PMV Pharma reports Q3 2026 results, plans rezatapopt NDA filing in Q1 2027
PMV Pharma said completed enrollment and updated Phase 2 data support an accelerated approval filing for ovarian cancer, backed by a $50 million offering.
PMV Pharmaceuticals reported third quarter 2026 results on November 10, 2026, and said it still plans to submit a New Drug Application for rezatapopt in platinum-resistant/refractory ovarian cancer in the first quarter of 2027, as CEO David Mack said the completed $50 million public offering positions the company to submit an NDA in the first quarter of 2027 seeking accelerated approval for treatment of platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation.1
The company said enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE clinical trial is finished.1 PMV said it plans to present updated data from all PYNNACLE Phase 2 pivotal trial cohorts, including the primary analysis population from the ovarian cancer cohort, in a late-breaking oral talk at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, known as ENA 2026.1
Based on a May 14, 2026 data cutoff, the efficacy population included 76 patients who had at least one post-baseline tumor assessment or discontinued early, with an overall response rate of 46 percent, made up of four confirmed complete responses, 29 confirmed partial responses, and two unconfirmed partial responses, by investigator assessment under RECIST 1.1.1 The company reported that median time to response was 1.3 months and median duration of response was 10.0 months among confirmed responders.1 On safety, PMV said adverse events were mostly Grade 1 and 2 across cohorts, with a 5 percent discontinuation rate due to treatment-related events, and the ovarian cancer cohort's safety profile was similar to the overall population.1
PMV also appointed Matt Eckler of Samsara BioCapital to its board and named Philip Herman as Chief Commercial Officer.1
On finances, the company ended the quarter with $108.5 million in cash, cash equivalents, and marketable securities, down from $112.9 million at the end of 2025,1 and said this gives it a runway into the first quarter of 2028 following the closing of an oversubscribed $50 million public offering.1
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