Verastem Oncology

Verastem Oncology's stock surged over 40% after FDA accepted its NDA for Avutometinib and Defactinib combo for recurrent KRAS mutant LGSOC, with a decision by June 30, 2025. This could be the first FDA-approved treatment for this rare ovarian cancer.

Verastem Oncology's NDA for avutometinib and defactinib, targeting recurrent KRAS mutant LGSOC, received FDA Priority Review with a PDUFA date of June 30, 2025. This combination could be the first FDA-approved treatment for this specific cancer type.

Verastem Oncology's NDA for avutometinib plus defactinib for recurrent KRAS mutant LGSOC received FDA Priority Review, with a PDUFA date of June 30, 2025. This combination, showing promise in Phase 2 trials, could be the first FDA-approved treatment for this rare ovarian cancer.

Verastem Oncology's treatment for recurrent low-grade serous ovarian cancer, combining avutometinib and defactinib, received FDA priority review. A decision is expected by June 30, 2025, potentially marking the first specific treatment for this cancer type. Shares surged 21% post-announcement.

Verastem Oncology's treatment for recurrent low-grade serous ovarian cancer (LGSOC) received FDA priority review. The therapy combines avutometinib and defactinib, targeting patients with a KRAS mutation. LGSOC, affecting thousands globally, lacks FDA-approved specific treatments, with current options being hormone therapy and chemotherapy.

Verastem Oncology's NDA for avutometinib with defactinib, targeting recurrent KRAS mutant LGSOC, received FDA Priority Review with a PDUFA date of June 30, 2025. Based on Phase 2 RAMP 201 trial results, it could be the first FDA-approved treatment for this condition.

Verastem Oncology's treatment for recurrent low-grade serous ovarian cancer (LGSOC) with a KRAS mutation, combining avutometinib and defactinib, received FDA priority review. Shares surged nearly 20%. LGSOC affects 6,000-8,000 U.S. women, is recurrent, less chemo-sensitive, and lacks FDA-approved therapies.

Verastem Oncology's NDA for avutometinib and defactinib combo for recurrent LGSOC with KRAS mutation was accepted by FDA under Priority Review, with a PDUFA date of June 30, 2025. Based on Phase 2 RAMP 201 trial results, showing durable responses and good tolerability, it aims to address a current treatment gap. A Phase 3 trial, RAMP 301, is enrolling patients for further confirmation.

Verastem Oncology reports no dose-limiting toxicities in RAMP 203 Phase 1/2 study of avutometinib, sotorasib, and defactinib for KRAS G12C mutant NSCLC. Two of three patients showed initial tumor reductions of at least 20%. Enrollment continues, with an interim update planned for 2025.

The NDA for avutometinib and defactinib in recurrent KRAS mutant LGSOC is complete, aiming for FDA approval in mid-2025. This combination could be the first FDA-approved treatment for this rare, fatal ovarian cancer.