Latest news with #brensocatib
Yahoo
a day 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.
Yahoo
7 days ago
- 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
Yahoo
18-06-2025
- Business
- Yahoo
Mizuho Reiterates Outperform Rating on Insmed (INSM), Boosts PT to $110
Insmed Inc. (NASDAQ:INSM) is one of the 10 best growth stocks to buy according to billionaires. On June 10, Mizuho analyst Graig Suvannavejh reaffirmed his Outperform rating on Insmed and raised the price target from $96 to $110. The revision follows the encouraging Phase 2b results for Treprostinil Palmitil Inhalation Powder (TPIP) in treating pulmonary arterial hypertension. Suvannavejh describes the data as highly positive, suggesting TPIP could become a leading treatment option in the respective area. A scientist using sophisticated laboratory equipment to analyze a sample of a therapeutic candidate. The analyst believes the trial's success strengthens Insmed's growth outlook and opens the door for further upside to current earnings estimates. The tone of the note reflects the analyst's strong confidence in TPIP's potential and its impact on Insmed's long-term value. Insmed Inc. (NASDAQ:INSM) is a global biopharmaceutical company that develops therapies for serious diseases. It has a commercial product, ARIKAYCE, and a pipeline that includes clinical-stage programs, brensocatib, TPIP, and INS1201, as well as pre-clinical research programs. While we acknowledge the potential of INSM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
Yahoo
18-06-2025
- Business
- Yahoo
Mizuho Reiterates Outperform Rating on Insmed (INSM), Boosts PT to $110
Insmed Inc. (NASDAQ:INSM) is one of the 10 best growth stocks to buy according to billionaires. On June 10, Mizuho analyst Graig Suvannavejh reaffirmed his Outperform rating on Insmed and raised the price target from $96 to $110. The revision follows the encouraging Phase 2b results for Treprostinil Palmitil Inhalation Powder (TPIP) in treating pulmonary arterial hypertension. Suvannavejh describes the data as highly positive, suggesting TPIP could become a leading treatment option in the respective area. A scientist using sophisticated laboratory equipment to analyze a sample of a therapeutic candidate. The analyst believes the trial's success strengthens Insmed's growth outlook and opens the door for further upside to current earnings estimates. The tone of the note reflects the analyst's strong confidence in TPIP's potential and its impact on Insmed's long-term value. Insmed Inc. (NASDAQ:INSM) is a global biopharmaceutical company that develops therapies for serious diseases. It has a commercial product, ARIKAYCE, and a pipeline that includes clinical-stage programs, brensocatib, TPIP, and INS1201, as well as pre-clinical research programs. While we acknowledge the potential of INSM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None. 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
Yahoo
15-06-2025
- Business
- Yahoo
Insmed Incorporated (INSM) Soars on Positive PAH Therapy Trial Results
Insmed Incorporated (NASDAQ:INSM) is among the 10 Best Growth Stocks Under $100 to Buy Now. The shares of Insmed Incorporated (NASDAQ:INSM) have witnessed a surge of about 32% in the course of five days following the success of Phase 2b of its once-daily pulmonary arterial hypertension (PAH) therapy, treprostinil palmitil inhalation powder (TPIP). The results were evaluated about 24 hours after the administration of the drug, showcasing a consistent benefit throughout the 24-hour dosing period. Additionally, the company has revealed plans to initiate discussions with the U.S. Food and Drug Administration (FDA) to shape its Phase 3 trials roadmap. While this first Phase 3 trial will focus on pulmonary hypertension tied to interstitial lung disease by the year's end, the second trial is designed for PAH patients in the coming year. By 2032, the global market for pulmonary arterial hypertension is set to climb to $12.2 billion. A biopharmaceutical research team taking notes in front of a laboratory's microscope. The two anticipated phase 3 studies are enough to be excited about the company, yet there exists another breakthrough. Insmed Incorporated (NASDAQ:INSM) has finalized and submitted its New Drug Application (NDA) of brensocatib for treating patients with Non-cystic fibrosis bronchiectasis (NCFBE), with the date for review set for August 12, 2025. The company is indeed among the companies with high growth potential. Insmed Incorporated (NASDAQ:INSM) is a New Jersey-based biopharmaceutical company that develops and markets therapies to treat patients with serious and rare diseases. With a global presence, the company is committed to transforming the lives of many. While we acknowledge the potential of INSM as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: The Best and Worst Dow Stocks for the Next 12 Months and 10 Unstoppable Stocks That Could Double Your Money. Disclosure: None.
