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Insmed Incorporated (INSM) Rallies After FDA Approves Brinsupri, Shares Jump 9%
Yahoo Finance· 2025-09-30 16:32
We recently compiled a list of the 12 Best Performing Healthcare Stocks to Buy Right Now. Insmed Incorporated is one of them. Insmed Incorporated (NASDAQ:INSM) tops our list for being one of the best performing stocks. It is a biopharmaceutical company focused on rare diseases, with a portfolio targeting serious conditions with unmet medical needs. Its flagship product, ARIKAYCE® (amikacin liposome inhalation suspension), addresses lung infections and has shown strong market growth. Recently, INSM gained ...
Insmed Incorporated (INSM) Presents At Morgan Stanley 23rd Annual Global Healthcare Conference Transcript
Seeking Alpha· 2025-09-10 16:10
Core Insights - Insmed has experienced significant growth, with its market value increasing from approximately $3 billion to $30 billion over the last 18 months, driven by three main product franchises [3] - The three key products are ARIKAYCE for refractory MAC lung disease, Brinsupri (formerly brensocatib) for bronchiectasis, and TPIP for pulmonary hypertension, each targeting multiple indications [3][4] - The company holds a diversified product portfolio with multibillion-dollar potential for each of its three main compounds, positioning it favorably in the biotech industry [4]
Lung Disease-Focused Insmed 'Must-Own' Name For Investors
Benzinga· 2025-08-20 18:46
Core Viewpoint - William Blair initiated coverage on Insmed Incorporated, emphasizing the potential for significant valuation increase due to the clinical and commercial execution of its drugs, particularly Brinsupri [1] Group 1: Product Approval and Market Potential - The FDA approved Insmed's Brinsupri as an oral, once-daily treatment for non-cystic fibrosis bronchiectasis in adults and children aged 12 and older [2] - Brinsupri is the first and only FDA-approved treatment for non-cystic fibrosis bronchiectasis, a chronic lung condition that leads to persistent mucus production and difficulty breathing [3] Group 2: Clinical Trial Results - The Phase 2b study of treprostinil palmitil inhalation powder (TPIP) for pulmonary arterial hypertension met its primary endpoint, showing a placebo-adjusted reduction in pulmonary vascular resistance of 35% [4] Group 3: Financial Projections and Valuation - Insmed's peak sales potential could approach $15 billion by 2035, supported by upcoming trial readouts for Brinsupri, Arikayce, and TPIP [4] - The strong initial launch of Brinsupri is expected to command a valuation of roughly five times the five-year sales forecasts, with an estimated revenue of $7.7 billion by 2031 [6] - Insmed's stock is currently up 1.84% at $129.55, reflecting investor confidence in its market opportunities [6] Group 4: Strategic Outlook - William Blair sees Insmed evolving into a leading large-cap biotech, with strong value in its sizable market opportunities and de-risked clinical programs [5]
以诺康启动上市辅导;绿谷971再注册申请未获批准
Policy Developments - Shanghai has initiated the online listing for the first batch of traditional Chinese medicine centralized procurement expansion, with the application period from August 12 to August 29, 2025 [1] Drug and Device Approvals - Hualan Vaccine has received approval for clinical trials of its lyophilized Hib conjugate vaccine, which is expected to induce immune response against Hib [2] - Insmed announced that the FDA has approved its first-in-class oral drug Brinsupri for treating non-cystic fibrosis bronchiectasis in patients aged 12 and older [3] - The National Medical Products Administration has received a market application for the intraocular injection of Bevacizumab from Fuhong Hanlin and Eddingpharm, marking the second such application in China [4] - Heng Rui Medicine has received approval for clinical trials of its innovative drug SHR-A2102 in combination with other treatments for recurrent/metastatic head and neck squamous cell carcinoma [5] Capital Market Activities - Inokang Medical Technology has started the listing guidance process with Huatai Securities, as disclosed by the China Securities Regulatory Commission [6] - Inokang was founded in 2014 by returnees and experienced professionals in the medical industry, and it has been recognized as a national high-tech enterprise [7] - Rejuve Bio announced a capital increase of 100 million yuan for its subsidiary ShunJing Biomedical Technology, with the company's stake decreasing from 45.5833% to 43.1842% [8] Industry Events - Zhifei Biological has completed the first nationwide vaccination of its quadrivalent influenza vaccine, highlighting the competitive landscape and market potential in China's influenza vaccine sector [10] - Zhonghui Bio's quadrivalent influenza vaccine has passed the preliminary review for inclusion in the national commercial health insurance innovative drug directory [11] - BeiGene anticipates that its drug Sotucumab will receive its first global approval by the end of 2026, with multiple milestone events expected soon [12] Public Sentiment Alerts - The re-registration application for Green Valley Pharmaceutical's mannitol sodium capsules has not been approved, indicating ongoing challenges for this controversial Alzheimer's drug [14] Shareholder Activities - Former Vice Chairman of Zhaoyan New Drug plans to reduce his holdings by up to 352.45 million shares due to personal financial needs, representing 0.4703% of the company's total share capital [15]
Insmed (INSM) FDA Announcement Transcript
2025-08-12 17:02
Summary of Insmed's Conference Call on FDA Approval of Brensocatib Company and Industry - **Company**: Insmed (INSM) - **Industry**: Pharmaceutical, specifically focusing on treatments for respiratory diseases Key Points and Arguments 1. **FDA Approval Announcement**: Insmed announced the FDA approval of brensocatib for patients with non-cystic fibrosis bronchiectasis (NCFB), marking a significant milestone as it is the first approved treatment for this condition in over 200 years [2][4][5] 2. **Product Details**: Brensocatib will be marketed under the brand name Brinsupri, available in 10 mg and 25 mg tablet forms, with an annual list price of $88,000 [6][7][8] 3. **Sales Strategy**: Insmed's sales force has built relationships with approximately 27,000 pulmonologists to facilitate a smooth launch. The company expects a gross-to-net discount of 25% to 35% at launch [6][7][8][51] 4. **Market Potential**: The company anticipates global peak sales of over $5 billion for brensocatib in the NCFB indication alone, with the potential to serve an additional 500,000 patients in the U.S. [8][14] 5. **Patient Demographics**: Insmed estimates that about 250,000 patients diagnosed with NCFB will be eligible for treatment at launch, with many more expected to be diagnosed as awareness increases [70][72] 6. **Clinical Data**: The approval label includes significant benefits on FEV1, a key measure of lung function, and reflects the safety profile observed during clinical trials [11][12] 7. **Payer Engagement**: Insmed is negotiating with payers to ensure that the attestation process for prior exacerbations is streamlined, aiming to avoid burdensome documentation requirements [33][79] 8. **Future Studies**: Insmed is exploring the potential of brensocatib in other neutrophil-mediated diseases, with ongoing studies expected to yield results in the coming year [75][76] Other Important but Possibly Overlooked Content 1. **Historical Context**: The approval of brensocatib is significant as it is the first treatment for bronchiectasis, a condition recognized since 1819, highlighting the long-standing need for effective therapies [5][14] 2. **Shelf Life and Inventory**: Brensocatib has a 24-month shelf life, allowing Insmed to utilize existing inventory effectively [12] 3. **Seasonality Factors**: There are seasonal considerations for patient flow, particularly related to viral infections that can trigger exacerbations [46] 4. **Sales Metrics**: Insmed plans to provide quarterly updates on sales results, new patient starts, and cumulative prescribers until annual sales guidance is issued [8][60] 5. **Physician Engagement**: Over 90% of surveyed physicians indicated a willingness to prescribe brensocatib, suggesting strong initial uptake [64][66] This summary encapsulates the critical aspects of Insmed's conference call regarding the FDA approval of brensocatib, emphasizing the company's strategic positioning, market potential, and future directions in research and patient engagement.