PMV Pharmaceuticals Gains FDA ODD, Reports 44% ORR and $93.5M Cash
PMV Pharma reported $93.5 million in cash providing runway into Q2 2027, and net cash used was $19.7 million in Q1 2026 with an $18 million net loss. Rezatapopt received FDA Orphan Drug Designation for TP53 Y220C ovarian cancer and achieved a 44% overall response rate in Phase 2 PYNNACLE.
1. Financial Performance
PMV Pharma ended Q1 2026 with $93.5 million in cash, cash equivalents and marketable securities, compared with $112.9 million at year-end 2025, providing runway into Q2 2027. Net cash used in operations was $19.7 million and net loss was $18.0 million for the quarter, driven by research and development and general and administrative expenses.
2. Phase 2 PYNNACLE Update
Enrollment in the registrational Phase 2 monotherapy PYNNACLE trial is on track, with an investigator-assessed overall response rate of 44% (32 of 72 patients) in TP53 Y220C advanced solid tumors, including platinum-resistant ovarian cancer. The median time to response was 1.3 months and duration of response was 8.2 months, with ORR rising to 46% (34 of 74) including unconfirmed responses post-data cutoff.
3. Regulatory Milestones
Rezatapopt secured FDA Orphan Drug Designation for TP53 Y220C positive ovarian, fallopian tube and primary peritoneal cancers, and received Fast Track status for advanced solid tumors with p53 Y220C mutations, which may expedite development, reduce fees and grant seven years of market exclusivity upon approval.
4. Planned NDA Submission
PMV Pharma plans to submit a New Drug Application for rezatapopt in platinum-resistant/refractory ovarian cancer patients with TP53 Y220C mutations in the first quarter of 2027, advancing its precision oncology pipeline toward potential commercialization.