other material
confidence high
sentiment positive
materiality 0.85
Crinetics' oral paltusotine succeeds in Phase 3 PATHFNDR-1; 83% maintain IGF-1 vs 4% on placebo
Crinetics Pharmaceuticals, Inc.
- Paltusotine met primary endpoint: 83% maintained IGF-1 ≤1.0xULN vs 4% on placebo (p<0.0001).
- All secondary endpoints met, including GH <1.0 ng/mL (87% vs 28%, p=0.0003) and symptom diary scores.
- No serious or severe adverse events; AE frequency 80% paltusotine vs 100% placebo, fewer acromegaly-related events.
- PATHFNDR-2 (untreated patients) topline data expected Q1 2024; NDA submission planned for 2024.
- Phase 2 study in carcinoid syndrome interim results expected later 2023.