secwatch.observer — SEC 8-K summary
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Issuer:     INSMED Inc (INSM)
CIK:        0001104506
Form:       8-K
Filed at:   2024-05-28T23:59:59+00:00
Accession:  0001140361-24-027535
Event type: other_material
Sentiment:  positive
Materiality: 1.00
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Insmed Announces Positive Topline Results from Phase 3 ASPEN Study of Brensocatib in Bronchiectasis
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- ASPEN Phase 3 met primary endpoint: brensocatib 10mg and 25mg reduced annualized pulmonary exacerbations by 21.1% (p=0.0019) and 19.4% (p=0.0046) vs placebo.
- Brensocatib achieved statistical significance on multiple secondary endpoints including prolongation of time to first PE and odds of remaining exacerbation-free.
- Insmed plans to file NDA with FDA in Q4 2024; anticipates U.S. launch mid-2025, Europe/Japan launches first half 2026.
- If approved, brensocatib would be first approved treatment for bronchiectasis and first DPP1 inhibitor for neutrophil-mediated diseases.
- Brensocatib well-tolerated; severe TEAEs occurred in 12.7% (10mg), 11.7% (25mg), and 16.0% (placebo) with lower serious TEAE rates than placebo.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1104506/000114036124027535/0001140361-24-027535-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1104506/000114036124027535/ef20030032_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-24-027535

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