News & Events zu PMV Pharmaceuticals Inc (PMVP)PMVPPMV Pharmaceuticals Inc

PMV Pharmaceuticals Updates Ovarian Cancer Clinical Trial Data

PMV Pharmaceuticals announced updated interim ovarian cancer data from the Phase 2 pivotal portion of the PYNNACLE clinical trial. The multicenter, single-arm, registrational Phase 2 trial is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors. Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE Phase 2 pivotal trial has been completed. The company plans to provide an update on all PYNNACLE Phase 2 pivotal trial cohorts at a medical conference in the fourth quarter of 2026, including the primary analysis data from the ovarian cancer cohort. The updated interim ovarian cancer data below are summarized as of a May 14 data cutoff date. The efficacy population consisted of 76 patients enrolled as of the data cutoff date who either had greater than or equal to1 post-baseline tumor assessment or discontinued early. Overall response rate of 46% per investigator assessment according to Response Evaluation Criteria in Solid Tumors version 1.1. The median time to response was 1.3 months and median duration of response was 10 months, based on confirmed responses only. Rezatapopt continues to show a favorable and consistent safety and tolerability profile across all cohorts, with mostly Grade 1 and 2 treatment-related adverse events observed as well as a low rate of discontinuation due to treatment-related AEs. The safety and tolerability profile of rezatapopt in the ovarian cancer cohort was similar to the overall population. In a recent meeting with the FDA, the company obtained feedback that continues to support its strategy for submitting a new drug application, or NDA, for accelerated approval of rezatapopt in patients with platinum-resistant/refractory ovarian cancer with a TP53 Y220C mutation based on the Phase 2 portion of the PYNNACLE clinical trial. The company anticipates submitting an NDA in the first quarter of 2027.

PMV Pharmaceuticals Commences Underwritten Public Offering of Stock and Warrants

PMV Pharmaceuticals announced that it has commenced an underwritten public offering of shares of its common stock and accompanying warrants to purchase shares of its common stock and, in lieu of common stock, to certain investors, pre-funded warrants to purchase shares of its common stock and accompanying warrants to purchase shares of its common stock. All of the shares, pre-funded warrants and accompanying common stock warrants to be sold in the proposed offering are to be sold by PMV Pharma. TD Cowen is acting as the sole book-running manager for the proposed offering.

PMV Pharma Targets NDA Submission for rezatapopt in 2027

"The first quarter was one of continued execution as we advance the PYNNACLE study and remain on track to target an NDA submission for rezatapopt for platinum-resistant/refractory ovarian cancer in the first quarter of 2027," said David Mack, President and Chief Executive Officer of PMV Pharma. "We are also encouraged by the publication of the PYNNACLE Phase 1 results in the New England Journal of Medicine, which underscores the scientific innovation behind rezatapopt and highlights its potential to address a significant unmet medical need. Patients with TP53 Y220C advanced solid tumors, including platinum resistant ovarian cancer, experience poor outcomes despite available therapies."