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PMV Pharma Sees 46% ORR, Seeks Accelerated NDA for Rezatapopt

Aug 31, 2026, 4:04 PM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Substantial ORR and durable responses in a registrational-like Phase 2, coupled with FDA support for an accelerated NDA, create a clear near-term upside risk-reward. Historical parallels: strong phase-2-to-NDA progress often yields outsized moves, though risks include trial design limits and potential regulatory delays.

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What happened, with direct paths to the underlying reporting

PMV Pharma reported interim PYNNACLE Phase 2 ovarian cancer data for rezatapopt in TP53 Y220C tumors, showing a 46% ORR and a median DOR of 10 months. FDA feedback supports an accelerated NDA pathway with a planned Q1 2027 submission. An update on all PYNNACLE cohorts is due at a late-2026 medical conference, potentially fueling sentiment ahead of the NDA decision.

Ovarian cancer PYNNACLE interim: ORR 46% in 76 evaluable patients.
Median time to response 1.3 months; DOR 10.0 months.
FDA feedback supports NDA for accelerated approval in TP53 Y220C ovarian cancer.
NDA submission planned for Q1 2027; Q4 2026 data conference update.

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