FDA Approval Ahead of PDUFA and Commercial Launch
Received FDA approval for the first treatment specifically for KRAS-mutated recurrent LGSOC nearly two months ahead of the PDUFA date, enabling a commercial launch beginning May 2025.
Initial Product Revenue
Net product revenue of $30.9 million for the launch period (May–Dec 2025) and $17.5 million in Q4 2025, demonstrating early commercial traction.
Rapid Prescriber Adoption and Launch Momentum
Nearly 300 prescribers through February 2026; roughly 60/40 split between GynOncs and MedOncs; ~75% of top target institutions introduced or adopted the CO-PACK; more than half of prescriptions from academic centers, indicating expanding penetration across key accounts.
Strong Payer Coverage and Access Metrics
Payer coverage reported as strong across LGSOC patients regardless of mutation status; typical prior authorization and fill timeline 12–14 days; ~60% of commercially eligible patients using the co-pay program (Verastem Cares).
Clinical Program Enrollment and Milestones
Completed enrollment ahead of schedule in global RAMP 301 (Phase III LGSOC) and RAMP 205 (first-line metastatic pancreatic); RAMP 301 topline primary analysis expected mid-2027, positioning for confirmatory regulatory catalysts.
Positive Early Clinical Signals in Multiple Trials
RAMP 201J (Japan) investigator-assessed ORR: 57% in KRAS-mutant and 22% in KRAS wild-type (n=16). RAMP 205 reported confirmed response in 10 of 12 patients (83% ORR) at ASCO; expansion cohort enrolled with update expected Q2 2026.
VS-7375 Development Progress and Favorable Early Profile
VS-7375 (oral KRAS G12D inhibitor) received IND clearance and Fast Track; first U.S. patient dosed June 2025; U.S. dose escalation cleared to 900 mg QD (evaluating 1200 mg); PK exposures at ≥600 mg comparable to China; emerging U.S. safety profile reportedly better than partner data in China with no drug-related LFT abnormalities or Grade 2 neutropenia reported to date. Preliminary data updates planned H1 and H2 2026.
Cash Position and Runway
Cash, cash equivalents and investments of $205.0 million at Dec 31, 2025 (pro forma $234.4 million after warrant exercises in Jan 2026). Company expects cash runway into the first half of 2027 and believes the LGSOC franchise can be self-sustaining in H2 2026.