisory and speaking services to Janssen-Cilag International NV; she has not been paid for any media work. ### 1 Kumar S, et al. Phase 2 study of Talquetamab + Teclistamab in Patients with Relapsed/Refractory Multiple Myeloma with Extramedullary Disease: presentation at 2025 European Hematology Association (EHA) Congress; June 12-15, 2025. 2 Ho M, et Multiple Myeloma: Challenges and Opportunities. Curr. Oncol, 2025; 32: 182. 3 Blade J, et al. Extramedullary Disease in Multiple Myeloma: a Systematic Literature Review. Blood Cancer J, 2022; 12(3):45. 4 Moreau P, et al. Outcomes of Patients With Extramedullary Disease in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma From the Pooled LocoMMotion and MoMMent Studies. Clinical Lymphoma, Myeloma and Leukemia, 2025; 25: S2152-2650. 5 European Medicines Agency. TALVEY Summary of Product Characteristics. Available at: Last accessed: June 2025. 6 FDA. FDA Grants Accelerated Approval to Talquetamab-tgvs for Relapsed or Refractory Multiple Myeloma. Available at: Last accessed: June 2025. 7 Janssen Marks First Approval Worldwide. 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