Upcoming FDA Events for PMV Pharmaceuticals
PMV Pharmaceuticals (PMVP) has upcoming FDA regulatory milestones for rezatapopt. The table below outlines estimated target dates and event types for these pending regulatory actions.
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 Timeline and 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:
- October 24, 2025
- Target Action Date:
- Q1 2027
- Estimated Target Date Range:
- January 1, 2027 - March 31, 2027
- Indication:
- in patients with advanced solid tumors
Announcement
PMV Pharmaceuticals, announced that
AI Summary
PMV Pharmaceuticals announced updated results from the Phase 2 portion of its PYNNACLE clinical trial evaluating rezatapopt in patients with advanced solid tumors carrying a TP53 Y220C mutation. The data were presented at the 2025 AACR-NCI-EORTC conference in Boston.
Across eight solid tumor types, including ovarian, lung and breast cancers, the trial showed a 34% overall response rate among 103 evaluable patients. In the ovarian cohort (48 patients), the ORR was 46%. The median duration of response was 7.6 months overall and 8.0 months in ovarian cancer.
Rezatapopt was generally well tolerated. Most side effects were mild or moderate, such as nausea and fatigue. Grade 3 events were rare, resolved during treatment, and caused a 3.6% discontinuation rate. PMV Pharma plans to submit a New Drug Application for platinum-resistant or refractory ovarian cancer in the first quarter of 2027.
Read Announcement- Drug:
- rezatapopt
- Announced Date:
- October 24, 2025
- Indication:
- in patients with advanced solid tumors
Announcement
PMV Pharmaceuticals, announced that announced updated data from the Phase 2 pivotal portion of the ongoing PYNNACLE clinical trial.
AI Summary
PMV Pharmaceuticals announced updated Phase 2 pivotal data from its ongoing PYNNACLE clinical trial of rezatapopt, a small molecule therapy for tumors with a TP53 Y220C mutation. In an oral presentation at the 2025 AACR-NCI-EORTC conference, investigators reported a 34% overall response rate (ORR) among 103 evaluable patients, with a median duration of response of 7.6 months.
The ovarian cancer cohort showed particularly strong activity, with a 46% ORR in 48 patients, including one confirmed complete response and multiple partial responses, and a median response duration of 8.0 months. Confirmed responses were also seen in lung, breast, endometrial, head and neck, colorectal, gallbladder and ampullary cancers.
Rezatapopt was generally well tolerated. Most treatment-related side effects were mild or moderate, such as nausea, fatigue and lab abnormalities. Serious events were uncommon and manageable, and few patients discontinued treatment due to adverse events.
PMV Pharma plans to submit a New Drug Application in the first quarter of 2027 for platinum-resistant or refractory ovarian cancer based on these results.
Read Announcement- Drug:
- rezatapopt
- Announced Date:
- October 13, 2025
- Indication:
- in patients with advanced solid tumors
Announcement
PMV Pharmaceuticals, Inc. announced that two abstracts have been accepted for oral and poster presentations at the upcoming AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics being held October 22-26, 2025 in Boston, MA.
AI Summary
PMV Pharmaceuticals announced that two abstracts have been accepted for presentations at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, taking place October 22–26, 2025, in Boston, MA.
An oral presentation titled “Rezatapopt for locally advanced or metastatic solid tumors with a TP53 Y220C mutation: Initial analysis of the pivotal PYNNACLE Phase 2 trial” will be delivered by Alison M. Schram, M.D., on Friday, October 24, from 10:00 to 11:40 AM ET during the Clinical Trials Plenary Session in Ballroom AB, Level 3.
Two poster presentations will follow: the first on Friday, October 24 (12:30–4:00 PM ET, Poster Session B, Exhibit Hall D) covering initial Phase 2 data, and the second on Saturday, October 25 (12:30–4:00 PM ET, Poster Session C, Exhibit Hall D) detailing the natural history and prognostic value of the TP53 Y220C mutation in advanced solid tumors.
Read Announcement- 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 October 24, 2025, involving rezatapopt. The update was categorized as "Updated data," with the company reporting: "PMV Pharmaceuticals, announced that announced updated data from the Phase 2 pivotal portion of the ongoing PYNNACLE clinical trial."
Currently, PMV Pharmaceuticals has one therapy (rezatapopt) targeting the following condition: in patients with advanced solid tumors.
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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
FDA progress for NASDAQ:PMVP last updated on 10/24/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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