PMV Pharmaceuticals Inc. (NASDAQ: PMVP ) on Monday shared interim data from its Phase 2 PYNNACLE trial for rezatapopt, an investigational treatment for ovarian cancer .
Based on this data, the company announced its plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of the drug.
Efficacy Highlights
The interim data, gathered up to May 14, 2026, focus on patients with platinum-resistant or refractory ovarian cancer bearing the TP53 Y220C mutation.
The trial results demonstrated a 46% overall response rate (ORR) among the 76 patients evaluated. This included four confirmed complete responses and 29 confirmed partial responses .
Rezatapopt also showed a median duration of response of 10.0 months, indicating sustained effectiveness.
The drug’s safety profile remained favorable, primarily presenting Grade 1 and 2 treatment-related adverse events, with a low 5% discontinuation rate linked to these events .
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The company plans to present a comprehensive update on all PYNNACLE Phase 2 cohorts at an upcoming medical conference in the fourth quarter of 2026.
TrendingFollowing a recent FDA meeting, PMV Pharmaceuticals received feedback supporting its strategy to seek accelerated approval for rezatapopt. The company intends to submit the NDA in the first quarter of 2027 .
Funding The Future
In related news, PMV Pharmaceuticals priced a public offering expected to generate approximately $50.8 million in gross proceeds .
The offering includes shares of common stock, pre-funded warrants, and accompanying warrants, with a combined public offering price of $1.21 per share and warrant combination.
The financial move supports the company’s ongoing research and anticipated regulatory submissions.
PMVP Price Action: PMV Pharmaceuticals shares were down 10.74% at $1.08 during premarket trading on Tuesday, according to Benzinga Pro data .
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