FDA accepted Verastem Oncology's NDA for avutometinib with defactinib for recurrent LGSOC with KRAS mutation, granting Priority Review. Based on Phase 2 RAMP 201 trial, showing durable responses and tolerability. Phase 3 RAMP 301 trial ongoing for broader LGSOC indication. VSTM stock rose 26.4%.
Verastem Oncology's stock surged over 40% to $5.17 after the FDA accepted its New Drug Application for Avutometinib combined with Defactinib for treating recurrent KRAS mutant low-grade serous ovarian cancer, with a decision by June 30, 2025. This potential first-ever FDA-approved treatment for the condition showed promising phase II trial results.
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 (VSTM) stock surged 20% after-hours as the FDA accepted its New Drug Application for priority review of avutometinib and defactinib for ovarian cancer treatment.
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.