PRINCETON, N.J., Aug. 14, 2026
PMV Pharmaceuticals, Inc. reported continued progress in its Phase 2 PYNNACLE clinical trial evaluating rezatapopt in patients with TP53 Y220C-mutated advanced solid tumors, with enrollment now completed for platinum-resistant/refractory ovarian cancer patients included in the primary analysis. The company said the completion of enrollment represents an important development for the registrational program and supports its plan to pursue an NDA submission for accelerated approval in the first quarter of 2027 for rezatapopt in patients with platinum-resistant/refractory ovarian cancer carrying the TP53 Y220C mutation. PMV Pharmaceuticals is developing rezatapopt as a precision oncology therapy targeting the p53 Y220C mutation, a molecular alteration associated with multiple cancers.
PYNNACLE Trial Reaches Key Ovarian Cancer Enrollment Milestone
The PYNNACLE Phase 2 monotherapy study is a multicenter, single-arm, registrational clinical trial evaluating rezatapopt at 2,000 mg once daily in patients with advanced solid tumors harboring a TP53 Y220C mutation. PMV Pharmaceuticals has completed enrollment of patients with platinum-resistant/refractory ovarian cancer for the primary analysis of this portion of the study. The company expects the clinical development program to provide the data needed to support its planned regulatory strategy for this difficult-to-treat patient population. The anticipated first-quarter 2027 NDA submission is intended to seek accelerated approval for rezatapopt in platinum-resistant/refractory ovarian cancer patients whose tumors carry the TP53 Y220C mutation. The development milestone places the program closer to a potential regulatory review while the company continues to advance the broader PYNNACLE program
Rezatapopt Targets TP53 Y220C in Precision Oncology
Rezatapopt (PC14586) is being developed as a first-in-class small-molecule p53 reactivator designed to selectively bind the p53 Y220C mutant protein and restore its tumor-suppressor function. The approach is intended to address cancers driven by a specific TP53 mutation, allowing PMV Pharmaceuticals to pursue a genetically defined patient population rather than treating tumors solely according to their tissue of origin. The ongoing Phase 1/2 PYNNACLE trial is evaluating rezatapopt across advanced solid tumors carrying TP53 Y220C mutations. Its Phase 2 portion includes expansion cohorts covering ovarian, lung, breast, endometrial and other solid tumors, with the study being conducted across approximately 70 sites. The U.S. FDA has previously granted Fast Track designation to rezatapopt for locally advanced or metastatic solid tumors with a p53 Y220C mutation, while Orphan Drug Designation has been granted for TP53 Y220C-positive ovarian, fallopian tube and primary peritoneal cancers.
PMV Pharmaceuticals Reports Q2 Financial Position
PMV Pharmaceuticals ended the second quarter of 2026 with $79.4 million in cash, cash equivalents and marketable securities, compared with $112.9 million at the end of 2025, which the company expects to provide a cash runway through the second quarter of 2027. Net cash used in operations during the first six months of 2026 was $34.3 million, compared with $36.6 million during the same period in 2025. The company reported a second-quarter net loss of $18.1 million, compared with $21.2 million in the prior-year quarter. Research and development expenses declined to $14.7 million from $18.4 million, primarily reflecting lower contract research organization costs associated with advancement of the rezatapopt program. General and administrative expenses were $4.2 million, compared with $4.5 million in the second quarter of 2025. With ovarian cancer enrollment completed and the 2027 NDA submission planned, PMV Pharmaceuticals is entering a significant regulatory and clinical development phase for rezatapopt.
Source:PMV Pharmaceuticals,, press relese



