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PMV Pharmaceuticals reports news as a precision oncology company developing small molecule therapies that target p53. Its recurring updates center on rezatapopt, an oral product candidate designed to reactivate mutant p53 in tumors with the TP53 Y220C mutation, and on the PYNNACLE clinical trial in advanced solid tumors, including ovarian cancer.
Company announcements also cover clinical data presentations and publications, FDA designation activity, periodic financial results, research and development spending tied to rezatapopt, cash runway commentary, and board governance changes.
PMV Pharma (Nasdaq: PMVP) reported Q1 2026 results and rezatapopt milestones. Rezatapopt received FDA Orphan Drug Designation for TP53 Y220C positive ovarian, fallopian tube, and primary peritoneal cancers, and Phase 1 data were published in the New England Journal of Medicine.
Phase 2 PYNNACLE monotherapy showed a 44–46% ORR in platinum-resistant/refractory ovarian cancer. An NDA submission is planned for Q1 2027. Cash, cash equivalents, and marketable securities were $93.5 million, providing expected runway to end of Q2 2027; Q1 net loss was $18.0 million.
PMV Pharma (Nasdaq: PMVP) announced a Board leadership change: Laurie Stelzer will become Board Chair effective at the 2026 Annual Meeting on June 4, 2026, succeeding Rich Heyman, Ph.D., who will retire and not stand for reelection.
The Company says enrollment continues in the registrational PYNNACLE trial for rezatapopt in TP53 Y220C advanced solid tumors, with an anticipated NDA submission in Q1 2027 for platinum-resistant/refractory ovarian cancer patients with the TP53 Y220C mutation.
PMV Pharmaceuticals (Nasdaq: PMVP) reported full-year 2025 results and clinical progress for rezatapopt. Key clinical highlights include FDA Orphan Drug Designation (Mar 2, 2026), NEJM publication of Phase 1 data, Phase 2 PYNNACLE activity with ovarian cohort ORRs up to 50% post-cutoff, and an NDA planned for Q1 2027. Financials: $112.9M cash and marketable securities as of Dec 31, 2025, net loss of $77.7M, and net cash used in operations of $73.6M, providing runway to end of Q2 2027.
PMV Pharma (Nasdaq: PMVP) reported that Phase 1, first-in-human rezatapopt data were published in the New England Journal of Medicine on Feb 26, 2026. The Phase 1 portion enrolled 77 heavily pretreated TP53 Y220C-mutant patients, showed objective responses across tumor types, supported an RP2D, and demonstrated safety, pharmacokinetics, and biomarker evidence of selective Y220C p53 reactivation. The company plans a New Drug Application submission in Q1 2027 for platinum-resistant/refractory ovarian cancer and reported Phase 2 interim ORR of 34% overall and 46% in ovarian cancer (data cutoff Sep 4, 2025).
PMV Pharmaceuticals (Nasdaq: PMVP) reported third-quarter 2025 results and clinical updates on rezatapopt from the Phase 2 pivotal PYNNACLE study presented at the 2025 AACR-NCI-EORTC conference on October 24, 2025.
Key clinical data: 34% ORR (35/103) across evaluable patients, 46% ORR in the ovarian cohort (22/48) with one confirmed complete response and median duration of response of 8.0 months in ovarian patients. Median time to response across cohorts was 1.3 months. The company plans an NDA submission for platinum-resistant/refractory ovarian cancer in Q1 2027.
Financials: cash, equivalents, and marketable securities of $129.3M as of September 30, 2025, providing expected runway to end of Q1 2027. Net cash used in operations was $56.4M for the nine months ended September 30, 2025.
PMV Pharmaceuticals (Nasdaq: PMVP) reported updated Phase 2 PYNNACLE monotherapy data for rezatapopt (TP53 Y220C) with a 34% ORR across 103 evaluable patients and median duration of response of 7.6 months (data cutoff Sept 4, 2025). Confirmed responses appeared in eight tumor types including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary cancer.
The ovarian cohort showed a 46% ORR (22/48) with median duration of response 8.0 months. Safety was mostly Grade 1–2; Grade 3 TRAEs ≤6% and drug discontinuations due to TRAEs were 3.6%. An NDA for platinum-resistant/refractory ovarian cancer is planned for Q1 2027.
PMV Pharmaceuticals (NASDAQ: PMVP) will present initial clinical data for rezatapopt at the AACR-NCI-EORTC conference in Boston on October 22–26, 2025. An oral presentation will report an initial analysis of the pivotal PYNNACLE Phase 2 trial in patients with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation on Friday, October 24 at 10:00–11:40 AM ET, presented by Dr. Alison M. Schram.
Two poster presentations will follow: the PYNNACLE initial analysis on Friday, October 24 (12:30–4:00 PM ET, Poster Session B, Exhibit Hall D) and a real-world natural history and prognostic study of TP53 Y220C on Saturday, October 25 (12:30–4:00 PM ET, Poster Session C, Exhibit Hall D).
PMV Pharmaceuticals (NASDAQ:PMVP) announced promising interim data from its Phase 2 PYNNACLE trial evaluating rezatapopt in patients with TP53 Y220C-mutated advanced solid tumors. The trial demonstrated a 33% overall response rate (ORR) across 97 evaluable patients, with confirmed responses in eight different tumor types.
Key highlights include a 43% ORR in ovarian cancer patients with 7.6 months median duration of response. The safety profile showed mostly Grade 1-2 treatment-related adverse events, with a low 3.7% discontinuation rate. Following FDA feedback, PMV plans to enroll an additional 20-25 platinum resistant/refractory ovarian cancer patients and submit a New Drug Application (NDA) in Q1 2027.
PMV Pharmaceuticals (NASDAQ:PMVP), a precision oncology company, has announced its Q2 2025 financial results and will host an investor webinar on September 10, 2025 to review interim analysis data from the Phase 2 PYNNACLE clinical trial. The analysis will include data from approximately 65 patients with at least 18 weeks of follow-up, with about 45% in the ovarian cancer cohort.
The company reported $148.3 million in cash and equivalents as of June 30, 2025, providing runway through 2026. Q2 2025 net loss was $21.2 million, compared to $1.2 million in Q2 2024. R&D expenses increased to $18.4 million, while G&A expenses decreased to $4.5 million.
PMV Pharmaceuticals (PMVP), a precision oncology company focused on developing small molecule, tumor-agnostic therapies targeting p53, has announced its participation in two upcoming investor conferences. The company's management, including CEO David H. Mack and Chief Development Officer Deepika Jalota, will present at the TD Cowen 6th Annual Oncology Innovation Summit on May 27, 2025, at 11:30 AM EDT, and the Jefferies Global Healthcare Conference on June 5, 2025, at 3:45 PM EDT. Both presentations will be available via live audio webcast, with replays accessible for 90 days afterward.