other material
confidence high
sentiment positive
materiality 0.85
Crinetics paltusotine meets all endpoints in Phase 3 acromegaly study; NDA planned 2H 2024
Crinetics Pharmaceuticals, Inc.
- Primary endpoint: 56% of paltusotine patients achieved IGF-1 ≤1.0 xULN vs 5% placebo (p<0.0001).
- All secondary endpoints met: IGF-1 change, GH <1.0 ng/mL, and Acromegaly Symptoms Diary score.
- No serious adverse events reported; common TEAEs included diarrhea, headache, arthralgia, abdominal pain.
- Crinetics to submit NDA to FDA in 2H 2024; potential launch in 2025.
- PATHFNDR-2 enrolled 111 untreated acromegaly patients in a 24-week placebo-controlled trial.