Verastem (VSTM) Company Overview

Verastem, Inc.'s NDA for avutometinib and defactinib in recurrent KRAS-mutant LGSOC has been accepted by the FDA, with a PDUFA date set for June 30, 2025. The combination therapy shows promising Phase II RAMP 201 results, with a 31% ORR and significant tumor size reduction, potentially positioning Verastem as a commercial-stage company by 2025. The LGSOC market is projected to reach $363.7M by 2034, with Verastem's therapy poised to capture a significant share due to the lack of approved treatments.

Verastem, Inc. is on the verge of FDA approval for their combo therapy avutometinib-defactinib, targeting low-grade serous ovarian carcinoma. Financially, VSTM has limited cash reserves, with only 4-5 quarters of operating funds, posing a risk if there are approval delays. The market size for their therapy is uncertain, with potential revenues ranging from $85.7 million to $686 million annually.

The FDA accepts Verastem's NDA for the accelerated approval of avutometinib to treat recurrent KRAS mutant ovarian cancer under priority review. The stock rises 41%.

BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) under the accelerated approval pathway for avutometinib, an oral RAF/MEK clamp, in combination with defactinib, an oral FAK inhibitor, for the treatment of adult patients with recurrent low-grade serous ovarian cancer (LGSOC), wh.

BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced preliminary clinical data for the triplet combination of avutometinib and sotorasib plus defactinib in the RAMP 203 Phase 1/2 study in KRAS G12C mutant advanced non-small cell lung cancer (NSCLC). No dose-limiting toxicities (DLTs) have been observed in the triplet combination. RAMP 203 continues to progress, with additional enroll.

Verastem's avutometinib and defactinib show promising clinical progress for recurrent KRAS-mutant LGSOC, with potential FDA approval and market launch by mid-2025. The company's strong cash position and strategic focus on RAS-driven cancers offer significant growth opportunities without imminent dilution risks. Upcoming catalysts include FDA filing decisions, interim data from NSCLC and pancreatic cancer trials, and potential commercial launch, driving Verastem's bullish outlook.

BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced updated data from the Phase 2 RAMP 201 (ENGOTov60/GOG3052) clinical trial evaluating the combination of avutometinib, an oral RAF/MEK clamp, and defactinib, an oral, selective FAK inhibitor, in patients with recurrent low-grade serous ovarian cancer (LGSOC). The data were published as a late-breaking abstract and additional detaile.

BOSTON--(BUSINESS WIRE)--Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced further details for its late-breaking presentation of mature data from the ongoing Phase 2 RAMP 201 (ENGOT-ov60/GOG-3052) clinical trial to be presented as an oral presentation at a plenary session at the International Gynecologic Cancer Society (IGCS) Annual Global Meeting taking place October 16-18, 2024 in Dublin, Ireland. The l.

Verastem's Avutometinib and Defactinib combination therapy targets recurrent LGSOC and is expected to complete its rolling NDA by 2H2024. The company has a diverse pipeline, exploring treatments for metastatic pancreatic cancer and mKRAS G12C non-small cell lung cancer (NSCLC). Interim results for Avutometinib + Defactinib show a 45% ORR overall and 60% ORR for KRAS-mutant patients, with tumor regression in 86%.