other material
confidence high
sentiment neutral
materiality 0.65
Verastem updates pipeline; PDUFA June 30, 2025 for avutometinib+defactinib in LGSOC
Verastem, Inc.
- PDUFA action date June 30, 2025 for NDA of avutometinib+defactinib in KRAS mutant recurrent LGSOC; launch prep underway.
- RAMP 201 data: 44% ORR in KRAS mt, 31% overall; median PFS 12.9 months; 82% of patients had tumor shrinkage.
- Confirmatory RAMP 301 Phase 3 enrollment on track for completion by end of 2025.
- Filed U.S. IND for VS-7375 (KRAS G12D inhibitor) in Q1 2025; Phase 1/2a initiation expected mid-2025.
- Plan to present RAMP 203 (NSCLC) and RAMP 205 (pancreatic) data at med meetings in H2 2025.