Pmv Pharmaceuticals Stock Price, News & Analysis

PMV Pharmaceuticals, Inc. (PMVP) is a clinical-stage precision oncology company that focuses on the discovery and development of small molecule, tumor-agnostic therapies targeting p53. According to multiple company disclosures, PMV Pharma is advancing drug candidates that are designed to address cancers driven by specific TP53 mutations, which are described as being found in approximately half of all cancers. The company’s common stock trades on the Nasdaq Global Select Market under the symbol PMVP, and PMV Pharma is headquartered in Princeton, New Jersey.

Business focus and scientific foundation

PMV Pharma describes itself as pioneering the discovery and development of small molecule therapies that target p53, a key tumor suppressor protein. The company’s co-founder, Dr. Arnold Levine, is credited in its public communications with establishing the field of p53 biology through the discovery of the p53 protein in 1979. PMV Pharma states that it brings together leaders in the field and utilizes more than four decades of p53 biology, combining this biological understanding with a pharmaceutical development focus.

The company’s approach is centered on precision oncology and tumor-agnostic development, meaning its investigational therapies are being studied across multiple tumor types that share a defined molecular alteration, rather than being limited to a single anatomical cancer type. Public materials repeatedly describe PMV Pharma as a precision oncology clinical-stage company, reflecting that its lead programs are in human clinical trials rather than commercialized.

Lead program: rezatapopt (PC14586)

Across its news releases and regulatory filings, PMV Pharma identifies rezatapopt (PC14586) as its lead product candidate. Rezatapopt is described as a first-in-class, small molecule p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein and restore wild-type tumor-suppressor function. Company communications note that the U.S. Food and Drug Administration has granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a TP53 Y220C mutation.

Rezatapopt is being evaluated primarily in the ongoing PYNNACLE clinical trial, a Phase 1/2 study in patients with advanced solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion was designed to determine the maximum tolerated dose and recommended Phase 2 dose when rezatapopt is administered orally, while also assessing safety, tolerability, pharmacokinetics, and biomarker effects. Company updates report that in Phase 1, an overall response rate was observed at the recommended Phase 2 dose in patients with TP53 Y220C and KRAS wild-type tumors, with a reported median duration of response of several months.

PYNNACLE Phase 2 trial design

PMV Pharma describes the Phase 2 monotherapy portion of PYNNACLE as a multicenter, single-arm, registrational, tumor-agnostic trial. It is assessing rezatapopt as monotherapy at a once-daily oral dose in patients with TP53 Y220C and KRAS wild-type advanced solid tumors. The Phase 2 portion is structured as an expansion basket trial comprising five cohorts: ovarian, lung, breast, endometrial cancers, and other solid tumors. The primary objective of the Phase 2 portion is to evaluate the efficacy of rezatapopt at the recommended Phase 2 dose, with overall response rate per blinded independent central review identified as the primary endpoint in company disclosures.

PMV Pharma has reported interim and updated Phase 2 data from PYNNACLE, including overall response rates and median duration of response across multiple tumor types such as ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder cancers, and ampullary carcinoma in patients whose tumors are TP53 Y220C mutated and KRAS wild-type. These results have been presented in oral and poster formats at oncology and clinical pharmacology conferences, and summarized in press releases and in an investor webinar referenced in an 8-K filing.

Clinical-stage pipeline and collaborations

In addition to the PYNNACLE trial in solid tumors, PMV Pharma has disclosed a collaboration with MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center to support an investigator-initiated Phase 1b study. This study is designed to evaluate rezatapopt as monotherapy and in combination with azacitidine in patients with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) harboring a TP53 Y220C mutation. The study is intended to assess safety, tolerability, pharmacokinetics, and preliminary efficacy in this hematologic setting.

Company communications also describe prior work with combination regimens. For example, PMV Pharma has reported that dose-limiting toxicities were observed in a combination arm of the Phase 1b PYNNACLE trial evaluating rezatapopt with Merck’s anti-PD-1 therapy pembrolizumab (KEYTRUDA). At a defined dose level, this combination was established as the maximum tolerated dose, but due to limited clinical benefit at that dose, PMV Pharma discontinued enrollment in the combination arm. The company has also noted a collaboration with Foundation Medicine to develop a tissue-based comprehensive genomic profiling test as a companion diagnostic for rezatapopt.

Scientific publications and data presentations

PMV Pharma highlights several scientific outputs related to rezatapopt and p53 targeting. The company has cited publications in journals such as Cancer Discovery and ACS Medicinal Chemistry Letters that describe the discovery of rezatapopt and the restoration of tumor suppressor function of the Y220C-mutant p53 protein by the molecule. Data from the PYNNACLE trial have been presented at meetings including the Society for Gynecologic Oncology Annual Meeting on Women’s Cancer, the San Antonio Breast Cancer Symposium, the American College of Clinical Pharmacology Annual Conference, and the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.

In its communications, PMV Pharma emphasizes that TP53 mutations are prevalent across cancers and that patients with TP53 Y220C-mutated advanced solid tumors can have poor prognoses and reduced overall survival compared to patients without this mutation, as summarized in a real-world study presented in poster form. This context underpins the company’s focus on therapies that are designed to reactivate mutant p53 proteins.

Regulatory status and development stage

Based on its public disclosures, PMV Pharma remains a clinical-stage company without approved commercial products. The company repeatedly describes rezatapopt as an investigational therapy and outlines plans and expectations around clinical trial enrollment, interim analyses, and potential New Drug Application submissions in its forward-looking statements. These plans include a focus on platinum-resistant or refractory ovarian cancer within the broader tumor-agnostic strategy for TP53 Y220C and KRAS wild-type tumors.

PMV Pharma’s disclosures also note that rezatapopt has received FDA Fast Track designation for locally advanced or metastatic solid tumors with a TP53 Y220C mutation. Fast Track designation is referenced in multiple press releases describing the PYNNACLE trial and the mechanism of action of rezatapopt as a p53 reactivator.

Financial reporting and SEC filings

PMV Pharmaceuticals files periodic financial statements and current reports with the U.S. Securities and Exchange Commission. Recent Form 8-K filings reference press releases announcing quarterly financial results and corporate updates, as well as interim clinical data and investor presentations. These filings confirm that PMV Pharma’s common stock is registered under Section 12(b) of the Exchange Act and listed on the Nasdaq Global Select Market under the trading symbol PMVP.

Across its financial updates, the company reports operating expenses primarily driven by research and development activities related to rezatapopt and general and administrative costs. It also discloses cash, cash equivalents, and marketable securities balances, and provides commentary on expected cash runway based on these resources. These details illustrate that PMV Pharma is funding ongoing clinical development and related operations as a clinical-stage precision oncology company.

Headquarters and corporate identity

In its press releases and SEC filings, PMV Pharma consistently states that it is headquartered in Princeton, New Jersey. The company identifies itself as PMV Pharmaceuticals, Inc., often abbreviated as PMV Pharma, and characterizes its mission as combining deep p53 biology with pharmaceutical development to advance targeted therapies for patients with cancers driven by TP53 mutations.

FAQs about PMV Pharmaceuticals, Inc. (PMVP)

• What does PMV Pharmaceuticals, Inc. do?
  

  PMV Pharma is a precision oncology clinical-stage company focused on discovering and developing small molecule, tumor-agnostic therapies targeting p53. Its public materials emphasize the development of investigational therapies for cancers driven by specific TP53 mutations.

• What is PMV Pharma’s lead drug candidate?
  

  The company identifies rezatapopt (PC14586) as its lead product candidate. Rezatapopt is described as a first-in-class, small molecule p53 reactivator designed to selectively bind to the pocket in the p53 Y220C mutant protein and restore wild-type tumor-suppressor function.

• Which mutation does rezatapopt target?
  

  Rezatapopt is being developed for tumors harboring the TP53 Y220C mutation. Company disclosures state that the molecule is designed to bind selectively to the p53 Y220C mutant protein and that the PYNNACLE trial enrolls patients with advanced solid tumors with a TP53 Y220C mutation, often further specified as TP53 Y220C and KRAS wild-type in the Phase 2 portion.

• What is the PYNNACLE clinical trial?
  

  PYNNACLE is an ongoing Phase 1/2 clinical trial evaluating rezatapopt in patients with advanced solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion was designed to determine the maximum tolerated dose and recommended Phase 2 dose and to assess safety, tolerability, pharmacokinetics, and biomarker effects. The Phase 2 portion is described as a registrational, single-arm, expansion basket trial with five cohorts across ovarian, lung, breast, endometrial cancers, and other solid tumors.

• Has rezatapopt received any FDA designations?
  

  Yes. PMV Pharma reports that the U.S. Food and Drug Administration has granted Fast Track designation to rezatapopt for the treatment of patients with locally advanced or metastatic solid tumors with a TP53 Y220C mutation.

• Is PMV Pharma a commercial-stage company?
  

  No. In its public communications, PMV Pharma describes itself as a clinical-stage company. Its lead candidate rezatapopt is referred to as an investigational therapy, and the company’s activities are centered on clinical trials and development rather than marketed products.

• On which exchange does PMV Pharma trade and what is its ticker symbol?
  

  According to its SEC filings, PMV Pharmaceuticals, Inc. has its common stock listed on the Nasdaq Global Select Market under the trading symbol PMVP.

• Where is PMV Pharma headquartered?
  

  Company press releases and filings state that PMV Pharma is headquartered in Princeton, New Jersey.

• Does PMV Pharma work with external partners or institutions?
  

  Yes. PMV Pharma has disclosed collaborations with MD Anderson Cancer Center and Memorial Sloan Kettering Cancer Center on an investigator-initiated Phase 1b study in relapsed or refractory AML/MDS with TP53 Y220C mutation, and a partnership with Foundation Medicine to develop a companion diagnostic test for rezatapopt.

• What is the significance of TP53 mutations in PMV Pharma’s strategy?
  

  Company materials highlight that TP53 mutations are found in approximately half of all cancers. PMV Pharma’s strategy centers on developing small molecule therapies that target specific mutant forms of p53, such as TP53 Y220C, with the goal of restoring tumor-suppressor function in cancers driven by these mutations.