other material
confidence high
sentiment positive
materiality 0.80
Verastem outlines 2024 priorities: NDA submission for avutometinib/defactinib in LGSOC in H1 2024
Verastem, Inc.
- Plans to begin rolling NDA submission for accelerated approval of avutometinib/defactinib in recurrent LGSOC in H1 2024; potential commercial launch in 2025.
- Initial data from RAMP 205 trial of avutometinib/defactinib plus chemo in frontline metastatic pancreatic cancer expected H1 2024.
- Data from RAMP 203 and RAMP 204 trials in KRAS G12C-mutant NSCLC planned for mid-2024.
- Interim RAMP 201 results showed ORR 45% (13/29) and disease control 86% (25/29) in LGSOC; Phase 3 RAMP 301 initiated.
- Collaborator GenFleet to advance oral KRAS G12D inhibitor GFH375/VS-7375 into Phase 1 in 2024.