NASDAQ — Healthcare: Manufacturing, Biotechnology: Pharmaceutical Preparations
www.verastem.comThe FDA has set a Prescription Drug User Fee Act action date of June 30, 2025, for Verastem, Inc.'s New Drug Application seeking accelerated approval for the combination of avutometinib, a RAF/MEK clamp, and defactinib, a FAK inhibitor, to treat adult patients with recurrent low-grade serous ovarian carcinoma (LGSOC) with a KRAS mutation who have received at least one prior systemic therapy. The NDA was completed in October 2024 and is currently under Priority Review by the FDA.
Prescription Drug User Fee Act Action DateThe FDA has set a Prescription Drug User Fee Act action date for the New Drug Application for Verastem, Inc.'s avutometinib and defactinib combination therapy to June 30, 2025. The drugs are designed for the treatment of adult patients with recurrent low-grade serous ovarian carcinoma who have a KRAS mutation.
PDUFA Action DateA clinical trial involving pembrolizumab and defactinib for patients with advanced pancreatic adenocarcinoma is set to complete on July 10, 2025. This study, sponsored by Washington University School of Medicine, assesses safety and efficacy by comparing standard chemotherapy with the addition of the focal adhesion kinase (FAK) inhibitor defactinib. The trial aims to evaluate clinical outcomes, including progression-free survival and toxicity. Currently, the trial is active but not recruiting new participants, with a total enrollment count of 42 patients. This research could influence treatment protocols for pancreatic cancer depending on the results of the trial.
Clinical Trial CompletionWashington University School of Medicine is conducting a clinical trial for advanced pancreatic adenocarcinoma, evaluating the combination of standard chemotherapy with the FAK inhibitor defactinib versus standard chemotherapy alone. The trial, registered as NCT04331041, has an expected completion date of April 30, 2027. Currently active, the study aims to determine clinical outcomes such as progression-free survival and local control in patients randomized into two arms, with an enrollment count of 42. It is in Phase 2 of development, focusing on safety and efficacy of the novel treatment approach.
clinical trial completionVerastem, Inc. aims to have its registration statement declared effective by the SEC by July 27, 2025, as part of a plan to secure approximately $75 million in gross proceeds from a private placement. This private placement, consisting of over 3.4 million shares of common stock and pre-funded warrants, is intended to fund the potential launch of its drugs, avutometinib and defactinib, in treating low-grade serous ovarian cancer, alongside ongoing clinical research and general corporate purposes.
Registration Statement Effectiveness DeadlineAvutometinib, a focal adhesion kinase inhibitor, is being evaluated in a clinical trial for patients with advanced pancreas adenocarcinoma. The expected completion date for the clinical trial (NCT05669482) is set for December 31, 2025. The trial aims to assess the effectiveness of this drug combined with standard chemotherapy and stereotactic body radiotherapy. The strategic rationale revolves around improving patient outcomes in a challenging cancer type. The potential material financial impact remains to be determined, pending trial results.
clinical trialVerastem, Inc. is conducting a clinical trial to evaluate the safety, tolerability, and efficacy of Avutometinib (VS-6766) in combination with Adagrasib for patients with KRAS G12C mutant non-small cell lung cancer (NSCLC) who have previously been treated with a G12C inhibitor and have experienced progressive disease. The trial, which has an enrollment of 85 participants, is currently active but not recruiting and is expected to be completed by January 1, 2026. The study is registered under Clinical Trial ID: NCT05375994.
Clinical Trial CompletionThe clinical trial for Avutometinib (VS-6766) and Defactinib, targeting mesonephric gynecologic cancer, is expected to complete on March 1, 2026. The study, sponsored by Memorial Sloan Kettering Cancer Center, aims to assess the efficacy of this combination therapy in treating advanced or recurrent forms of the disease. It is currently in Phase 2, and the enrollment target is set at 40 participants. This trial reflects ongoing efforts to develop effective therapeutic options for a rare cancer type, which could have implications for future treatment protocols.
Clinical Trial CompletionThe ROCKIF trial, investigating the efficacy of VS-6063 in combination with carboplatin and paclitaxel for treating carboplatin-resistant ovarian cancer, is set for expected completion on April 1, 2026. Sponsored by Michael McHale at the University of California, San Diego, the trial is currently in the recruiting phase with an enrollment target of 90 patients. While carboplatin and paclitaxel are FDA-approved treatments, VS-6063 remains experimental. The study aims to assess both the safety of this therapeutic regimen and its potential to reduce cancerous cell levels in patients.
clinical trial completionThe clinical trial NCT05798507, sponsored by Emory University, is focused on assessing the safety and pharmacodynamics of defactinib and VS-6766 in glioblastoma patients. The trial is structured into two arms, where patients will receive a single oral dose of either drug prior to tumor resection. Currently in the recruitment phase, the trial aims to estimate optimal treatment concentrations within tumor and adjacent brain tissue. Expected completion is set for October 31, 2026. This research could provide insights into potential therapies for glioblastoma, a highly aggressive brain tumor, impacting VSTM's pipeline.
Clinical Trial Completion