secwatch.observer — SEC 8-K summary
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Issuer:     INSMED Inc (INSM)
CIK:        0001104506
Form:       8-K
Filed at:   2024-07-03T23:59:59+00:00
Accession:  0001140361-24-032333
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Insmed reports additional positive ASPEN data: brensocatib 25 mg slows lung function decline in bronchiectasis
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- Brensocatib 25 mg showed significantly less FEV1 decline vs placebo (38 mL vs -62 mL; p=0.0054) at Week 52.
- Brensocatib 25 mg also showed nominally significant FVC preservation (75 mL less decline; p<0.0001).
- QOL-B Respiratory Symptom Score improved by 3.8 points with 25 mg dose vs placebo (p=0.0004).
- Safety profile favorable; common TEAEs included COVID-19, nasopharyngitis, cough, headache.
- Insmed plans to file NDA in Q4 2024; potential U.S. launch mid-2025, Europe/Japan H1 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1104506/000114036124032333/0001140361-24-032333-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1104506/000114036124032333/ef20031846_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-24-032333

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer