Latest news with #Semaglutide
Business Insider
2 days ago
- Business
- Business Insider
Hims Stock at $50: Here's What Truist Expects Next
Hims & Hers Health (NYSE:HIMS) stock has had a curious run in 2025. The first half of the year was marked by a massive 35% single-day plunge, sparked by Novo Nordisk's sudden decision to cut ties with the telehealth company. The Danish drugmaker accused Hims & Hers of engaging in misleading marketing and distributing unauthorized compounded versions of its blockbuster weight-loss drug, Wegovy. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. Despite the controversy, the stock has staged an impressive rebound, with shares up 108% year-to-date and now hovering around $50. The rally has been driven by strong quarterly results and growing momentum in the company's weight-loss offerings. Looking ahead, all eyes now turn to the company's upcoming Q2 earnings report, slated for August 4. Truist analyst Jailendra Singh expects results to land mostly in line with expectations, noting that current forecasts already reflect the high end of HIMS' guidance. He projects revenue of $549.4 million and adjusted EBITDA of $74.4 million, closely aligned with Street consensus and the company's provided range. However, Singh also flags some cautionary signals. The analyst anticipates a slight dip in online revenue per subscriber compared to Q1, attributing it to seasonal trends and reduced reliance on commercially available Semaglutide. Q1's outperformance, after all, benefited from one-off drivers like the Super Bowl ad and the initial buzz around HIMS-branded weight-loss offerings. That brings up the bigger question: where does HIMS go from here in the second half of the year? While some investors worry about a potential guidance cut following the Novo fallout, others are optimistic about a lift tied to the recent acquisition of European telemedicine provider Zava. Singh, for his part, remains cautious. The analyst believes a 2H ramp may be difficult unless Zava or other acquisitions begin to meaningfully contribute. Still, he doesn't expect management to revise guidance just yet, preferring to wait and assess the impact of new initiatives in Q3. As for upcoming developments to watch, Singh cites updates on a possible lawsuit from Novo Nordisk (which would be negative), new product launches in testosterone and menopause treatments (positive), and further M&A activity (also positive). 'From additional M&A point of view, a transaction giving the company entry into the employer/payor market will be transformational and has potential to change the narrative,' Singh further said. What to Do with HIMS Stock Now? Singh is sticking with a Hold (i.e., Neutral) rating, nudging his price target up from $45 to $48, which still suggests ~5% downside from where the stock is currently trading. (To watch Singh's track record, click here) And he's not alone in that cautious stance. The broader analyst community is mostly on the sidelines too, with 7 Holds, 2 Sells, and just 1 Buy – all coalescing to a Hold consensus rating. Based on the average price target of $41.78, the Street sees the stock pulling back by 17% over the next year. (See HIMS stock forecast) To find good ideas for stocks trading at attractive valuations, visit TipRanks' Best Stocks to Buy, a tool that unites all of TipRanks' equity insights.
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Business Standard
2 days ago
- Business
- Business Standard
CDMOs gear up for peptide boom amid rising demand for weight-loss drugs
As global demand for next-generation weight-loss and diabetes therapeutics surges, India's contract development and manufacturing organisations (CDMOs) are strategically positioning themselves to capture a bigger share of the peptide market, particularly in anticipation of key patent expiries such as that of semaglutide—a blockbuster GLP-1 receptor agonist. India is poised to play a critical role in the global manufacturing of GLP-1 drugs, driven by soaring demand for therapies like semaglutide and tirzepatide. The GLP-1 market is projected to exceed $150 billion by 2030. India's peptide CDMO market, currently estimated at around $80 million, is expected to grow at a CAGR of 14 per cent until 2030. Though the country currently accounts for just 3 per cent of the global peptide CDMO space—valued at $190 billion—the growth momentum is unmistakable, according to Nilaya Varma, Co-founder and Group CEO of Primus Partners. Top Indian players in the space include Glenmark, Cipla, Divi's Laboratories, Themis Medicare, Peptomer Therapeutics, Syngene International, and Sai Life Sciences. Semaglutide patent expiry fuels strategic activity Semaglutide, the active ingredient in drugs such as Ozempic and Wegovy, is owned and produced by Novo Nordisk and is set to go off-patent in India in March 2026. Leading pharmaceutical companies, including Dr Reddy's Laboratories, Sun Pharma, Cipla, Mankind Pharma, Natco Pharma, Lupin, and Biocon, are preparing to launch drugs in this category. These companies are investing in R&D, manufacturing capacity, and collaborations to compete in this rapidly growing market. Anthem Biosciences is experiencing a surge in inquiries for peptide active pharmaceutical ingredients (APIs), including those related to weight loss. 'Semaglutide can be produced through total synthesis or biosynthetic routes. Very few companies in India can manage biosynthetic production—and we are one of them,' said Ganesh Sambasivam, Promoter and Chief Scientific Officer at Anthem. While he declined to confirm whether semaglutide is in active production at Anthem, he hinted that it may be among the peptides currently in development. Syngene highlights technical edge in peptide trials Jayashree Aiyar, Chief Scientific Officer at Syngene International, sees opportunities not just in manufacturing, but also in preclinical and clinical development. 'We've already supported preclinical studies on semaglutide and recently helped a global pharma company with a bioequivalence study using pre-filled pens,' Aiyar said. These studies included developing and validating sensitive LC-MS/MS methods to measure semaglutide plasma levels—a significant technical challenge for peptides. Syngene's case study on semaglutide demonstrates the rigorous planning and execution required for clinical bioequivalence trials involving peptides. With gastrointestinal side effects common among test subjects, the company had to implement robust risk management and continuous patient support mechanisms. On the analytical front, it overcame complex challenges like autosampler carryover and low detection limits through custom-developed chromatography and mass spectrometry protocols. 'While we are not currently manufacturing GLP-1 APIs, we are well-equipped with peptide scale-up and fill–finish capabilities. We continue to invest in technologies to meet future market needs,' Aiyar added. Production and compliance challenges persist However, peptide manufacturing comes with its own set of challenges. 'There are production hurdles involving the availability of protected amino acids, coupling reagents, and advanced purification protocols, particularly for bulk APIs,' Varma noted. These challenges, combined with high utility costs and stringent environmental controls, add pressure to meet international compliance standards. Schemes such as the 2024 Production Linked Incentive (PLI) and Greenfield Bulk Drug Park initiatives are expected to ease some of these bottlenecks. While some CDMOs are already entrenched in the space, others are evaluating the landscape. Kashmik Formulations, for instance, is not currently working on semaglutide or related APIs, nor has it received client inquiries. However, the company sees the patent expiry of semaglutide as a potential inflection point. 'We're open to collaborations with larger players who can provide validated processes,' the company said in a statement. Diabetes burden drives urgency for scalable solutions The spike in demand is closely linked to a global epidemic of lifestyle diseases. Arushi Jain, Director at Akums Drugs & Pharmaceuticals, underscores this urgency. 'Over 100 million Indians are living with diabetes, underlining the need for scalable therapeutic solutions that address root causes such as obesity.' Akums is actively tracking developments in weight-loss APIs. As patents for semaglutide and similar molecules expire, Indian CDMOs are gearing up for a new wave of growth. Equipped with scientific expertise, evolving infrastructure, and an appetite for collaboration, the Indian peptide manufacturing ecosystem is emerging as a vital player in the global fight against obesity and metabolic diseases.
Gizmodo
4 days ago
- Health
- Gizmodo
This Simple Strategy Could Curb One of Semaglutide's Worst Side Effects
Semaglutide's ability to help people lose weight is legendary, but so are the side effects. The active ingredient in medications Wegovy and Ozempic, semaglutide is renowned for causing severe nausea in some people, sometimes to the extent that they stop treatment. But new research published in the journal Diabetes Care suggests there may be a simple way to combat that effect. Led by a team in Israel, the researchers found that giving people more time and flexibility to ramp up to the recommended 1 milligram dose of the drug seemed correlated with lower levels of nausea. People who followed the slower dosing schedule also seemed less likely to stop using the drug than those who followed a more typical regimen. What's more, the slow-and-steady group still lost about as much weight as their peers. Semaglutide works by mimicking GLP-1, a hormone that plays a key role in regulating our metabolism and hunger. Since U.S. regulators first approved the drug in 2017 to treat diabetes, it has become highly sought after for its appetite-stifling effects and weight-loss benefits—but it has its trade-offs. At least a third of people taking GLP-1s report feeling nauseous, while others also experience constipation and gastrointestinal distress. How Ozempic Works—and What's Still a Mystery As people increase their dose of the drug, the unpleasant GI effects can get worse before they get better. Typically, they fade over time once people reach their recommended dose, but at least some never make it that far and just stop taking the medication. In the new trial, researchers split 104 people with type 2 diabetes into two groups: One set took increasing amounts of semaglutide on a typical, 8-week dosing program, while the other group ramped up their dose on a slower, more flexible schedule that took 16 weeks. People in the second group were also told to hold off on upping their dose if they experienced any GI symptoms and wait till they felt better. Both groups were tracked for 24 weeks. Overall, both groups saw similar improvements to their weight and blood sugar control. But flexible users were less likely to report having nausea than their peers (45.1% vs 64.2%), and experienced fewer days of nausea (2.88 vs 6.3 days per month). Perhaps most notably, only 2% of flexible patients stopped taking the drug by the study's end, compared to 19% of standard users. 'Slower, flexible titration improved adherence and reduced adverse events without compromising efficacy,' the study authors wrote. 'Extremely Severe' Obesity in American Kids Is Surging, Study Finds While some doctors have anecdotally reported similarly positive experiences in their patients who switched to a slower schedule, the study's results are limited: The sample size is quite small, for one, and more work in larger and more diverse groups will be needed to understand if different dosing schedules could help more people stay on their medication, without getting the pukes.
Mint
5 days ago
- Health
- Mint
Does insurance cover weight-loss injections or bariatric surgery?
Obesity is no longer seen as a cosmetic issue — it's a chronic lifestyle disease linked to diabetes, hypertension, sleep apnea, and infertility. The Indian insurance industry has begun to recognize this shift. However, coverage still varies across types of treatment — bariatric surgery versus injections. The Insurance Regulatory and Development Authority of India (IRDAI) issued a landmark circular in October 2020 that made it mandatory for all health insurers to include coverage for medically necessary bariatric surgery under certain conditions. As per the guidelines: 'Bariatric surgery shall not be excluded when it is medically necessary and prescribed by a medical practitioner for treatment of obesity and co-morbid conditions.' BMI ≥ 40 (morbid obesity) without comorbidities, or BMI ≥ 35 with serious co-morbidities, such as type 2 diabetes, hypertension, obstructive sleep apnea and heart disease This move was a big shift, as earlier, most insurers treated bariatric surgery as a cosmetic or elective procedure. Now, if these medical thresholds are met, hospitalisation costs and surgery can be covered, subject to policy terms, waiting periods, and exclusions. In contrast, anti-obesity injections — such as GLP-1 receptor agonists like Semaglutide (Ozempic/Wegovy) and Liraglutide (Saxenda) — are still not universally covered. But, Ozempic (Semaglutide) is approved in India for Type 2 diabetes. If prescribed as part of diabetes management, it may be covered under policies that allow outpatient benefits or chronic care riders. Saxenda, which is approved abroad for weight loss but not yet widely approved for obesity in India, is typically not covered, especially for standalone weight loss. Most policies still exclude weight-loss medications under general exclusions unless they are part of the treatment of a covered illness. Review your policy documents for clauses around bariatric surgery and chronic condition riders. If you have Type 2 diabetes, PCOS, or cardiovascular risk, and have been prescribed GLP-1 injections, you may request pre-authorisation or medical necessity documentation and check The 2020 Irdai directive opened the door for medically necessary bariatric surgery, which is a big win for people with morbid obesity and related health issues. While insurance for obesity injections is still evolving, growing awareness and medical necessity documentation may improve chances of approval. Shilpa Arora is co-founder & COO at Insurance Samadhan.
Globe and Mail
6 days ago
- Business
- Globe and Mail
Biosimilars Market worth US$72.29 billion by 2035 with 7.5% CAGR
The biosimilars market is estimated to reach USD 66.9 billion by 2028 from USD 29.4 billion in 2023, at a CAGR of 17.8% during the forecast period. The growth of this market is mainly driven by rising demand for biosimilars in developed and developing countries, favorable reimbursement policies and launch of novel biosimilars in the market. The global Biosimilars Market, valued at US$32.75 billion in 2024 stood at US$35.04 billion in 2025 and is projected to advance at a resilient CAGR of 7.5% from 2025 to 2035, culminating in a forecasted valuation of US$72.29 billion by the end of the period. This growth is driven by several key factors, including a rising number of regulatory approvals and product launches, the patent expiries of major biologics, and the increasing prevalence of chronic diseases that require effective and affordable treatment options. Furthermore, cost containment pressures in global healthcare systems and a surge in R&D collaborations among biopharma companies have significantly accelerated biosimilar development and commercialization. Notably, the first biosimilar version of the blockbuster GLP-1 agonist Semaglutide is projected to launch in China by 2026, and it is anticipated to contribute to approximately 25% of the global biosimilars market share by 2035, underscoring its transformative impact on the market landscape. However, the intricacies involved in the manufacturing processes of biosimilars may present challenges that could impede market expansion throughout the forecast period. Browse in-depth TOC on " Biosimilars Market" 420 - Tables 58 - Figures 391 - Pages By indication, the escalating global burden of cancer, coupled with the high costs associated with biologic therapies, has positioned oncology as the leading segment in the biosimilars market. These biologic medications offer a cost-effective alternative to reference products, thereby improving patient access to crucial treatments. The heightened investment in R&D within oncology has established biosimilars as a strategic option for healthcare systems aiming to enhance treatment affordability. The primary biosimilars utilized for oncological treatments include trastuzumab, bevacizumab, rituximab, filgrastim, epoetin alfa, and denosumab. Ongoing regulatory approvals continue to expand this market segment, while sustained research initiatives and collaborative endeavors are poised to augment market development further. By Drug Class, Infliximab, rituximab, adalimumab, trastuzumab, pembrolizumab, dupilumab, ustekinumab, risankizumab, and other monoclonal antibodies are biologic therapeutics for managing autoimmune diseases, malignancies, chronic conditions, and infectious diseases. These agents are engineered through recombinant DNA (rDNA) technology, enabling them to selectively target specific antigens or cellular receptors, which enhances their therapeutic efficacy and specificity. The introduction of biosimilars for these established mAbs has the potential to significantly reduce healthcare expenditures while improving patient access to vital therapies. Moreover, with the patent expirations of several prominent mAbs, the subsequent surge in market competition is expected to drive down prices and generate increased pharmaceutical interest in mAb development. Given their affordability and versatility across oncology and autoimmune therapy, mAb biosimilars are poised to play a pivotal role in shaping the future landscape of therapeutic options. By geography, the European market has emerged as the leading contributor to the biosimilar sector, driven by pro-biosimilar governmental policies, heightened investments in research and development, and an increasing disease burden. Key suppliers in this arena include France, Italy, Spain, Germany, and the UK. The European Medicines Agency (EMA) has approved 132 biosimilars across various therapeutic classes, enhancing patient access, lowering treatment costs, and expediting market entry. This approval encompasses a range of biologics, including insulin, TNF inhibitors, VEGF inhibitors, and monoclonal antibodies. Notably, in February 2025, the European Commission approved YESINTEK, Biocon Biologics' biosimilar of ustekinumab, underscoring Europe's commitment to improving access to biologic therapies and reinforcing its leadership position in the global biosimilars landscape. Key players in the biosimilars market include Sandoz Group AG (Switzerland), Pfizer Inc. (US), Amgen Inc. (US), Celltrion, Inc. (South Korea), Biocon (India), Dr. Reddy's Laboratories Ltd. (India), Eli Lilly and Company (US), Teva Pharmaceutical Industries Ltd. (Israel), Fresenius Kabi AG (Germany), and STADA Arzneimittel AG (Germany). Biocon (India): In March 2025, Biocon entered into a strategic collaboration with Civica, Inc. to manufacture and market insulin Aspart in the US jointly. As per the agreement, Biocon will provide the drug substance for insulin Aspart, while Civica will handle the downstream processes, including drug development, clinical trials, and the production of the final drug product. This partnership aims to bring biosimilars to the US market, leveraging both companies' strengths in biopharmaceutical development and commercialization. In February 2025, Dr. Reddy's collaborated with Shanghai Henlius Biotech (China) to commercialize HLX15 (daratumumab), a biosimilar candidate to Darzalex and Darzalex Faspro, in the US and Europe. Sandoz Group AG (Switzerland) Sandoz Group AG, a prominent player in the biosimilars sector, has strategically concentrated on launching first-to-market products for high-value biologics, exemplified by its offerings Pyzchiva (ustekinumab) and Tyruko (natalizumab). In addition to its commitment to innovative product launches, Sandoz has enhanced its capabilities in manufacturing, technology, and production capacity. A key development in this arena occurred in May 2023, when Sandoz partnered with Just-Evotec Biologics, a CDMO specializing in continuous biomanufacturing; this collaboration develops and manufactures multiple biosimilars, thereby advancing Sandoz's pipeline to a robust total of 24 assets. For more information, Inquire Now!
