PMV Pharma Reports $112.9M Cash Runway, FDA Orphan-Drug Status and Rezatapopt NDA in Q1 2027
PMV Pharma ended 2025 with $112.9 million in cash, funding operations into Q2 2027 despite a $77.7 million net loss. Phase 2 PYNNACLE enrollment for rezatapopt monotherapy in TP53 Y220C platinum-resistant or refractory ovarian cancer remains on track, with FDA orphan-drug status and NDA planned for Q1 2027.
1. 2025 Financial Results
PMV Pharma closed the year with $112.9 million in cash, cash equivalents and marketable securities, a net loss of $77.7 million and net cash used in operations of $73.6 million. Research and development expenses rose to $69.9 million while general and administrative costs fell to $16.3 million, securing funding into the second quarter of 2027.
2. Phase 2 PYNNACLE Clinical Progress
Enrollment in the registrational Phase 2 PYNNACLE trial of rezatapopt monotherapy at 2000 mg once daily remains on track for platinum-resistant/refractory TP53 Y220C mutant ovarian cancer. As of the September 4, 2025 data cut-off, the trial showed a 34% overall response rate among 103 evaluable patients, a 46% ORR in the ovarian cohort (median duration 8.0 months) and a post–cut-off 50% ORR in 48 ovarian patients.
3. Regulatory and Publication Highlights
The FDA granted Orphan Drug Designation for rezatapopt in TP53 Y220C positive ovarian, fallopian tube and primary peritoneal cancers, qualifying for potential fee exemptions and seven years of market exclusivity upon approval. First-in-human rezatapopt data published in the New England Journal of Medicine demonstrated selective mutant p53 reactivation and antitumor activity across advanced solid tumors.
4. NDA Submission Plans
PMV Pharma anticipates submitting a New Drug Application for rezatapopt in platinum-resistant/refractory ovarian cancer with TP53 Y220C mutation in the first quarter of 2027, marking a key regulatory milestone toward potential commercialization.