PMV Pharmaceuticals (PMVP) FDA Approvals $1.28 -0.03 (-1.91%) As of 02:30 PM Eastern This is a fair market value price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock 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. DrugTarget DateAnnouncement rezatapoptQ1 2027NDA FilingPMV Pharmaceuticals, announced that (October 24, 2025) PMV Pharmaceuticals' Drug in the FDA Approval ProcessThis 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. NDA Filing - October 24,2025Nda Filing NDADrug: rezatapoptAnnounced Date: October 24, 2025Target Action Date: Q1 2027Estimated Target Date Range: January 1, 2027 - March 31, 2027Indication: in patients with advanced solid tumorsAnnouncementPMV Pharmaceuticals, announced thatAI SummaryPMV 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 AnnouncementUpdated data - October 24,2025Updated Data Phase 2Drug: rezatapoptAnnounced Date: October 24, 2025Indication: in patients with advanced solid tumorsAnnouncementPMV Pharmaceuticals, announced that announced updated data from the Phase 2 pivotal portion of the ongoing PYNNACLE clinical trial.AI SummaryPMV 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 AnnouncementAbstract Presentation - October 13,2025Abstract Presentation Drug: rezatapoptAnnounced Date: October 13, 2025Indication: in patients with advanced solid tumorsAnnouncementPMV 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 SummaryPMV 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 AnnouncementInterim Data - September 10,2025Interim Data Phase 2Drug: rezatapoptAnnounced Date: September 10, 2025Indication: in patients with advanced solid tumorsAnnouncementPMV 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 SummaryPMV 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 AnnouncementProvided Update - May 29,2024Provided Update Drug: rezatapoptAnnounced Date: May 29, 2024Indication: in patients with advanced solid tumorsAnnouncementFoundation 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 SummaryFoundation 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 Has PMV Pharmaceuticals received FDA approval? As of now, PMV Pharmaceuticals (PMVP) has not received any FDA approvals for its therapy in the last two years. What drugs has PMV Pharmaceuticals submitted to the FDA? In the past two years, PMV Pharmaceuticals (PMVP) has reported FDA regulatory activity for rezatapopt. What is the most recent FDA event for PMV Pharmaceuticals? 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." What conditions do PMV Pharmaceuticals' current drugs treat? Currently, PMV Pharmaceuticals has one therapy (rezatapopt) targeting the following condition: in patients with advanced solid tumors. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Adagio Medical FDA EventsBioCardia FDA EventsCognition Therapeutics FDA EventsCorbus Pharmaceuticals FDA EventsPrecision BioSciences FDA EventsHUTCHMED FDA EventsEli Lilly and Company FDA EventsTeleflex FDA EventsBioMarin Pharmaceutical FDA EventsDiaMedica Therapeutics FDA EventsDyne Therapeutics FDA EventsGuardant Health FDA EventsLigand Pharmaceuticals FDA EventsMadrigal Pharmaceuticals FDA EventsMetaVia FDA Events 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 Related Companies Prelude Therapeutics FDA Events Editas Medicine FDA Events ALX Oncology FDA Events Entrada Therapeutics FDA Events MacroGenics FDA Events Artiva Biotherapeutics FDA Events Minerva Neurosciences FDA Events Voyager Therapeutics FDA Events Alector FDA Events Whitehawk Therapeutics FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:PMVP last updated on 10/24/2025 by MarketBeat.com Staff. 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NDA Filing - October 24,2025Nda Filing NDADrug: rezatapoptAnnounced Date: October 24, 2025Target Action Date: Q1 2027Estimated Target Date Range: January 1, 2027 - March 31, 2027Indication: in patients with advanced solid tumorsAnnouncementPMV Pharmaceuticals, announced thatAI SummaryPMV 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
Updated data - October 24,2025Updated Data Phase 2Drug: rezatapoptAnnounced Date: October 24, 2025Indication: in patients with advanced solid tumorsAnnouncementPMV Pharmaceuticals, announced that announced updated data from the Phase 2 pivotal portion of the ongoing PYNNACLE clinical trial.AI SummaryPMV 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
Abstract Presentation - October 13,2025Abstract Presentation Drug: rezatapoptAnnounced Date: October 13, 2025Indication: in patients with advanced solid tumorsAnnouncementPMV 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 SummaryPMV 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
Interim Data - September 10,2025Interim Data Phase 2Drug: rezatapoptAnnounced Date: September 10, 2025Indication: in patients with advanced solid tumorsAnnouncementPMV 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 SummaryPMV 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
Provided Update - May 29,2024Provided Update Drug: rezatapoptAnnounced Date: May 29, 2024Indication: in patients with advanced solid tumorsAnnouncementFoundation 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 SummaryFoundation 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
