PMV Pharmaceuticals, Inc. is a precision oncology company, which engages in the discovery and development of small molecule, tumor-agnostic therapies targeting p53. The company was founded by Arnold J. Levine, David Henry Mac, and Thomas E. Shenk in March 2013 and is headquartered in Princeton, NJ.
Clinical Trials
7
0 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2013
Completed
4
57.1%
Recruiting
3
42.9%
No approval data available
- PMV Pharma completed enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE trial. - The company plans to submit a New Drug Application for accelerated approval of rezatapopt in the first quarter of 2027. - Rezatapopt is a first-in-class p53 reactivator targeting the TP53 Y220C mutation, with Fast Track and Orphan Drug Designations from the FDA. - PMV Pharma reported $79.4 million in cash and marketable securities as of June 30, 2026, providing runway through the second quarter of 2027.
- PMV Pharmaceuticals is a clinical-stage biotech focused on precision oncology therapies that modulate the p53 tumor suppressor pathway, frequently altered in solid tumors. - The company's pipeline centers on identifying specific mutations and molecular profiles where p53-targeted drugs could deliver clinical benefit, with early trials focused on safety, dosage, and efficacy signals. - As a small-cap Nasdaq listing with a market capitalization of 68.961 million USD, PMV Pharmaceuticals relies on cash reserves, equity issuance, and partnerships to fund its R&D. - Regulatory interactions with agencies such as the FDA are central to the company's trajectory, with positive feedback potentially enabling accelerated pathways for serious or rare cancers.
- PMV Pharmaceuticals published first-in-human Phase 1 results for rezatapopt in the New England Journal of Medicine, demonstrating selective p53 reactivation in 77 heavily pretreated patients with TP53 Y220C-mutated solid tumors. - The study established proof-of-concept for p53 reactivation therapy, with objective responses observed across multiple tumor types and all responding patients having TP53 Y220C mutations and KRAS wild-type status. - Updated Phase 2 data showed an overall response rate of 34% across all cohorts and 46% in ovarian cancer patients, with median duration of response reaching 8.0 months in the ovarian cancer cohort. - The company plans to submit a New Drug Application for platinum-resistant/refractory ovarian cancer in Q1 2027, with rezatapopt receiving FDA Fast Track designation for advanced solid tumors with p53 Y220C mutations.
- PMV Pharma reported interim Phase 2 PYNNACLE trial results showing rezatapopt achieved a 33% overall response rate across eight tumor types in patients with TP53 Y220C mutations. - The ovarian cancer cohort demonstrated the strongest efficacy with a 43% response rate and 7.6-month median duration of response among 44 evaluable patients. - Safety data from 109 patients showed mostly Grade 1-2 treatment-related adverse events with only 3.7% discontinuation rate due to adverse events. - Following FDA feedback, PMV Pharma plans to enroll additional platinum-resistant ovarian cancer patients by Q1 2026 and submit a New Drug Application by Q1 2027.
- PMV Pharmaceuticals' PYNNACLE trial advances with Rezatapopt monotherapy for TP53 Y220C mutated solid tumors, showing over 75% site activation across multiple regions. - A Phase 1b study will assess Rezatapopt with azacitidine for relapsed/refractory AML/MDS with TP53 Y220C mutation, beginning enrollment in early 2025. - Rezatapopt's exposure levels improved when taken with food, reducing gastrointestinal adverse events, supporting the 2000 mg QD dose in the PYNNACLE Phase 2 study.
- PMV Pharmaceuticals is advancing PC14586 (rezatapopt) in a Phase 2 monotherapy trial (PYNNACLE) for solid tumors with p53 Y220C mutations, with interim data expected by mid-2025. - The company discontinued the Phase 1b combination arm of the PYNNACLE trial, which evaluated rezatapopt with pembrolizumab (KEYTRUDA®). - Collaborations with MD Anderson and Memorial Sloan Kettering will support a Phase 1b study combining rezatapopt with azacytidine, starting in Q1 2025. - PMV's current funds should support operations through 2026, focusing on PC14586's clinical development and regulatory milestones.
- Rezatapopt monotherapy continues in a phase 2 trial for TP53 Y220C-mutated, KRAS wild-type advanced solid tumors, showing promising early response rates. - A phase 1b trial of rezatapopt combined with azacitidine is planned for recurrent or refractory AML/MDS with TP53 Y220C mutation, starting in early 2025. - The combination arm of rezatapopt plus pembrolizumab was discontinued due to dose-limiting toxicities and lack of clinical benefit in solid tumors. - Interim data from the rezatapopt monotherapy trial is expected by mid-2025, with a potential NDA submission by the end of 2026.
- Rezatapopt, a first-in-class p53 Y220C reactivator, targets the once 'undruggable' p53 Y220C mutation, prevalent in about 1% of all cancers, offering a tumor-agnostic approach. - Phase 1 data from the PYNNACLE study demonstrated an overall response rate of 34% in efficacy-evaluable patients treated with rezatapopt monotherapy across various advanced solid tumors. - The agent exhibited a favorable safety profile, with mostly grade 1 or 2 treatment-related adverse events, and manageable gastrointestinal toxicities when administered with food. - Phase 2 of the PYNNACLE study is underway, evaluating rezatapopt in specific cancer cohorts, with potential for accelerated approval based on promising initial results.
- PMV Pharmaceuticals reported a net loss of $69.0 million for 2023, an improvement from the previous year, with increased R&D investments focused on advancing rezatapopt. - The company's strong financial position, with $228.6 million in cash reserves, extends its operational runway to the end of 2026, prioritizing rezatapopt development. - Clinical trials for rezatapopt are progressing, including the initiation of a Phase 2 trial in Q1 2024 and enrollment in the PYNNACLE study combination arm with KEYTRUDA. - Strategic leadership appointments, including a new clinical advisor and CFO, support PMV Pharmaceuticals' commitment to precision oncology and innovative cancer therapies.
- PMV Pharma's rezatapopt is the first p53(Y220C) mutant stabilizer to enter clinical trials, targeting a common cancer mutation. - The drug is designed to bind to and stabilize the p53(Y220C) mutant, restoring its tumor-suppressing function in various solid tumors. - Early clinical results indicate potential efficacy across a range of solid tumors, marking a significant advancement in oncology. - Rezatapopt represents a novel approach to cancer therapy by directly addressing p53 mutations, present in over 50% of malignancies.
