Form 8-K · Current Report · Filed 2024-05-28
Insmed Announces Positive Topline Results from ASPEN Study of Brensocatib in Bronchiectasis Patients
On May 28, 2024, Insmed Incorporated announced positive topline results from its Phase 3 ASPEN study of brensocatib in non-cystic fibrosis bronchiectasis patients.
- Filer
- Insmed Inc. INSM · NASDAQ
- Filed
- Accession
- 0001140361-24-027535
- CIK
- 0001104506
- Signal
- Low impactHealthcare
- Source
- Official filing on sec.gov ↗
Details
Both dosage strengths of brensocatib demonstrated statistically significant reductions in annualized pulmonary exacerbations (PEs) compared to placebo. The study also met several secondary endpoints. Based on these results, Insmed plans to file a New Drug Application with the FDA in the fourth quarter of 2024. Pending approvals, the company anticipates a U.S. launch in mid-2025 followed by launches in Europe and Japan in the first half of 2026. The announcement also includes details of an upcoming investor call and presentation.
Items reported
Regulation FD Disclosure
Other Events
Financial Statements and Exhibits
Market reaction
Close before filing
$22.00
Next session
+143.4%
Since filing
+348.2%
Latest close
$98.60
What happened, not what will happen — closing prices around the filing date.
Precedent
Previous filings from INSM reporting the same item, with the next session's move:
Exhibits (2)
About Insmed Inc.
Insmed Inc. is a biopharmaceutical company dedicated to enhancing the lives of patients with rare diseases. The company's primary focus is on the development and commercialization of treatments for serious and rare disorders, particularly in the fields of pulmonology and infectious diseases. One of Insmed's noteworthy products is Arikayce, an inhaled antibiotic that addresses specific pulmonary infections often affecting patients with underlying lung conditions. Insmed Inc. also undertakes robust research and development efforts to boost its pipeline of potential therapies, aiming to address unmet medical needs. Operating within the broader healthcare sector, Insmed is a key player in the biopharmaceutical landscape, driven by innovation and scientific research. The company’s continued advancements and strategic collaborations underscore its commitment to elevating patient care and expanding treatment options for rare disease patients. This aligns Insmed as a significant entity in the realm of specialized healthcare solutions, reflecting its impact on the biopharmaceutical market.
Never miss another INSM filing
Profitelligence watches EDGAR around the clock and alerts you within seconds.