Verastem Oncology

Avutometinib/defactinib received FDA priority review for treating recurrent KRAS-mutant low-grade serous ovarian cancer, supported by phase 2 RAMP 201 trial results showing efficacy and safety. The NDA has a Prescription Drug User Fee Act date of June 30, 2025.

The FDA granted priority review to avutometinib combined with defactinib for treating recurrent low-grade serous ovarian cancer with KRAS mutations, targeting a June 30, 2025, decision. Supported by RAMP 201 trial data, the combination showed durable responses and was well tolerated.

Verastem Oncology's shares surged 40.9% after FDA accepted its NDA for avutometinib/defactinib combo therapy for recurrent LGSOC under accelerated approval. The therapy targets LGSOC patients with a KRAS mutation post one systemic therapy. FDA granted Priority Review, expecting a decision by June 30, 2025. Verastem's shares have risen 86.6% in three months.

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 marks a potential first FDA-approved treatment for this rare ovarian cancer, based on promising phase 2 trial results.

Verastem Oncology's NDA for avutometinib and defactinib combo, targeting recurrent KRAS mutant LGSOC, accepted for FDA Priority Review with a June 30, 2025, action date. Based on Phase 2 RAMP 201 trial success, it could be the first FDA-approved treatment for this rare cancer, offering hope for patients with limited options.

Verastem Oncology's NDA for avutometinib plus defactinib, targeting recurrent KRAS mutant LGSOC, received FDA Priority Review with a PDUFA date of June 30, 2025, potentially marking the first FDA-approved treatment for this condition.

Verastem Oncology's FDA filing for avutometinib and defactinib combo targets recurrent KRAS mutant LGSOC, a rare ovarian cancer with no FDA-approved treatments. The Phase 2 RAMP 201 trial showed durable responses and tolerability, supporting the NDA. A Phase 3 trial, RAMP 301, is enrolling patients for further evaluation.

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.