PMV Pharmaceuticals announces oral presentation of rezatapopt data at AACR-NCI-EORTC conference, targeting TP53 Y220C mutation in advanced tumors.
Quiver AI Summary
PMV Pharmaceuticals announced that initial data from its ongoing pivotal Phase 2 study of rezatapopt, a precision oncology therapy targeting the TP53 Y220C mutation in advanced solid tumors, will be presented at the AACR-NCI-EORTC International Conference from October 22-26, 2025 in Boston. The company will feature an oral presentation detailing the study's analysis, led by Dr. Alison M. Schram from Memorial Sloan Kettering Cancer Center, along with two poster presentations on related topics. Rezatapopt is designed to reactivate p53 function in tumors with specific mutations, and the study aims to evaluate its efficacy in various cancer types. The U.S. FDA has granted Fast Track designation for this drug in treating locally advanced or metastatic solid tumors with the TP53 Y220C mutation.
Potential Positives
- Two abstracts accepted for presentation at a significant international conference, showcasing the company’s research and development efforts in precision oncology.
- Oral presentation highlights initial data from a pivotal Phase 2 study of rezatapopt, potentially signaling progress in clinical development and increased visibility for PMV Pharma.
- Rezatapopt receives Fast Track designation from the FDA, indicating the therapy's potential to address an unmet medical need in patients with specific advanced solid tumors.
Potential Negatives
- The press release focuses heavily on the initial data from an ongoing clinical trial, which may suggest that conclusive results or efficacy data are still pending, potentially indicating a lack of immediate success for the therapy.
- While the FDA has granted Fast Track designation, such designations do not guarantee eventual approval or market success, presenting an uncertainty regarding the therapy's future.
- The Phase 2 trial being a single-arm study may raise concerns about the robustness of the results, as there is no control group for comparison.
FAQ
What is rezatapopt and its significance in cancer treatment?
Rezatapopt is a first-in-class precision oncology therapy targeting TP53 Y220C mutations to reactivate tumor-suppressor p53 functions.
When will the oral presentation on rezatapopt take place?
The oral presentation is scheduled for October 24, 2025, from 10:00 – 11:40 AM ET at the AACR-NCI-EORTC Conference.
What is the focus of the ongoing PYNNACLE clinical trial?
The PYNNACLE trial focuses on evaluating the efficacy and safety of rezatapopt in patients with advanced tumors carrying the TP53 Y220C mutation.
Where can I find more information about the Phase 1/2 PYNNACLE trial?
More information can be found on clinicaltrials.gov using the trial identifier NCT04585750.
Who are the key stakeholders behind PMV Pharma?
PMV Pharma was co-founded by Dr. Arnold Levine, a pioneer in p53 biology, and focuses on p53-targeted oncology therapies.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$PMVP Insider Trading Activity
$PMVP insiders have traded $PMVP stock on the open market 5 times in the past 6 months. Of those trades, 0 have been purchases and 5 have been sales.
Here’s a breakdown of recent trading of $PMVP stock by insiders over the last 6 months:
- ADVISORS LLC ORBIMED sold 500,000 shares for an estimated $900,000
- DAVID HENRY MACK (President and CEO) sold 58,411 shares for an estimated $62,178
- DEEPIKA JALOTA (Chief Development Officer) sold 33,065 shares for an estimated $35,197
- MICHAEL CARULLI (Chief Financial Officer) sold 28,249 shares for an estimated $30,076
- ROBERT TICKTIN (General Counsel & COO) sold 23,151 shares for an estimated $24,651
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$PMVP Hedge Fund Activity
We have seen 20 institutional investors add shares of $PMVP stock to their portfolio, and 29 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- PFM HEALTH SCIENCES, LP removed 3,301,942 shares (-100.0%) from their portfolio in Q2 2025, for an estimated $3,500,058
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- CONNOR, CLARK & LUNN INVESTMENT MANAGEMENT LTD. removed 267,636 shares (-100.0%) from their portfolio in Q2 2025, for an estimated $283,694
- CITADEL ADVISORS LLC added 242,311 shares (+1716.1%) to their portfolio in Q2 2025, for an estimated $256,849
- STONEPINE CAPITAL MANAGEMENT, LLC added 215,785 shares (+34.2%) to their portfolio in Q2 2025, for an estimated $228,732
- ASSENAGON ASSET MANAGEMENT S.A. removed 139,967 shares (-53.2%) from their portfolio in Q3 2025, for an estimated $195,953
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Full Release
- Oral presentation to highlight initial data from ongoing pivotal Phase 2 study of rezatapopt, a first-in-class precision oncology investigational therapy, in patients with advanced solid tumors harboring a TP53 Y220C mutation
PRINCETON, N.J., Oct. 13, 2025 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53, today 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.
Details for the presentations are as follows:
Oral Presentation
Title:
Rezatapopt for locally advanced or metastatic solid tumors with a TP53 Y220C mutation: Initial analysis of the pivotal PYNNACLE Phase 2 trial
Date and Time:
Friday, October 24; 10:00 – 11:40 AM ET
Session and Location:
Clinical Trials Plenary Session; Level 3, Ballroom AB
Presenter:
Alison M. Schram, M.D., Memorial Sloan Kettering Cancer Center
Poster Presentations
Title:
Rezatapopt for locally advanced or metastatic solid tumors with a TP53 Y220C mutation: Initial analysis of the pivotal PYNNACLE Phase 2 trial
Date and Time:
Friday, October 24; 12:30 – 4:00 PM ET
Session and Location:
Poster Session B; Exhibit Hall D
Title:
Natural history and prognostic value of TP53 Y220C mutation in advanced solid tumors: A real-world study
Date and Time:
Saturday, October 25; 12:30 – 4:00 PM ET
Session and Location:
Poster Session C; Exhibit Hall D
About Rezatapopt
Rezatapopt (PC14586) is a first-in-class, small molecule, p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein, restoring the wild-type tumor-suppressor function. The U.S. Food and Drug Administration granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a p53 Y220C mutation.
About 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. The primary objective of the Phase 1 portion of the clinical trial was to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D) of rezatapopt when administered orally to patients. Safety, tolerability, pharmacokinetics, and effects on biomarkers were also assessed. The Phase 2 portion is a registrational, single arm, expansion basket clinical trial comprising five cohorts (ovarian, lung, breast, and endometrial cancers, and other solid tumors) with the primary objective of evaluating the efficacy of rezatapopt at the RP2D in patients with
TP53
Y220C and KRAS wild-type advanced solid tumors. For more information about the Phase 1/2 PYNNACLE clinical trial, refer to www.clinicaltrials.gov (NCT trial identifier NCT04585750).
About PMV Pharma
PMV Pharma is a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53.
TP53
mutations are found in approximately half of all cancers. The Company’s co-founder, Dr. Arnold Levine, established the field of p53 biology when he discovered the p53 protein in 1979. Bringing together leaders in the field to utilize more than four decades of p53 biology, PMV Pharma combines unique biological understanding with a pharmaceutical development focus. PMV Pharma is headquartered in Princeton, New Jersey. For more information, please visit
www.pmvpharma.com
.
Contacts
Investors Contact:
Tim Smith
Senior Vice President, Head of Corporate Development and Investor Relations
[email protected]
Media Contact:
Kathy Vincent
Greig Communications
[email protected]
