PMV Pharma reports 33% response rate in TP53 Y220C mutation trial

Published 10/09/2025, 12:06
PMV Pharma reports 33% response rate in TP53 Y220C mutation trial

PRINCETON, N.J. - PMV Pharmaceuticals, Inc. (NASDAQ:PMVP), a clinical-stage biotech company with a market capitalization of approximately $85 million, reported interim data from its Phase 2 PYNNACLE clinical trial showing a 33% overall response rate among 97 evaluable patients treated with rezatapopt, its experimental therapy targeting p53 mutations. The company’s stock has shown strong momentum, gaining over 31% in the past six months, according to InvestingPro data.

The trial evaluated patients with advanced solid tumors harboring a TP53 Y220C mutation across multiple cancer types. According to the company’s press release statement, confirmed responses were observed in eight tumor types, with the highest response rate of 43% in ovarian cancer patients, where the median duration of response reached 7.6 months. While the clinical results appear promising, InvestingPro analysis indicates the company is rapidly burning through cash, with a negative free cash flow of $70 million in the last twelve months, though it maintains a healthy current ratio of 12.5.

The data showed varying response rates across cancer types, including 60% in endometrial cancer (5 patients), 22% in lung cancer (18 patients), 18% in breast cancer (11 patients), and 21% in other solid tumors (19 patients).

Treatment-related adverse events were primarily Grade 1-2, with the most common being nausea, fatigue, and elevated blood creatinine and alanine aminotransferase levels. The rate of treatment discontinuation due to adverse events was 3.7%.

Following discussions with the FDA, PMV Pharma plans to enroll an additional 20-25 platinum resistant/refractory ovarian cancer patients by the end of the first quarter of 2026. The company aims to submit a New Drug Application for this indication by the end of the first quarter of 2027.

Rezatapopt is described as a first-in-class small molecule designed to restore wild-type function to the p53 Y220C mutant protein. The FDA previously granted Fast Track designation to the therapy for treating patients with locally advanced or metastatic solid tumors with this specific mutation.

The PYNNACLE trial is ongoing, with the company expecting to complete enrollment in the Phase 2 portion by the first quarter of 2026. Analysts maintain a bullish outlook on PMVP, with price targets ranging from $5 to $18 per share. For deeper insights into biotech investment opportunities and access to over 10 additional exclusive ProTips for PMVP, consider subscribing to InvestingPro.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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