Latest news with #INSM
CNBC
21 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.
Time of India
5 days ago
- Business
- Time of India
US stock market futures steady after 3-day winning streak as Dow, S&P 500, Nasdaq hover near record highs — here are today's biggest premarket movers
U.S. stock market futures are holding steady Thursday morning, pausing after a three-day winning streak that pushed the Dow, S&P 500, and Nasdaq to fresh record territory. Investors are treading carefully ahead of key economic reports that could determine whether the Federal Reserve's rate-cut momentum holds or stalls. Wall Street is catching its breath this morning after a three-day winning streak sent the Dow, S&P 500, and Nasdaq to record highs, with traders now eyeing fresh inflation and jobs data that could decide the Fed's next move. Tired of too many ads? Remove Ads Wall Street takes a breather ahead of PPI and jobless claims Tired of too many ads? Remove Ads Major U.S. Index Levels (Premarket) Dow Jones Industrial Average (DJIA) : 41,285.74, ▲ 0.02% : 41,285.74, ▲ 0.02% S&P 500 : 5,602.38, ▼ 0.01% : 5,602.38, ▼ 0.01% Nasdaq Composite : 18,443.12, ▼ 0.04% : 18,443.12, ▼ 0.04% Russell 2000: 2,124.57, ▲ 0.05% Biggest winners and losers in premarket trading dLocal (DLO) surged +25% after delivering a strong earnings beat. surged after delivering a strong earnings beat. Bullish climbed +14% , continuing its hot streak. climbed , continuing its hot streak. Equinox Gold (EQX) rose +4.6% on stronger commodity sentiment. rose on stronger commodity sentiment. QXO Inc. advanced +3.4% , while Insmed (INSM) , CRISPR Therapeutics (CRSP) , and Cognex (CGNX) each gained more than 2% . advanced , while , , and each gained more than . Tempus AI jumped +7.2% as interest in biotech AI plays picked up. Ibotta (IBTA) plunged −35% after disappointing earnings. plunged after disappointing earnings. Coherent Corp. (COHR) collapsed −19.9% on weak guidance. collapsed on weak guidance. Tapestry Inc. (TPR) tumbled −17% amid a gloomy luxury demand outlook. tumbled amid a gloomy luxury demand outlook. Deere (DE) sank −7.7% after trimming its full-year forecast despite solid demand in some segments. sank after trimming its full-year forecast despite solid demand in some segments. Cisco (CSCO) gave up 0.9% despite posting a modest earnings beat, as investors questioned its growth trajectory. Why the PPI release matters more this time Tired of too many ads? Remove Ads Top movers (percentage gainers) Equinox Gold Corp (EQX) : +4.6% : +4.6% QXO Inc (QXO) : +3.4% : +3.4% Insmed Inc (INSM), CRISPR Therapeutics (CRSP), Cognex Corp (CGNX): each up at least ~2% Coherent Corp (COHR) : –19.9% : –19.9% Tapestry Inc (TPR): –8.4% Broad strength but rotation beneath the surface Why the Fed is in focus today Sector rotation quietly taking shape Strength in homebuilders , financials , biotech , and small caps (Russell 2000 at a six-month high). in , , , and (Russell 2000 at a six-month high). Softness in AI hardware and chip-related names, suggesting investors are locking in profits after a powerful run. The bigger question: Is this a soft landing or a mirage? What to watch in the hours ahead July PPI (8:30 a.m. ET) – Any reading materially above forecasts could dampen September rate cut odds. Weekly jobless claims – Another potential trigger for rate speculation, particularly if filings spike. Treasury market reaction – Yields' direction post-data will signal whether fixed income agrees with equity optimism. Sector leadership – Continued defensive rotation could hint at institutional caution creeping in. Bottom line FAQs: The US stock market took a breather on Thursday, with futures for the Dow Jones Industrial Average, S&P 500, and Nasdaq Composite trading virtually unchanged in early hours. This pause comes after a two-day rally that pushed the S&P 500 and Nasdaq to fresh record closes, fueled by mounting expectations that the Federal Reserve will cut interest rates next of, Dow Jones Industrial Average futures were up roughlyat, while S&P 500 futures inchedto. Nasdaq-100 futures gained just, sitting nearE-mini contracts showed a slightly softer tone, with the S&P 500 mini offatand the Nasdaq-100 mini slippingto, according toThe calm comes as traders brace for theand weekly jobless claims data — two pieces of the inflation and labor puzzle that the Fed watches closely. Sticky price pressures could complicate Wall Street's bet on three quarter-point cuts by year-end, starting in Wednesday's close, the S&P 500 had notched its second straight record, with the Nasdaq following suit. The Dow climbed more than 480 points over two sessions, leaving it within striking distance of its all-time high. Even the often-overlooked— a barometer for small-cap health — hit a six-month peak, suggesting the rally has breadth beyond the mega-cap tech the tone shifted overnight. Futures flattened out as traders adopted a 'wait-and-see' stance ahead of therelease, due at 8:30 a.m. ET. With the market's narrative now laser-focused on interest rate cuts, the inflation read will serve as another test for the Fed's morning's biggest standouts tell a story of sharp divergences across sectors:The PPI tracks wholesale prices and often signals inflationary pressures before they reach consumers. July's reading will come just a day after softer-than-expected CPI data bolstered bets on a September rate cut. According to CME FedWatch, markets are now pricing in a near-80% probability of a 25-basis-point cut, with a small but growing faction speculating on a more aggressive 50-basis-point bolder scenario was floated this week by Treasury Secretary Scott Bessent, who argued that faster action could prevent a sharper slowdown. But San Francisco Fed President Mary Daly poured cold water on the idea, stressing the need for measured steps given persistent uncertainties in wage growth and consumer a trading desk perspective, this divergence between political and central bank voices is creating a subtle volatility undercurrent. The options market, for instance, has seen an uptick in short-dated hedging, a sign some investors fear the Fed may deliver a hawkish surprise despite market notable decliners include:The summer rally hasn't been a one-sector show. Healthcare stocks have emerged as unexpected leaders, with the S&P Health Care Index up nearly 5% month-to-date, outpacing the tech-heavy Nasdaq's gain. Analysts point to defensive rotation — a move into sectors with stable earnings — as a sign some big funds are quietly bracing for choppier waters in the mega-cap techs that drove much of 2023–2024's gains are showing signs of fatigue. Apple (AAPL) and Nvidia (NVDA) both closed slightly lower on Wednesday, even as indexes hit new highs. That kind of divergence often signals a short-term cooling period in speculative risk have fully priced in a, with similar moves expected in October and December. But a hotter-than-expected PPI print could test that Secretaryadded intrigue this week by floating the possibility of a— a move that would likely ignite risk appetite. However, Fed officials likehave urged caution, warning that persistent inflation leaves little room for aggressive the headline numbers, seasoned traders are watching a subtle shift in market leadership:This kind of rotation can often precede new market narratives, especially if rate cuts materialize and smaller, domestically focused stocks start to are split on whether the rally reflects a genuine 'soft landing' — where inflation cools without a recession — or a temporary relief rally ahead of an earnings slowdown. The Fed's Beige Book last week hinted at moderating growth, particularly in manufacturing and commercial real estate, even as consumer spending held bond markets, the 10-year Treasury yield has drifted down to 3.78%, the lowest in nearly six months, reinforcing the view that traders see slower growth ahead. Yet credit spreads remain tight, a sign that Wall Street hasn't fully priced in a downturn portfolio manager I spoke to yesterday put it bluntly: 'We're in a Goldilocks moment — but remember, in the story, Goldilocks gets caught.' It's a reminder that sentiment can flip fast if economic data starts flashing market is standing on the edge of a potentially pivotal data day. A benign PPI print could solidify the September rate cut narrative and extend this week's rally. But a hotter-than-expected number would force traders to reassess just how dovish the Fed can afford to now, the tape is calm, the mood is cautiously optimistic, and all eyes are on 8:30 a.m.A pause in futures trading ahead of key PPI data and Fed rate cut expectations Healthcare and small-caps are showing the strongest momentum.
Malaysian Reserve
7 days ago
- Health
- Malaysian Reserve
FDA Approves BRINSUPRI™ (brensocatib) as the First and Only Treatment for Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease
— Approximately 500,000 U.S. Patients Are Diagnosed with Non-Cystic Fibrosis Bronchiectasis (NCFB), a Progressive Disease That Can Lead to Permanent Lung Damage — — BRINSUPRI 10 mg and 25 mg Doses Approved for the Treatment of NCFB — — BRINSUPRI, a First-in-Class DPP1 Inhibitor Targeting Neutrophilic Inflammation, Is Available by Prescription Through a Comprehensive Specialty Pharmacy Network — — Insmed to Host Investor Conference Call Today at 12:00 PM ET — BRIDGEWATER, N.J., Aug. 12, 2025 /PRNewswire/ — Insmed Incorporated (Nasdaq: INSM), a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved first-in-class BRINSUPRI™ (brensocatib 10 mg and 25 mg tablets), 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, giving hundreds of thousands of patients and clinicians across the U.S. an option to manage this chronic and progressive disease that can lead to permanent lung damage and lung function decline. This press release features multimedia. View the full release here: 'This FDA approval represents a potential paradigm shift in how we approach non-cystic fibrosis bronchiectasis,' said Doreen Addrizzo-Harris, M.D., FCCP, the Fiona and Stanley Druckenmiller Professor of Pulmonary, Critical Care and Sleep Medicine at NYU Grossman School of Medicine and Director of the NYU Langone Health Bronchiectasis and NTM Program, and ASPEN investigator. '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.' There are approximately 500,000 people in the U.S. diagnosed with NCFB, and it is estimated that millions more are living with this disease globally. Unlike other respiratory diseases that are characterized by airway narrowing, bronchiectasis causes airways to permanently widen, making it harder to clear mucus and bacteria, leading to persistent inflammation and infection. A hallmark of bronchiectasis is frequent exacerbations, or flares, when symptoms worsen, such as coughing, increased mucus, shortness of breath and fatigue. 'Non-cystic fibrosis bronchiectasis deeply affects the lives of people living with this chronic lung condition, impacting both their physical health and emotional well-being,' added Elisha Malanga, Executive Director of the Bronchiectasis and NTM Association. 'Many patients experience frequent flares, which can disrupt daily life and potentially lead to disease progression. The FDA approval of brensocatib represents a significant and long-awaited advancement as the first approved therapy for non-cystic fibrosis bronchiectasis. Our hope is that treatments like this will enable people with bronchiectasis to manage their condition.' This approval is based on data from the Phase 3 ASPEN and Phase 2 WILLOW studies, which were both published in the New England Journal of Medicine. In ASPEN, patients taking BRINSUPRI 10 mg or 25 mg had a 21.1% and 19.4% reduction in 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 statistically significant less decline in lung function, as measured by forced expiratory volume in one second (FEV₁) after using a bronchodilator, at week 52. The safety of BRINSUPRI was also evaluated in both studies. The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. 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. 'The FDA approval of the first-ever treatment for non-cystic fibrosis bronchiectasis is a historic milestone for patients and for Insmed,' said Martina Flammer, M.D., MBA, Chief Medical Officer of Insmed. 'By keeping patients at the center of everything we do, we have once again delivered a first-in-class medicine for a disease with no prior approved treatments. This is an incredible achievement in medicine. We're deeply grateful to the patients, providers, and advocates who made this possible – this is just the beginning of what we can accomplish together for this community.' BRINSUPRI is a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor, designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. BRINSUPRI is the first approved therapy to address the underlying inflammatory process of NCFB. 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. BRINSUPRI is now available in the U.S. by prescription through a comprehensive specialty pharmacy network. Conference Call Information Insmed will host a conference call today at 12:00 PM Eastern Time to discuss the FDA approval. The call can be accessed by dialing (888) 210-2654 (U.S. and Canada) or (646) 960-0278 (international) and entering the conference ID number 6364918. The call will also be webcast live on the Company's website at A replay of the conference call will be accessible approximately two hours after its completion through August 19, 2025, by dialing (800) 770-2030 (domestic) or (609) 800-9909 (international) and referencing conference ID number 6364918. A webcast of the call will also be archived for 90 days under the Investor Relations section of the Company's website at About BRINSUPRI™ (brensocatib) BRINSUPRI™ (brensocatib) is a small molecule, once-daily, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1) indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age or older. Brensocatib is designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB. Brensocatib is also being evaluated for its potential role in other neutrophil-mediated diseases. About InLighten Patient Support Program Insmed is committed to providing access to its products by providing eligible patients with financial assistance options. Patients using Insmed products may also enroll to receive ongoing education and support through its inLighten Patient Support Program. About ASPEN ASPEN was a global, randomized, double-blind, placebo-controlled Phase 3 study to assess the efficacy, safety, and tolerability of brensocatib in patients with non-cystic fibrosis bronchiectasis (NCFB). As part of the ASPEN study's conduct, more than 460 trial sites were engaged in nearly 40 countries. After excluding sites that did not enroll any patients and all sites in Ukraine, the total number of active sites in ASPEN was 391 sites in 35 countries. Adult patients (ages 18 to 85 years) were randomized 1:1:1 and adolescent patients (ages 12 to <18 years) were randomized 2:2:1 for treatment with brensocatib 10 mg, brensocatib 25 mg, or placebo once daily for 52 weeks, followed by 4 weeks off treatment. The primary efficacy analysis included data from 1,680 adult patients and 41 adolescent patients. About WILLOW WILLOW was a randomized, double-blind, placebo-controlled, parallel-group, multi-center, multi-national, Phase 2 study to assess the efficacy, safety and tolerability, and pharmacokinetics of brensocatib administered once daily for 24 weeks in patients with non-cystic fibrosis bronchiectasis (NCFB). WILLOW was conducted at 116 sites and enrolled 256 adult patients diagnosed with NCFB who had at least two documented pulmonary exacerbations in the 12 months prior to screening. Patients were randomized 1:1:1 to receive either 10 mg or 25 mg of brensocatib or matching placebo. The primary efficacy endpoint was the time to first pulmonary exacerbation over the 24-week treatment period in the brensocatib arms compared to the placebo arm. About Bronchiectasis Bronchiectasis is a serious, chronic lung disease in which the bronchi become permanently dilated due to a cycle of infection, inflammation, and lung tissue damage. The condition is marked by frequent pulmonary exacerbations requiring antibiotic therapy and/or hospitalizations. Symptoms include chronic cough, excessive sputum production, shortness of breath, and repeated respiratory infections, which can worsen the underlying condition. Most bronchiectasis cases in adults are non-cystic fibrosis bronchiectasis. Today, approximately 500,000 patients in the U.S., 600,000 patients in the EU5 (France, Germany, Italy, Spain, and UK), and 150,000 patients in Japan have been diagnosed with NCFB. Outside the U.S. there are currently no approved therapies specifically targeting bronchiectasis in these regions. IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Dermatologic Adverse Reactions Treatment with BRINSUPRI is associated with an increase in dermatologic adverse reactions, including rash, dry skin, and hyperkeratosis. Monitor patients for development of new rashes or skin conditions and refer patients to a dermatologist for evaluation of new dermatologic findings. Gingival and Periodontal Adverse Reactions Treatment with BRINSUPRI is associated with an increase in gingival and periodontal adverse reactions. Refer patients to dental care services for regular dental checkups while taking BRINSUPRI. Advise patients to perform routine dental hygiene. Live Attenuated Vaccines It is unknown whether administration of live attenuated vaccines during BRINSUPRI treatment will affect the safety or effectiveness of these vaccines. The use of live attenuated vaccines should be avoided in patients receiving BRINSUPRI. ADVERSE REACTIONS The most common adverse reactions ≥2% in the ASPEN trial included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. 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. Less Common Adverse Reactions Liver Function Test Elevations In ASPEN, there was an increase from baseline in average ALT, AST, and alkaline phosphatase levels at all time points from Week 4 through Week 56 in both BRINSUPRI 10 mg and 25 mg arms compared to placebo. The incidence of ALT >3X upper limit of normal (ULN) was 0%, 1.2%, and 0.9%; the incidence of AST >3X ULN was 0.2%, 0.3%, and 0.5%; and the incidence of alkaline phosphatase >1.5X ULN was 2.5%, 4.1%, and 4.0% in patients treated with placebo and BRINSUPRI 10 mg and 25 mg, respectively. Skin Cancers In ASPEN, the incidence of skin cancers among patients treated with BRINSUPRI 10 mg and 25 mg was 0.5% and 1.9%, respectively, compared to 1.1% in placebo-treated patients. Alopecia In ASPEN, the incidence of alopecia among patients treated with BRINSUPRI 10 mg and 25 mg was 1.5% and 1.6% respectively, compared to 0.4% in placebo-treated patients. USE IN SPECIFIC POPULATIONS Pregnancy: There are no clinical data on the use of BRINSUPRI in pregnant women. Lactation: There is no information regarding the presence of BRINSUPRI and/or its metabolite(s) in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for BRINSUPRI and any potential adverse effects on the breastfed child from BRINSUPRI or from the underlying maternal condition. Pediatric use: The safety and effectiveness of BRINSUPRI for the treatment of NCFB have been established in pediatric patients aged 12 years and older. Common adverse reactions in pediatric patients aged 12 years and older enrolled in ASPEN were consistent with those in adults. The safety and effectiveness of BRINSUPRI have not been established in pediatric patients younger than 12 years of age. Please see full Prescribing Information. INDICATION BRINSUPRI is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in adult and pediatric patients 12 years of age and older. About Insmed Insmed Incorporated is a people-first global biopharmaceutical company striving to deliver first- and best-in-class therapies to transform the lives of patients facing serious diseases. The Company is advancing a diverse portfolio of approved and mid- to late-stage investigational medicines as well as cutting-edge drug discovery focused on serving patient communities where the need is greatest. Insmed's most advanced programs are in pulmonary and inflammatory conditions, including two approved therapies to treat chronic, debilitating lung diseases. The Company's early-stage programs encompass a wide range of technologies and modalities, including gene therapy, AI-driven protein engineering, protein manufacturing, RNA end-joining, and synthetic rescue. Headquartered in Bridgewater, New Jersey, Insmed has offices and research locations throughout the United States, Europe, and Japan. Insmed is proud to be recognized as one of the best employers in the biopharmaceutical industry, including spending four consecutive years as the No. 1 Science Top Employer. Visit to learn more or follow us on LinkedIn, Instagram, YouTube, and X. Forward-looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. 'Forward-looking statements,' as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as 'may,' 'will,' 'should,' 'could,' 'would,' 'expects,' 'plans,' 'anticipates,' 'believes,' 'estimates,' 'projects,' 'predicts,' 'intends,' 'potential,' 'continues,' and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements. The forward-looking statements in this press release are based upon the Company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the Company's actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to successfully commercialize BRINSUPRI in the U.S. or to maintain U.S. approval for BRINSUPRI; failure to obtain, or delays in obtaining, regulatory approvals for BRINSUPRI in Europe or Japan, including the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; uncertainties in the degree of market acceptance of BRINSUPRI by physicians, patients, third-party payors and others in the healthcare community; inaccuracies in the Company's estimates of the size of the potential markets for BRINSUPRI or in data the Company has used to identify physicians; expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; the Company's inability to obtain adequate reimbursement from government or third-party payors for BRINSUPRI or acceptable prices for BRINSUPRI; development of unexpected safety or efficacy concerns related to BRINSUPRI, including the risk that data generated in further clinical trials of brensocatib may not be consistent with the results of the ASPEN study, which may result in changes to the product label and may adversely affect sales, or result in withdrawal of BRINSUPRI from the market; failure by us to comply with agreements related to brensocatib, including our license agreement with AstraZeneca AB; failure to successfully conduct future clinical trials for brensocatib, including due to the Company's potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; failure to obtain regulatory approval for potential future brensocatib indications; and failure of third parties on which the Company is dependent to manufacture sufficient quantities of brensocatib for commercial or clinical needs, to conduct the Company's clinical trials, or to comply with the Company's agreements or laws and regulations that impact the Company's business or agreements with the Company. The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company's forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company's business, please see the factors discussed in Item 1A, 'Risk Factors,' in the Company's Annual Report on Form 10-K for the year ended December 31, 2024 and any subsequent Company filings with the Securities and Exchange Commission (SEC). The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The Company disclaims any obligation, except as specifically required by law and the rules of the SEC, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Contact: Investors: Bryan DunnVice President, Investor Relations(732) Media: Claire MulhearnVice President, Corporate Communications(862) 842-6819media@ View original content:
Yahoo
08-08-2025
- Business
- Yahoo
Insmed (INSM) Reports Increased Losses But Reiterates 2025 Revenue Guidance
Insmed recently reported a net loss of $322 million for the second quarter of 2025, yet despite this, its shares surged by nearly 68% over the past quarter. Key factors include Insmed's confirmed guidance for Global ARIKAYCE revenue growth, potentially reflecting investor confidence in future prospects. Additionally, the company's inclusion in multiple Russell indices may have enhanced market visibility and liquidity. Meanwhile, broader market conditions showed significant weekly gains, with major indices rebounding to record highs, which may have generally supported stock performances, including Insmed's, despite its fiscal losses. You should learn about the 2 warning signs we've spotted with Insmed. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. Despite Insmed's recent net loss, a significant share price surge of nearly 68% over the past quarter suggests robust investor confidence in its future prospects, driven by confirmed guidance for Global ARIKAYCE revenue. Over a longer-term horizon of three years, Insmed's total return, including share price and dividends, surged by 308.60%. This substantial growth indicates a strong investor response to the company's pipeline developments and market strategies. Comparatively, Insmed outperformed both the broader US Market and the biotech industry over the past year, where the US Market returned 22.4% and the industry saw a 6.5% decline. The recent news and share price movements could influence Insmed's revenue and earnings forecasts. The upcoming launch of brensocatib in the U.S., combined with the favorable market response to ARIKAYCE, may bolster revenue projections, despite current earnings challenges. With analysts estimating a fair value price target of US$117.29, the current share price of US$109.30 suggests a slight discount. This indicates that investors might see potential in Insmed aligning closely with expected future earnings growth. Dive into the specifics of Insmed here with our thorough balance sheet health report. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include INSM. This article was originally published by Simply Wall St. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Business Insider
17-07-2025
- Business
- Business Insider
Insmed price target raised to $108 from $102 at Morgan Stanley
Morgan Stanley analyst Maxwell Skor raised the firm's price target on Insmed (INSM) to $108 from $102 and keeps an Overweight rating on the shares as part of a Q2 earnings preview. The firm continues to view the potential brensocatib launch favorably. It cites increasing confidence into the potential bronchiectasis launch for the target bump. 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.
