Rezatapopt

Princeton, New Jersey-based PMV Pharmaceuticals (Nasdaq: PMVP) announced an oversubscribed public offering expected to raise approximately USD 50.8 million in gross proceeds as it advances rezatapopt (PC14586), its lead mutant p53 reactivator, toward a planned New Drug Application (NDA) submission in Q1 2027 for platinum-resistant or refractory ovarian cancer harboring a TP53 Y220C mutation. The financing includes common stock, pre-funded warrants, and accompanying warrants that could result in substantial additional dilution if exercised. PMV held USD 79.4 million in cash, cash equivalents, and marketable securities as of June 30, 2026, with existing resources expected to fund operations through Q2 2027. The new capital provides an additional buffer around the planned NDA filing, although the company has not yet updated its formal runway guidance. Rezatapopt is a first-in-class small molecule designed to selectively bind and stabilize the thermally destabilized p53 Y220C mutant protein, restoring wild-type-like tumor suppressor activity. The compound is being evaluated in the Phase II pivotal PYNNACLE trial, a registrational basket study in advanced solid tumors harboring TP53 Y220C mutations. Updated interim data disclosed ahead of the financing showed a 46% overall response rate among 76 evaluable patients with platinum-resistant or refractory ovarian cancer, including four confirmed complete responses and 29 confirmed partial responses. Median duration of response was 10.0 months, extending the earlier dataset based on 48 evaluable patients. PMV said a recent interaction with the US FDA supports its strategy to seek accelerated approval, with an NDA submission planned in Q1 2027. The FDA has granted rezatapopt Fast Track designation for locally advanced or metastatic solid tumors with a p53 Y220C mutation and Orphan Drug Designation for TP53 Y220C-positive ovarian, fallopian tube, and primary peritoneal cancers. PMV is also working with Foundation Medicine, a Roche subsidiary, to develop FoundationOne CDx as a companion diagnostic to identify patients with TP53 Y220C-positive tumors. TP53 mutations occur in approximately half of human cancers, although the Y220C variant represents a much smaller genetically defined subset. No approved therapy currently directly targets mutant p53, leaving rezatapopt without a direct marketed comparator. Spot something wrong? Report an issue with this article

46% ORR observed among 76 evaluable patients in the ovarian cancer cohort with a median duration of response of 10.0 months Recent FDA interaction supports NDA submission strategy for accelerated approval of rezatapopt for platinum-resistant/refractory ovarian cancer, with submission planned in first quarter of 2027 PMV plans to provide an update on all PYNNACLE Phase 2 pivotal trial cohorts at a medical conference in fourth quarter of 2026 PRINCETON, N.J., Aug. 31, 2026 (GLOBE NEWSWIRE) -- 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, today announced updated interim ovarian cancer data from the Phase 2 pivotal portion of the PYNNACLE clinical trial. The multicenter, single-arm, registrational Phase 2 trial is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors. Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE Phase 2 pivotal trial has been completed. The Company plans to provide an update on all PYNNACLE Phase 2 pivotal trial cohorts at a medical conference in the fourth quarter of 2026, including the primary analysis data from the ovarian cancer cohort. PYNNACLE Phase 2 Ovarian Cancer Interim Data Update The updated interim ovarian cancer data below are summarized as of a May 14, 2026 data cutoff date. Efficacy The efficacy population consisted of 76 patients enrolled as of the data cutoff date who either had ≥1 post-baseline tumor assessment or discontinued early. Overall response rate (ORR) of 46% (35/76 patients, including four confirmed complete responses, 29 confirmed partial responses, and two unconfirmed partial responses) per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The median time to response was 1.3 months and median duration of response was 10.0 months, based on confirmed responses only. Safety Rezatapopt continues to show a favorable and consistent safety and tolerability pro all cohorts, with mostly Grade 1 and 2 treatment-related adverse events (AEs) observed as well as a low rate (5%) of discontinuation due to treatment-related AEs. The safety and tolerability pro rezatapopt in the ovarian cancer cohort was similar to the overall population. Regulatory Update In a recent meeting with the U.S. Food and Drug Administration (FDA), the Company obtained feedback that continues to support its strategy for submitting a New Drug Application (NDA) for accelerated approval of rezatapopt in patients with platinum-resistant/refractory ovarian cancer with a TP53 Y220C mutation based on the Phase 2 portion of the PYNNACLE clinical trial. The Company anticipates submitting an NDA in the first quarter of 2027. 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, conducted across approximately 70 sites. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to (NCT trial identifier NCT04585750). About PMV Pharma PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53. TP53 mutations are found in approximately half of all cancers. Our co-founder, Dr. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize more than four decades of p53 biology, PMV Pharma combines unique biological understanding with a pharmaceutical development focus. PMV Pharma is headquartered in Princeton, New Jersey. For more information, please visit . Forward-Looking Statements Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s future plans or expectations for rezatapopt, including the Company’s ability to obtain approval as a treatment option as a monotherapy, expectations regarding timing, enrollment status and success of the Phase 2 portion of the current clinical trial for rezatapopt and the timing of a filing of a New Drug Application (NDA) for platinum-resistant/refractory ovarian cancer, the expectations and timing regarding receipt and disclosures of data results from clinical trials, the adequacy of the data from clinical trials to support proof-of-concept and/or the Company’s pursuit of regulatory approval of a NDA, the benefits of FDA’s grant of Orphan Drug Designation (ODD) for rezatapopt, and the timing and expectations with respect to the Company’s projected cash runway. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company’s product candidate development activities, including the successful filing of NDAs, and planned clinical trials, the Company’s ability to execute on its strategy and operate as a clinical stage company, the potential for clinical trials of rezatapopt or any future clinical trials of other product candidates to differ from preclinical, preliminary or expected results, maintenance by the Company of ODD status and related benefits for rezatapopt, the Company’s ability to fund operations, and the impact that a global pandemic, other public health emergencies or geopolitical tensions or conflicts may have on the Company’s clinical trials, supply chain, and operations, as well as those risks and uncertainties set forth in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 6, 2026, most recent Quarterly Report on Form 10-Q, filed with the SEC on August 14, 2026, and its other filings filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Contacts Investors Contact: Tim Smith Senior Vice President, Head of Corporate Development and Investor Relations investors@pmvpharma.com Media Contact: Kathy Vincent Greig Communications kathy@greigcommunications.com