secwatch.observer — SEC 8-K summary
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Issuer:     INSMED Inc (INSM)
CIK:        0001104506
Form:       8-K
Filed at:   2025-06-10T23:59:59+00:00
Accession:  0001140361-25-022023
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Insmed TPIP Phase 2b in PAH meets primary endpoint with 35% PVR reduction (p<0.001)
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- Placebo-adjusted PVR reduction 35% (p<0.001); 6MWD improvement 35.5 m (p=0.003); NT-proBNP reduction 60% (p<0.001).
- Once-daily TPIP well tolerated; 75% of patients titrated to max dose 640 µg; 90% completed study.
- Insmed to engage FDA for Phase 3; PH-ILD Phase 3 by end 2025; PAH Phase 3 early 2026.
- Common TEAEs: cough 40.6%, headache 31.9%, fatigue 10.1%; no deaths in study.
- 95% of completers enrolled in open-label extension (1,280 µg max dose allowed).

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1104506/000114036125022023/0001140361-25-022023-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1104506/000114036125022023/ef20050418_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-25-022023

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