Clinical trialsCompany release

PMV Pharma plans Q1 2027 NDA for rezatapopt in TP53 Y220C ovarian cancer

🇺🇸 PMV Pharmaceuticals, Inc. (PMVP) · Tue 10 Nov 2026

The US biotech reported a 46% overall response rate in 76 patients with platinum-resistant or refractory ovarian cancer and said a $50 million offering extends its cash runway into Q1 2028.

PMV Pharmaceuticals said on 10 November 2026 that it intends to submit a new drug application to the US Food and Drug Administration in the first quarter of 2027 for rezatapopt. The company will seek accelerated approval in platinum-resistant or refractory ovarian cancer with a TP53 Y220C mutation.

The plan rests on interim data from the Phase 2 PYNNACLE trial. In 76 patients, the overall response rate was 46%. The company also reported a low treatment-related discontinuation rate of 5%.

PMV will present full data from the pivotal cohort at ENA 2026. The source material does not give further detail on the data package, so the full results will matter for assessing how robust the efficacy and safety evidence is.

In its third-quarter report, PMV said it held $108.5 million in cash. Following a $50 million public offering, it expects its cash runway to extend into the first quarter of 2028.

As general context, accelerated approval is a US pathway that allows earlier authorisation of medicines for serious conditions on the basis of surrogate or intermediate endpoints, typically with confirmatory evidence required after approval.

What it means for your team

  • Regulatory teams should watch for the NDA submission in Q1 2027 and for any FDA decision on the accelerated approval request.
  • The full pivotal cohort data at ENA 2026 will provide the first detailed view of the evidence behind the planned filing.
  • The 5% treatment-related discontinuation rate is an early tolerability signal that pharmacovigilance teams may track as more safety data emerge.
  • Market-access planners tracking TP53 Y220C-mutated ovarian cancer should note the intended indication in platinum-resistant or refractory disease.

Company's press release (SEC filing): PMV Pharmaceuticals, Inc. ↗

Article written by VigiEye from the official source (PMV Pharmaceuticals, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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