Avutometinib

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 at least one systemic therapy. FDA granted Priority Review, aiming for a decision by June 30, 2025. Verastem prepares for a potential U.S. launch in mid-2025.

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.

B.Riley analyst reaffirms Buy rating for Verastem with a $7.00 target, citing undervaluation and potential of its lead cancer program. Verastem collaborates with GenFleet on a KRAS G12D inhibitor, showing early anti-tumor activity. Despite volatility, Verastem's stock is seen as undervalued, with positive developments in clinical studies and financial performance.

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 Inc. surged 24.8% after FDA approved its New Drug Application for avutometinib with defactinib to treat KRAS mutant recurrent low-grade serous ovarian cancer, setting a PDUFA deadline for June 30, 2025. The treatment, showing promise in Phase 2 RAMP 201 study, addresses an unmet need for 6,000-8,000 U.S. women. Verastem plans a mid-2025 launch, with Breakthrough Therapy and Orphan Drug Designations, and is exploring broader applications in Phase 3 RAMP 301 and a partnership with Amgen for non-small cell lung cancer.

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.