Latest news with #Insmed
CNBC
16 hours ago
- Business
- CNBC
Best Stocks: Rounding out our biotech exposure with a big winner, one we missed and another we're still early on
(This is The Best Stocks in the Market , brought to you by Josh Brown and Sean Russo of Ritholtz Wealth Management.) Josh — One of the primary purposes of keeping this Best Stocks in the Market List is to help us keep our biases in check. For example, my attitude toward the biotechnology segment of the stock market these days can be described as "extreme apathy." I simply do not have time for the names in this group. The industry isn't working, hasn't been working, and has represented a massive opportunity cost versus the major averages over the last few years. But that's just my bias talking. It's informed (I have the data), but it's a bias nonetheless. In the meantime, there is a small number of biotechs on our list, two of which we've written about for CNBC Pro already and one that we should have written up much earlier. You may recall our column from June in which we talked about Gilead Sciences and Alnylam Pharmaceuticals . Both are still included in the Best Stocks list. ALNY has become an incredible winner, up 50% since the day of our write-up. GILD is more of a work in progress, up 5% since in a very tough tape for anything health care. The one we neglected to mention, Insmed (INSM) , is the biggest winner of the three. Sometimes it just works out that way. Sean and I can only cover so many names for you each week. We're trying! In today's update, we'll do an overview of the list and then hit these lonesome three biotech names that have transcended all other stocks in their sector to be among the very best in the U.S. stock market this year. Sector leaderboard As of Aug. 18, there are 182 names on The Best Stocks in the Market list Top sector ranking Top industries Top 5 best stocks by relative strength Sector spotlight Sean — We wrote up a piece on GILD and ALNY in early June. Both stocks are still on the list, and we got another entrant in INSM, rounding out our biotech exposure. Below is the most well-known biotech ETF, which happens to have all 3 of our stocks in its top five holdings: You can see this group of biotechs has ripped off its "liberation day" lows. They just bounced off their 50-day moving average and broke right through their 200-day moving average. The sector is gearing up for a golden cross, assuming we continue trending higher. Biotech stocks have historically shown resilience and even outperformance during Federal Reserve rate-cutting cycles, benefiting from a valuation boost and improved funding conditions (as most capital-intensive businesses do). Because many biotechs generate most of their cash flows in the future, lower interest rates reduce discount rates and increase the present value of those expected earnings. While biotechs generally like rate cuts, the three stocks on our list are in slightly different breakout phases. We were late on Insmed (INSM) You can see this stock is ripping, up 95% over the past three months and up 16% the past week. On Aug. 12, Insmed announced the Food and Drug Administration approved Brensocatib, the first and only treatment specifically for non–cystic fibrosis bronchiectasis, a chronic lung condition. This approval sparked immediate investor enthusiasm, driving the stock higher. Alnylam (ALNY) was a home run We wrote this one up on June 9; the stock is up 48% from that day. Alnylam delivered stellar second-quarter results, far exceeding expectations. Revenues were up 64% year-over-year. The company received regulatory approvals in the European Union, Brazil, UK, Germany and Japan for their cardiomyopathy treatment. We noted the FDA approval in the U.S. as a tailwind for the stock. It's still early for Gilead (GILD) The stock has been trending nicely, up a reasonable 5% since we wrote them up in June. They reported earnings in early August, beating on both lines and raising guidance for the full year. Gross margin improved from 78.7% to 87% and they authorized a new $6 billion share repurchase program along with a 79 cent per share dividend. Risk management Josh — Gilead is the world leader in treating HIV, and its newest approved drug, Yeztugo, got a special shoutout during the earnings call on Aug. 7. Yeztugo is a twice-a-year injection used to prevent HIV, and CEO Daniel O'Day said the first prescription was written within hours of launch — and the first dose was delivered within days. The company is expecting 75% U.S. insurer coverage within six months, and 90% coverage within one year. This, along with other positive developments in the company's pipeline as well as the affirmation of full-year guidance, should support the current rally. GILD found overhead resistance at $120 — precisely where you would have expected it to — as some of those who bought at these levels back in March lighten up just in case the stock fails again. I'm willing to give GILD the benefit of the doubt. I think it trades through $120 and can stay there. Especially if the biotech's long and miserable downtrend is finally being snapped as Sean has shown above. GILD won't give you the maximum bang for your buck in a biotech bull market, but it's been a sector leader and should hold its own. This name has been above its 200-day at all times over the last 12 months (see above). Traders can use $110 for risk management, investors can trail it with a 200-day simple moving average, currently around $102 - I'd keep updating that stop at the end of each week. So long as the sector is in comeback mode and GILD hangs near highs, I'd want to be long. DISCLOSURES: (None) All opinions expressed by the CNBC Pro contributors are solely their opinions and do not reflect the opinions of CNBC, NBC UNIVERSAL, their parent company or affiliates, and may have been previously disseminated by them on television, radio, internet or another medium. THE ABOVE CONTENT IS SUBJECT TO OUR TERMS AND CONDITIONS AND PRIVACY POLICY . THIS CONTENT IS PROVIDED FOR INFORMATIONAL PURPOSES ONLY AND DOES NOT CONSITUTE FINANCIAL, INVESTMENT, TAX OR LEGAL ADVICE OR A RECOMMENDATION TO BUY ANY SECURITY OR OTHER FINANCIAL ASSET. THE CONTENT IS GENERAL IN NATURE AND DOES NOT REFLECT ANY INDIVIDUAL'S UNIQUE PERSONAL CIRCUMSTANCES. THE ABOVE CONTENT MIGHT NOT BE SUITABLE FOR YOUR PARTICULAR CIRCUMSTANCES. BEFORE MAKING ANY FINANCIAL DECISIONS, YOU SHOULD STRONGLY CONSIDER SEEKING ADVICE FROM YOUR OWN FINANCIAL OR INVESTMENT ADVISOR. INVESTING INVOLVES RISK. EXAMPLES OF ANALYSIS CONTAINED IN THIS ARTICLE ARE ONLY EXAMPLES. THE VIEWS AND OPINIONS EXPRESSED ARE THOSE OF THE CONTRIBUTORS AND DO NOT NECESSARILY REFLECT THE OFFICIAL POLICY OR POSITION OF RITHOLTZ WEALTH MANAGEMENT, LLC. JOSH BROWN IS THE CEO OF RITHOLTZ WEALTH MANAGEMENT AND MAY MAINTAIN A SECURITY POSITION IN THE SECURITIES DISCUSSED. ASSUMPTIONS MADE WITHIN THE ANALYSIS ARE NOT REFLECTIVE OF THE POSITION OF RITHOLTZ WEALTH MANAGEMENT, LLC" TO THE END OF OR OUR DISCLOSURE. Click here for the full disclaimer.
Yahoo
5 days ago
- Health
- Yahoo
Insmed wins FDA approval for future blockbuster Brinsupri
Insmed's drug Brinsupri (brensocatib) has landed a double regulatory landmark win, becoming both the first marketed dipeptidyl peptidase 1 (DPP1) inhibitor and the first therapy for non-cystic fibrosis bronchiectasis (NCFB) approved by the US Food and Drug Administration (FDA). Brinsupri has been approved to treat adults and children aged 12 years and over with NCFB. The illness is a form of bronchiectasis not caused by cystic fibrosis, instead with airway damage arising from lung infections or inflammatory disorders, among others. Currently, bronchiectasis is treated through airway clearance procedures, antibiotic treatments, and exercise. However, until now, there has been no therapy specifically approved for the condition. Brinsupri, which is orally taken, is available in 10mg and 25mg tablets. GlobalData pharma analyst Vinie Varkey says: 'Brinsupri represents the first on-label non-antibiotic, anti-inflammatory treatment option that offers a more targeted action and possibly shift away from use of antibiotics in this disease space.' Shares in Nasdaq-listed Insmed closed 7.46% up at market close on 12 August and are currently trading around four times higher compared to a year ago, buoyed by the unveilings of positive clinical data. Brinsupri's approval was based on results from the Phase III ASPEN (NCT04594369) and Phase II WILLOW (NCT03218917) studies. ASPEN, which enrolled more than 1,700 NCFB patients, demonstrated a significant reduction in the annual rate of exacerbations for patients taking the medication. Exacerbations, also known as flare-ups, are endpoints often used in respiratory disease trials to measure therapy efficacy. Patients who received a 10mg dose of Brinsupri had a 21% reduction compared to those on placebo, while those who received a 25mg dose exhibited a 19% reduction. Varkey adds: 'As the first-to-market DPP-1 inhibitor in the respiratory field, Brinsupri is likely to become the standard of care in NCFB treatment. Key opinion leaders interviewed by GlobalData were excited by Brinsupri's ability to reduce exacerbations and slow the rate of lung function decline.' Insmed confirmed that applications for its drug have also been sent to the European Medicines Agency (EMA) and the UK's Medicines and Healthcare products Regulatory Agency (MHRA), with commercial launches anticipated in 2026. Brinsupri is already available in the US by prescription through a comprehensive speciality pharmacy network. The future for Brinsupri is looking bright in its untreaded indication. GlobalData reckons Insemed has a blockbuster on its hands, forecasting sales of $1.7bn by 2033. In an investor presentation, Insmed stated the drug could generate $5bn in peak sales. Around 500,000 people in the US are estimated to have NCFB, according to Insmed. GlobalData forecasts the bronchiectasis market to be worth $3.7bn in 2033 across the 8MM (US, France, Germany, Italy, Spain, UK, Japan, China). GlobalData is the parent company of Pharmaceutical Technology. Brinsupri joins the market alongside Insmed's only other commercial therapy, Arikayce (amikacin), approved in 2018 to treat Mycobacterium avium complex (MAC) lung disease. Varkey adds: 'For Insmed itself, Brinsupri's approval will be one that is instrumental in catapulting the company's profile as a key player within the respiratory space.' Her comments highlight an opportunity for DPP-1 inhibitors to expand into other respiratory indications, highlighting further growth avenues for biopharmas. "Insmed wins FDA approval for future blockbuster Brinsupri" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
UPI
6 days ago
- Health
- UPI
First drug to treat bronchiectasis lung condition approved by FDA
The U.S. Food and Drug Administration has approved Insmed's daily bronchiectasis pill, brensocatib, which will be sold under the brand name Brinsupri. File Photo by John Angelillo/UPI | License Photo For the first time, people with bronchiectasis will have a treatment option. The U.S. Food and Drug Administration has approved Insmed's daily pill brensocatib, which will be sold under the brand name Brinsupri. The drug is designed to treat non-cystic fibrosis bronchiectasis, a chronic condition that damages the lungs and makes it harder to clear mucus, the company said in a statement. The approval comes after the medication succeeded in one of last year's most closely watched Phase 3 clinical trials. The company says Brinsupri could become a blockbuster, estimating peak sales at $5 billion a year, STAT News reported. "The FDA approval of the first-ever treatment for non-cystic fibrosis bronchiectasis is a historic milestone for patients and for Insmed," the company's chief medical officer, Dr. Martina Flammer, said in a statement. The American Lung Association estimates that bronchiectasis affects between 350,000 and 500,000 adults in the United States. It happens when the airways in the lungs become widened, thickened and scarred - often after an infection or other damage. This makes it difficult to clear mucus, allowing germs and particles to build up and cause repeated lung infections. Brinsupri works by blocking an enzyme called DPP1. Insmed bought the drug from AstraZeneca for $30 million and is also testing it for other conditions, such as chronic rhinosinusitis, STAT News reported. The company plans to sell the drug in the U.S. at an annual list price of $88,000. It has also filed for approval in Europe and the United Kingdom, and it plans to do so in Japan. "For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses a root cause of bronchiectasis exacerbations. Based on the strength of the data and the impact we've seen in patients, I believe this could become the new standard in non-cystic fibrosis bronchiectasis care." Dr. Doreen Addrizzo-Harris, a pulmonary and critical care physician and director of the NYU Langone Health Bronchiectasis and NTM Program in New York City, said in a news release. More information The American Lung Association has more about bronchiectasis. Copyright © 2025 HealthDay. All rights reserved.
Business Insider
6 days ago
- Business
- Business Insider
Analysts Have Conflicting Sentiments on These Healthcare Companies: ProKidney (PROK), Oric Pharmaceuticals (ORIC) and Insmed (INSM)
Companies in the Healthcare sector have received a lot of coverage today as analysts weigh in on ProKidney (PROK – Research Report), Oric Pharmaceuticals (ORIC – Research Report) and Insmed (INSM – Research Report). 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. ProKidney (PROK) In a report released yesterday, Jason Gerberry from Bank of America Securities maintained a Sell rating on ProKidney, with a price target of $1.00. The company's shares closed last Tuesday at $2.24. According to Gerberry is a 3-star analyst with an average return of 2.5% and a 48.6% success rate. Gerberry covers the Healthcare sector, focusing on stocks such as Amphastar Pharmaceuticals, BioMarin Pharmaceutical, and Tarsus Pharmaceuticals. ProKidney has an analyst consensus of Moderate Buy, with a price target consensus of $5.60. Oric Pharmaceuticals (ORIC) In a report released yesterday, Anupam Rama from J.P. Morgan maintained a Buy rating on Oric Pharmaceuticals. The company's shares closed last Tuesday at $9.52. According to Rama has currently 0 stars on a ranking scale of 0-5 stars, with an average return of -6.4% and a 39.3% success rate. Rama covers the Healthcare sector, focusing on stocks such as Day One Biopharmaceuticals, Ultragenyx Pharmaceutical, and Maze Therapeutics, Inc. Oric Pharmaceuticals has an analyst consensus of Strong Buy, with a price target consensus of $17.67. Insmed (INSM) In a report released yesterday, Jessica Fye from J.P. Morgan maintained a Buy rating on Insmed. The company's shares closed last Tuesday at $122.00. According to Fye is a 4-star analyst with an average return of 7.7% and a 53.8% success rate. Fye covers the Healthcare sector, focusing on stocks such as BioMarin Pharmaceutical, Vertex Pharmaceuticals, and Ionis Pharmaceuticals. Insmed has an analyst consensus of Strong Buy, with a price target consensus of $127.94, implying a 13.3% upside from current levels. In a report issued on August 7, Mizuho Securities also maintained a Buy rating on the stock with a $111.26 price target.
Yahoo
7 days ago
- Business
- Yahoo
FDA Approves Insmed's Drug As First Treatment For Type Of Chronic Lung Disease
The U.S. Food and Drug Administration (FDA) on Tuesday approved Insmed Incorporated's (NASDAQ:INSM) Brinsupri (brensocatib 10 mg and 25 mg tablets). It is an oral, once-daily treatment for non-cystic fibrosis bronchiectasis (NCFB) in adults and children 12 years and older. Brinsupri is the first and only FDA-approved treatment for NCFB, a chronic lung condition characterized by permanently widened and damaged airways (bronchi), leading to persistent mucus production, recurrent infections, and difficulty breathing. There are approximately 500,000 people in the U.S. diagnosed with NCFB. The approval is based on data from the Phase 3 ASPEN and Phase 2 WILLOW ASPEN, patients taking Brinsupri 10 mg or 25 mg had a 21.1% and 19.4% reduction in the annual rate of exacerbations, respectively, as compared to placebo. Both dosage strengths of Brinsupri also met several exacerbation-related secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period. Patients who received Brinsupri 25 mg experienced a statistically significantly less decline in lung function, as measured by forced expiratory volume in one second (FEV₁) after using a bronchodilator, at week 52. The safety profile for adult patients with NCFB in WILLOW was generally similar to ASPEN, except for a higher incidence of gingival and periodontal adverse reactions in WILLOW. In parallel, applications for brensocatib with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have been accepted, and the company plans to file in Japan in 2025. Commercial launches are anticipated in 2026, pending approval in each territory. Price Action: INSM stock is up 6.20% at $119.89 at the last check on Tuesday. Read Next:Photo: Shutterstock UNLOCKED: 5 NEW TRADES EVERY WEEK. Click now to get top trade ideas daily, plus unlimited access to cutting-edge tools and strategies to gain an edge in the markets. Get the latest stock analysis from Benzinga? INSMED (INSM): Free Stock Analysis Report This article FDA Approves Insmed's Drug As First Treatment For Type Of Chronic Lung Disease originally appeared on © 2025 Benzinga does not provide investment advice. All rights reserved. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
