PMV Pharma completes PYNNACLE enrollment, targets Q1 2027 NDA for rezatapopt

PMV Pharmaceuticals said on August 14, 2026 that it had finished enrolling platinum-resistant/refractory ovarian cancer patients needed for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE clinical trial.¹ The study is a multicenter, single arm, registrational Phase 2 trial testing rezatapopt as monotherapy at a 2000 mg once-daily dose in patients with TP53 Y220C advanced solid tumors.¹

Based on this progress, PMV Pharma said it expects to file a New Drug Application seeking accelerated approval for rezatapopt in platinum-resistant/refractory ovarian cancer with the TP53 Y220C mutation in the first quarter of 2027.¹ CEO David Mack said the trial "continues to progress remarkably well" and reiterated the planned first-quarter 2027 NDA submission.

The broader PYNNACLE study is a Phase 1/2 trial. Its Phase 2 portion is a registrational, single arm, expansion basket design comprising five cohorts covering ovarian, lung, breast, and endometrial cancers, plus other solid tumors, run across roughly 70 sites, with the goal of measuring rezatapopt's efficacy at the recommended Phase 2 dose in patients with TP53 Y220C tumors.¹

On financials, PMV Pharma reported $79.4 million in cash, cash equivalents, and marketable securities at the end of the second quarter, down from $112.9 million at the end of 2025.¹ The company said this level of cash is expected to fund operations into the second quarter of 2027, per the release's headline summary. Net loss for the quarter was $18.1 million, versus $21.2 million in the same quarter of 2025.¹

Rezatapopt has already received Fast Track designation from the FDA for p53 Y220C-mutant solid tumors and Orphan Drug Designation for TP53 Y220C-positive ovarian, fallopian tube, and primary peritoneal cancers.¹