On March 6, 2026 PMV Pharmaceuticals, Inc. ("PMV Pharma" or the "Company"; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, reported financial results for the full year ended December 31, 2025, and provided a corporate update.
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"2025 was an important and productive year for PMV Pharma as we reported positive Phase 2 interim data from the registrational PYNNACLE clinical trial and made significant progress in enrolling the study," said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. "We look forward to submitting an NDA in the first quarter of 2027 for rezatapopt in platinum-resistant/refractory ovarian cancer."
PYNNACLE Phase 2 Monotherapy Update:
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Enrollment is on track in the Phase 2 monotherapy portion of the PYNNACLE clinical trial. The multicenter, single-arm, registrational, Phase 2 study is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors.
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PMV Pharma anticipates submitting a New Drug Application (NDA) for rezatapopt in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation in the first quarter of 2027.
Full Year 2025 and Recent Corporate Highlights:
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On March 2, 2026, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to rezatapopt for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The FDA provides ODD status to drugs intended for the safe and effective treatment, diagnosis, or prevention of rare diseases that affect fewer than 200,000 people in the U.S. Benefits of the designation may include exemption from certain FDA fees, financial incentives for qualified clinical development, and seven years of market exclusivity in the U.S. if the treatment is approved.
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Phase 1 results from the ongoing Phase 1/2 PYNNACLE study were published in the New England Journal of Medicine, "Phase 1 Study of Rezatapopt, a p53 Reactivator, in TP53 Y220C-Mutated Tumors." The manuscript highlighted that rezatapopt demonstrated antitumor activity in heavily pretreated patients across multiple solid tumor types which provided proof-of-concept for p53 reactivation. Clinical activity and biomarker data were consistent with selective binding to the Y220C pocket and restoration of wild-type p53 tumor suppressor function.
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Updated data from the ongoing PYNNACLE Phase 2 trial were presented as an oral presentation at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) based on a September 4, 2025 data cut-off.
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34% overall response rate (ORR) observed among 103 evaluable patients across all cohorts with a median duration of response of 7.6 months.
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46% ORR observed among 48 evaluable patients in ovarian cancer cohort with a median duration of response of 8.0 months.
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Treatment-related adverse events (TRAEs) were mostly Grade 1-2 with the most frequent TRAEs observed (>15%) being nausea, fatigue, blood creatinine increased, and alanine aminotransferase (ALT) increased.
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Natural history study results were also presented at the 2025 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) where TP53 Y220C–mutant advanced solid tumors were associated with poor outcomes reinforcing the significant unmet medical need addressed by rezatapopt.
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New findings from the rezatapopt PYNNACLE Phase 2 trial in ovarian cancer were presented at the 2026 European Society of Gynecologic Oncology Congress, demonstrating robust and consistent ORRs across key ovarian cancer subgroups.
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The ORR subgroup data included those with platinum-resistant, platinum-refractory disease, prior systemic therapies and folate receptor alpha status, that provide further evidence of the broad efficacy of rezatapopt within ovarian cancer patients.
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After the September 4, 2025 data cut-off, among the 48 evaluable patients in the ovarian cancer cohort, a 50% ORR was observed with 23 confirmed responses and one unconfirmed partial response.
Fiscal Year 2025 Financial Results
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As of December 31, 2025, PMV Pharma had $112.9 million in cash, cash equivalents, and marketable securities, compared to $183.3 million at December 31, 2024. Net cash used in operations was $73.6 million for the year ended December 31, 2025, compared to $51.3 million for the year ended December 31, 2024.
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Net loss for the year ended December 31, 2025, was $77.7 million compared to $58.7 million for the year ended December 31, 2024.
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Research and development (R&D) expenses were $69.9 million for the year ended December 31, 2025, compared to $58.5 million for the year ended December 31, 2024. The increase in R&D expenses was primarily related to clinical expenses for advancing rezatapopt, the Company’s lead product candidate.
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General and administrative (G&A) expenses were $16.3 million for the year ended December 31, 2025, compared to $26.9 million for the year ended December 31, 2024. The decrease in G&A expenses was primarily due to lower facility-related and personnel costs following the relocation of the Company’s lab and office space and staff reductions in the prior year.
About Rezatapopt
Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation and Orphan Drug Designation for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.
About the PYNNACLE Clinical Trial
The ongoing Phase 1/2 PYNNACLE clinical trial is evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The primary objective of the Phase 1 portion of the clinical trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with TP53 Y220C and KRAS wild-type advanced solid tumors, conducted across approximately 70 sites.
For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).
(Press release, PMV Pharma, MAR 6, 2026, View Source [SID1234663334])