PMV Pharmaceuticals' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by PMV Pharmaceuticals (PMVP).
Over the past two years, PMV Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
rezatapopt. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Rezatapopt FDA Regulatory Events
Rezatapopt is a drug developed by PMV Pharmaceuticals for the following indication: in patients with advanced solid tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- rezatapopt
- Announced Date:
- September 10, 2025
- Indication:
- in patients with advanced solid tumors
Announcement
PMV Pharmaceuticals, announced interim data from the Phase 2 pivotal portion of 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.
AI Summary
PMV Pharmaceuticals announced interim data from the Phase 2 pivotal portion of its PYNNACLE trial, testing rezatapopt in patients with advanced solid tumors carrying the TP53 Y220C mutation. Among 97 evaluable patients treated with daily 2,000 mg monotherapy, the overall response rate (ORR) was 33%, with confirmed responses in eight tumor types: ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder, and ampullary cancers. The median duration of response was 6.2 months.
In the ovarian cancer cohort of 44 patients, ORR reached 43%, including one complete response and 17 confirmed partial responses. The median duration of response in this group was 7.6 months, and across all cohorts the median time to response was 1.4 months.
Rezatapopt’s safety profile showed mostly mild (Grade 1–2) side effects, like nausea and fatigue, with few treatment discontinuations. PMV Pharma plans to submit a New Drug Application for platinum-resistant/refractory ovarian cancer in the first quarter of 2027.
Read Announcement- Drug:
- rezatapopt
- Announced Date:
- May 29, 2024
- Indication:
- in patients with advanced solid tumors
Announcement
Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc. announced a partnership to develop Foundation Medicine's tissue-based comprehensive genomic profiling test, FoundationOne®CDx, as a companion diagnostic for PMV Pharma's rezatapopt, a first-in-class, investigational therapy for patients with locally advanced or metastatic solid tumors that have a TP53 Y220C mutation.
AI Summary
Foundation Medicine, Inc. and PMV Pharmaceuticals, Inc. have announced a new partnership to develop Foundation Medicine’s tissue-based genomic profiling test, FoundationOne®CDx, as a companion diagnostic for PMV Pharma’s investigational drug, rezatapopt. This therapy is being studied for patients with locally advanced or metastatic solid tumors that carry the TP53 Y220C mutation, a specific change in one of the most frequently altered genes in cancer.
By using FoundationOne®CDx to detect the TP53 Y220C mutation, doctors can better identify patients who may benefit from rezatapopt. The TP53 Y220C mutation creates a vulnerable pocket in the p53 protein, making it unstable and affecting its tumor-suppressing function. This collaboration could lead to more precise treatment decisions and a new therapeutic option for patients with a high unmet medical need.
Read Announcement
PMV Pharmaceuticals FDA Events - Frequently Asked Questions
As of now, PMV Pharmaceuticals (PMVP) has not received any FDA approvals for its therapy in the last two years.
In the past two years, PMV Pharmaceuticals (PMVP) has reported FDA regulatory activity for rezatapopt.
The most recent FDA-related event for PMV Pharmaceuticals occurred on September 10, 2025, involving rezatapopt. The update was categorized as "Interim Data," with the company reporting: "PMV Pharmaceuticals, announced interim data from the Phase 2 pivotal portion of 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."
Currently, PMV Pharmaceuticals has one therapy (rezatapopt) targeting the following condition: in patients with advanced solid tumors.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:PMVP) was last updated on 9/13/2025 by MarketBeat.com Staff
Free PMVP Stock Alerts