PMV Pharma plans Q1 2027 NDA for rezatapopt; Q1 net loss $18M
PMV Pharmaceuticals reported a net loss of $18 million for the first quarter ended March 31, 2026, compared to $17.4 million in the prior year. The company ended the quarter with $93.5 million in cash, cash equivalents, and marketable securities, providing an expected cash runway to the end of Q2 2027. Key corporate highlights include the FDA granting Orphan Drug Designation to rezatapopt for TP53 Y220C positive ovarian cancer and the publication of first-in-human rezatapopt data in the New England Journal of Medicine. PMV Pharma remains on track to submit a New Drug Application (NDA) for rezatapopt in platinum-resistant/refractory ovarian cancer in Q1 2027, supported by an observed overall response rate of 44% in the PYNNACLE Phase 2 study.
Key Highlights
- Rezatapopt granted Orphan Drug Designation by FDA for TP53 Y220C positive ovarian cancer.
- New Drug Application (NDA) submission for rezatapopt planned for Q1 2027.
- Cash, cash equivalents, and marketable securities totaled $93.5 million as of March 31, 2026.
- Expected cash runway to the end of Q2 2027.
- Net loss for Q1 2026 was $18 million, compared to $17.4 million in Q1 2025.
- R&D expenses decreased to $15.3 million in Q1 2026 from $17.4 million in Q1 2025.
- Overall response rate (ORR) of 44% (32/72 patients) in Phase 2 PYNNACLE study.