PMV Pharma (NASDAQ: PMVP) plans 2027 NDA after ovarian cancer trial update
Rhea-AI Filing Summary
PMV Pharmaceuticals, Inc. (PMVP) reported updated interim ovarian cancer data from the Phase 2 pivotal portion of its registrational PYNNACLE trial of rezatapopt monotherapy in TP53 Y220C advanced solid tumors. The trial uses a 2000 mg once-daily oral dose and includes platinum-resistant/refractory ovarian cancer patients, for whom enrollment for the primary analysis has been completed.
As of a May 14, 2026 data cutoff, rezatapopt continued to show a favorable and consistent safety and tolerability profile across cohorts, with mostly Grade 1–2 treatment-related adverse events and a 5% discontinuation rate due to treatment-related events; the ovarian cancer cohort safety profile was similar to the overall population. PMV Pharma received FDA feedback that continues to support its strategy to seek accelerated approval for rezatapopt in platinum-resistant/refractory TP53 Y220C ovarian cancer based on the Phase 2 portion of PYNNACLE and anticipates submitting a New Drug Application in the first quarter of 2027. The company plans to present updated data from all Phase 2 pivotal cohorts, including primary analysis data from the ovarian cohort, at a medical conference in the fourth quarter of 2026.
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8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Rezatapopt dose: 2000 mg once-daily
Discontinuation rate: 5%
Data cutoff date: May 14, 2026
+5 more
8 metrics
Rezatapopt dose
2000 mg once-daily
Monotherapy dose in Phase 2 pivotal PYNNACLE trial
Discontinuation rate
5%
Discontinuation due to treatment-related adverse events across cohorts as of May 14, 2026
Data cutoff date
May 14, 2026
Cutoff for updated interim ovarian cancer data
Planned NDA timing
First quarter of 2027
Expected submission of NDA for platinum-resistant/refractory TP53 Y220C ovarian cancer
Planned data update timing
Fourth quarter of 2026
Medical conference update for all PYNNACLE Phase 2 pivotal cohorts
Number of Phase 2 cohorts
5 cohorts
Ovarian, lung, breast, endometrial, and other solid tumors
Trial sites
Approximately 70 sites
Sites participating in the Phase 2 portion of PYNNACLE
TP53 mutation prevalence
Approximately half of all cancers
Frequency of TP53 mutations cited by PMV Pharma
Key Terms
accelerated approval, Fast Track designation, Orphan Drug Designation, registrational Phase 2 trial, +2 more
6 terms
accelerated approval regulatory
"strategy for submitting a New Drug Application (NDA) for accelerated approval of rezatapopt"
Accelerated approval is a process that allows new medical treatments to be approved more quickly than usual if they address serious or life-threatening conditions and show promising early results. For investors, it signals that a treatment may reach the market sooner, potentially boosting a company's prospects, but it also involves some uncertainty since full evidence of effectiveness is still being gathered.
Fast Track designation regulatory
"The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt"
Fast track designation is a status the U.S. Food and Drug Administration grants to drugs intended to treat serious conditions and address an unmet medical need. It gives the developer more frequent communication with the FDA and can allow parts of the application to be reviewed on a rolling basis, and it may pave the way to priority review or accelerated approval. It can shorten development timelines, though it does not guarantee approval.
Orphan Drug Designation regulatory
"granted Fast Track designation to rezatapopt ... and Orphan Drug Designation for the treatment"
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
registrational Phase 2 trial medical
"The multicenter, single-arm, registrational Phase 2 trial is assessing rezatapopt"
basket clinical trial medical
"Phase 2 portion is a registrational, single arm, expansion basket clinical trial"
A basket clinical trial tests a single treatment across multiple patient groups that have different diseases but share a common biological feature, such as the same genetic mutation. Like trying one key in several different locks that use the same cut, it can show whether a drug works broadly or only in specific groups, which matters to investors because positive results can expand the potential market and shorten development time, while negative results can limit expected returns.
p53 reactivator medical
"Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator"
FAQ
What did PMVP announce about the PYNNACLE Phase 2 ovarian cancer data?
PMV Pharmaceuticals announced updated interim ovarian cancer data from the Phase 2 pivotal portion of the PYNNACLE trial of rezatapopt monotherapy. As of a May 14, 2026 cutoff, the company highlighted a favorable safety profile, with mostly Grade 1–2 treatment-related adverse events and 5% discontinuations.
What dose of rezatapopt is being used in PMVP’s PYNNACLE trial?
Rezatapopt is being evaluated as monotherapy in the PYNNACLE registrational Phase 2 trial at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors, including platinum-resistant/refractory ovarian cancer.
When does PMVP expect to present full Phase 2 pivotal data for PYNNACLE?
PMV Pharmaceuticals plans to provide an update on all PYNNACLE Phase 2 pivotal trial cohorts, including primary analysis data from the ovarian cancer cohort, at a medical conference in the fourth quarter of 2026.
When does PMVP plan to submit an NDA for rezatapopt in ovarian cancer?
Following FDA feedback that supports its strategy, PMV Pharmaceuticals anticipates submitting a New Drug Application for rezatapopt in platinum-resistant/refractory TP53 Y220C ovarian cancer in the first quarter of 2027, based on data from the Phase 2 portion of the PYNNACLE trial.
What regulatory designations has rezatapopt received according to PMVP?
Rezatapopt has received Fast Track designation from the FDA for locally advanced or metastatic solid tumors with a p53 Y220C mutation and Orphan Drug Designation for TP53 Y220C positive ovarian, fallopian tube, and primary peritoneal cancers.
How large is the PYNNACLE trial program described by PMVP?
The ongoing Phase 1/2 PYNNACLE trial is a multicenter, single-arm, registrational study conducted across approximately 70 sites, with a Phase 2 expansion basket comprising five cohorts: ovarian, lung, breast, endometrial cancers, and other solid tumors harboring TP53 Y220C.
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