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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.
The headline numbers for Insmed (INSM) give insight into how the company performed in the quarter ended March 2024, but it may be worthwhile to compare some of its key metrics to Wall Street estimates and the year-ago actuals.
Insmed (INSM) came out with a quarterly loss of $1.06 per share versus the Zacks Consensus Estimate of a loss of $1.22. This compares to loss of $1.17 per share a year ago.
Insmed (INSM) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.
BRIDGEWATER, N.J. , May 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 that management will present in a fireside chat at the BofA Securities Health Care Conference 2024 in Las Vegas, NV, on Tuesday, May 14, 2024 at 2:20 p.m.