PMV Pharmaceuticals, Inc. (PMVP), a clinical-stage oncology company, reported financial results for the full year 2025 and provided details of the milestones ahead for its lead drug candidate, Rezatapopt.
Net loss for the year widened to $77.7 million or $1.48 per share from $58.7 million or $1.14 per share in the prior year.
As of December 31, 2025, PMV Pharma had $112.9 million in cash, cash equivalents, and marketable securities, compared to $183.3 million in the prior year. The firm noted that this provides expected cash runway to end of second quarter of 2027
The company's lead investigational candidate Rezatapopt (PC14586) is a small molecule p53 reactivator to restore the wild-type tumor-suppressor function.
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 along with safety, tolerability, pharmacokinetics and effects on biomarkers.
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.
New findings from the rezatapopt PYNNACLE Phase 2 trial in ovarian cancer presented at the 2026 European Society of Gynecologic Oncology Congress, demonstrated consistent Overall Response Rates (ORR) across key ovarian cancer subgroups.
The ORR subgroup data included those with platinum-resistant, platinum-refractory disease, prior systemic therapies and folate receptor alpha status. After data cut-off on September 4, 2025, among the 48 evaluable patients in the ovarian cancer cohort, a 50% ORR was observed with 23 confirmed responses and one unconfirmed partial response.
Following that on March 2,2026, the FDA 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.
Enrollment is on track in the Phase 2 monotherapy portion of the PYNNACLE clinical trial is in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation.
If everything goes well, 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.
PMVP has traded between $0.8100 and $1.88 in the last 1 year. The stock closed Friday's trade at $1.64, up 7.19%.
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