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Insmed Incorporated (NASDAQ:INSM) shares more than doubled after the company released positive results from its late-stage study of its experimental therapy brensocatib for a lung condition. The company said patients in the study with non-cystic fibrosis bronchiectasis who were dosed with brensocatib saw statistically significant reductions in the annualized rate of pulmonary exacerbations compared to placebo.
Brensocatib, Insmed's DPP1 inhibitor, showed significant efficacy in the Phase 3 ASPEN study for treating NCFB. Insmed's financial position includes high R&D costs with a solid short-term liquidity ratio but substantial long-term debt. Peak revenue estimates for brensocatib range from $1-5 billion, with a reasonable midpoint of $3 billion expected.
Insmed stock catapulted Tuesday after the biotech company experimental lung disease treatment succeeded in a final-phase study.
Insmed (NASDAQ: INSM ) stock is rising higher on Tuesday after the company announced positive results from a Phase 3 clinical trial of brensocatib in patients with non-cystic fibrosis bronchiectasis. This saw brensocatib reach its primary endpoint of statistically significant reductions in the annualized rate of pulmonary exacerbations (PEs) versus placebo.
Shares of Insmed Inc. skyrocketed Tuesday, after the biopharmaceutical company said it plans to file a New Drug Application for its treatment of non-cystic fibrosis bronchiectasis following positive Phase 3 trial results.
Insmed said its experimental drug to treat a type of chronic lung disease helped significantly reduce respiratory symptoms such as chronic cough in a late-stage study, prompting its shares to double in premarket trading on Tuesday.
—Phase 3 Study Achieves Primary Endpoint for Both Dosage Strengths of Brensocatib with Statistically Significant and Clinically Meaningful Reduction in Frequency of Pulmonary Exacerbations Versus Placebo— —Treatment with Brensocatib Also Achieves Statistical Significance on Multiple Secondary Endpoints for Both Dosage Strengths Versus Placebo— —Brensocatib Well-Tolerated at Both Dosage Strengths— —Results from ASPEN Validate DPP1 Inhibition as New Mechanism of Action with Potential to Address Range of Neutrophil-Mediated Diseases— —Insmed Plans to Advance Quickly Toward U.S. Regulatory Filing, with Anticipated U.S. Launch in Mid-2025, Pending Approval— —Insmed to Host Investor Call at 8:00 am ET on Tuesday, May 28, 2024— BRIDGEWATER, N.J. , May 28, 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 positive topline results from
—Conference Call to Take Place Tomorrow, Tuesday, May 28, 2024, at 8:00 am ET— BRIDGEWATER, N.J. , May 27, 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 it will host a conference call and webcast tomorrow, Tuesday, May 28, 2024, at 8:00 am ET to discuss topline results from the ASPEN study, 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.
—Patients Treated with ARIKAYCE Plus Macrolide-Based Background Regimen Had Meaningfully Greater Improvements in Respiratory Symptoms vs. Macrolide-Based Background Regimen Alone, As Measured By the QOL-B Respiratory Domain Instrument— — QOL-B Respiratory Domain Scores for ARIKAYCE Patients Showed Improvement Through Month 6 and Continued to Improve Through Month 7 (1 Month Off Treatment), While Improvements in the Comparator Arm Plateaued After Month 3 and Worsened After Month 6 — —Microbiologic Data Presented Showed Patients in the ARIKAYCE-treated Arm Had Numerically Greater Rates of Culture Conversion By Month 6, and Nominally Statistically Significantly Higher Rates By Month 7, With Earlier Time to First Culture Conversion vs.
Insmed (INSM) Q1 earnings beat estimates while sales miss the mark. Management posts positive data readouts from mid-stage studies on its experimental inhalation powder in PH-ILD and PAH indications.