Moderna stock is 1.7% lower to trade at $147.77 at last check, despite phase three trial data that indicated its combined Covid-19 and flu shot provided NVAX is down 12.4% to trade at $15.91 today, with no specific catalyst to explain the gap lower, and on track for its worst single-session loss since Feb. 28. Thanks to the Sanofi (SNY) deal earlier in May, NVAX is up 226% in 2024. The security fresh off a June 6, 52-week high of $23.85 as well. better protection than its standalone shots. MRNA is up 49.2% ...

BRIDGEWATER, N.J., June 7, 2024 /PRNewswire/ -- Insmed Incorporated (Nasdaq: INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced the granting of inducement awards to 15 new employees. In accordance with NASDAQ Listing Rule 5635(c)(4), the awards were approved by Insmed's Compensation Committee and made as a material inducement to each employee's entry into employment with the Company. In connection with the commencement of ...

BRIDGEWATER, N.J., June 5, 2024 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that management will present in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference in Miami on Monday, June 10, 2024, at 10:00 a.m. ET. The fireside chat will be webcast live and can be accessed by visiting the investor relations section of the Company's website at www.i ...

BRIDGEWATER, N.J., May 30, 2024 /PRNewswire/ -- Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, will host a commercial webinar on Tuesday, June 4, 2024, at 8:00 a.m. ET to discuss the market outlook for the Company's three most advanced programs, ARIKAYCE® (amikacin liposome inhalation suspension), brensocatib, and treprostinil palmitil inhalation powder (TPIP). Shareholders and other interested parties may ...

Currently, there are no medications specifically approved to treat bronchiectasis. Per management estimates, nearly a million patients living in the United States, Europe and Japan are affected by the disease. Based on the results and target market size, Insmed expects to submit a regulatory filing for brensocatib in bronchiectasis in fourth-quarter 2024. If approved, the drug will be the first approved treatment for bronchiectasis patients, with a product launch expected in mid-2025. Management expects to ...

Core Viewpoint - Insmed Incorporated plans to offer and sell $500 million of its common stock in an underwritten public offering, with an option for underwriters to purchase an additional 15% of the shares [1] Company Overview - Insmed Incorporated is a global biopharmaceutical company focused on transforming the lives of patients with serious and rare diseases [5] - The company's first commercial product is a first-in-disease therapy approved in the U.S., Europe, and Japan for a chronic lung disease [5] - Insmed is advancing a pipeline of investigational therapies targeting serious unmet needs, including inflammatory diseases and rare pulmonary disorders [5] - The company is also engaged in early-stage research involving technologies such as artificial intelligence-driven protein engineering and gene therapy [5] Offering Details - The public offering is being conducted under Insmed's shelf registration statement on Form S-3, which became effective on May 19, 2023 [3] - Goldman Sachs & Co. LLC and Leerink Partners are serving as joint book-running managers for the offering [2] - A preliminary prospectus supplement will be filed with the SEC and will be available on the SEC's website [3]

Insmed said that based on these results, it plans to file an application in the fourth quarter with the Food and Drug Administration (FDA) for use of brensocatib in patients with bronchiectasis. It added that pending that approval, it hopes to have the medicine on the market in mid-2025, followed by launches in Europe and Japan in the first half of 2026. Key Takeaways Insmed (INSM) shares more than doubled in value Tuesday after the biopharmaceutical company announced positive results in a late-stage study ...

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Core Viewpoint - Insmed's Phase 3 ASPEN study results for brensocatib in treating non-cystic fibrosis bronchiectasis (NCFB) show significant efficacy, suggesting a promising future for the drug and potential for substantial revenue growth [2][4][5]. Study Results - Brensocatib met its primary endpoint with a 21.1% reduction in annualized pulmonary exacerbations (PEs) at 10 mg and 19.4% at 25 mg compared to placebo, both statistically significant (p<0.01) [3][4]. - Secondary endpoints also showed positive results, including an 18.7% and 17.6% prolongation of time to first PE for the respective dosages, and a 41.2% and 40.0% increase in odds of remaining exacerbation-free weeks [3]. - Safety data indicated a lower incidence of severe treatment-emergent adverse events (TEAEs) in brensocatib patients compared to placebo [4]. Market Potential - NCFB affects approximately 450,000 patients in the U.S. and 400,000 in Europe, with severe cases representing about 20% of the total population [6]. - Peak annual revenue estimates for brensocatib range from $1 billion to $5 billion, with a midpoint estimate of $3 billion considered reasonable [6]. Financial Performance - Insmed reported Q1 2024 revenue of $75.5 million from Arikayce, a 16% annual growth, with an operating loss of $145.5 million [8]. - As of March 31, Insmed had $595.7 million in cash and equivalents, with a current ratio of nearly 2, indicating reasonable short-term liability coverage [9]. Debt and Cash Runway - Insmed's long-term debt totals approximately $939.1 million, necessitating additional capital within the next year due to a cash burn of $184 million in Q1 [10][11]. Investment Outlook - The success of brensocatib in NCFB reduces operational and long-term financial risks, making it a compelling investment opportunity, especially if it can achieve projected peak revenues [12].

Core Insights - Insmed's stock is experiencing a significant rise following positive Phase 3 clinical trial results for brensocatib in patients with non-cystic fibrosis bronchiectasis, achieving its primary endpoint of statistically significant reductions in the annualized rate of pulmonary exacerbations compared to placebo [1][3] - The study also met several secondary endpoints, indicating the potential effectiveness of brensocatib as a treatment option [1][3] Company Developments - Insmed plans to submit a New Drug Application (NDA) for brensocatib to the FDA in Q1 2024, aiming for a commercial launch in mid-2025 [3][4] - Following the NDA submission, the drug is expected to be released in Europe and Japan in 2026 [4] Market Reaction - The stock has seen heavy trading, with over 4.1 million shares traded, significantly above its daily average of approximately 1.8 million shares [4] - As of Tuesday morning, Insmed's stock price has increased by 133.6% [4]