other_material
confidence high
sentiment positive
materiality 0.85
Insmed TPIP Phase 2b in PAH meets primary endpoint with 35% PVR reduction (p<0.001)
INSMED Inc
- 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).
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