PMV Pharma plans 2027 NDA after ovarian data

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.

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.

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

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

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.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 08/31/2026 - 04:08 PM EDT Accepted by SEC EDGAR 08/31/2026 - 04:06 PM EDT Learn about SEC filing dates

false 0001699382 0001699382 2026-08-31 2026-08-31

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): August 31, 2026

PMV Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware		001-39539		46-3218129
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)

400 Alexander Park Drive,
Suite 301
Princeton, NJ				08540
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (609) 642-6670

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock, $0.00001 par value per share		PMVP		The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 8.01 Other Events.

On August 31, 2026, PMV Pharmaceuticals, Inc. (the “Company”) issued a press release announcing updated rezatapopt monotherapy interim ovarian cancer data from the Phase 2 pivotal portion of the PYNNACLE clinical trial (the “Press Release”). The Press Release is attached hereto as Exhibit 99.1 and is incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits:

Exhibit Number		Description
99.1		Press Release, dated August 31, 2026.
104		Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

				PMV Pharmaceuticals, Inc.
Date: August 31, 2026				By:		/s/ Michael Carulli
						Michael Carulli
						Chief Financial Officer (Principal Financial and Accounting Officer)

Exhibit 99.1

PMV Pharmaceuticals Announces Updated Promising Rezatapopt Monotherapy Interim Ovarian Cancer Data From PYNNACLE Phase 2 Pivotal Trial

• 46% ORR observed among 76 evaluable patients in the ovarian cancer cohort with a median duration of response of 10.0 months

• Recent FDA interaction supports NDA submission strategy for accelerated approval of rezatapopt for platinum-resistant/refractory ovarian cancer, with submission planned in first quarter of 2027

• PMV plans to provide an update on all PYNNACLE Phase 2 pivotal trial cohorts at a medical conference in fourth quarter of 2026

PRINCETON, N.J., August 31, 2026 (GLOBE NEWSWIRE) — PMV Pharmaceuticals, Inc. (“PMV Pharma” or the “Company”; Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule therapies targeting p53, today announced updated interim ovarian cancer data from the Phase 2 pivotal portion of the PYNNACLE clinical trial. The multicenter, single-arm, registrational Phase 2 trial is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors.

Enrollment of platinum-resistant/refractory ovarian cancer patients for the primary analysis in the Phase 2 monotherapy portion of the PYNNACLE Phase 2 pivotal trial has been completed. The Company plans to provide an update on all PYNNACLE Phase 2 pivotal trial cohorts at a medical conference in the fourth quarter of 2026, including the primary analysis data from the ovarian cancer cohort.

PYNNACLE Phase 2 Ovarian Cancer Interim Data Update

The updated interim ovarian cancer data below are summarized as of a May 14, 2026 data cutoff date.

Efficacy

• The efficacy population consisted of 76 patients enrolled as of the data cutoff date who either had ≥1 post-baseline tumor assessment or discontinued early.

• Overall response rate (ORR) of 46% (35/76 patients, including four confirmed complete responses, 29 confirmed partial responses, and two unconfirmed partial responses) per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

• The median time to response was 1.3 months and median duration of response was 10.0 months, based on confirmed responses only.

Safety

Rezatapopt continues to show a favorable and consistent safety and tolerability profile across all cohorts, with mostly Grade 1 and 2 treatment-related adverse events (AEs) observed as well as a low rate (5%) of discontinuation due to treatment-related AEs. The safety and tolerability profile of rezatapopt in the ovarian cancer cohort was similar to the overall population.

Regulatory Update

In a recent meeting with the U.S. Food and Drug Administration (FDA), the Company obtained feedback that continues to support its strategy for submitting a New Drug Application (NDA) for accelerated approval of rezatapopt in patients with platinum-resistant/refractory ovarian cancer with a TP53 Y220C mutation based on the Phase 2 portion of the PYNNACLE clinical trial. The Company anticipates submitting an NDA in the first quarter of 2027.

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 and Orphan Drug Designation for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer.

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, conducted across approximately 70 sites.

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 therapies targeting p53. TP53 mutations are found in approximately half of all cancers. Our 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.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the Company’s future plans or expectations for rezatapopt, including the Company’s ability

to obtain approval as a treatment option as a monotherapy, expectations regarding timing, enrollment status and success of the Phase 2 portion of the current clinical trial for rezatapopt and the timing of a filing of a New Drug Application (NDA) for platinum-resistant/refractory ovarian cancer, the expectations and timing regarding receipt and disclosures of data results from clinical trials, the adequacy of the data from clinical trials to support proof-of-concept and/or the Company’s pursuit of regulatory approval of a NDA, the benefits of FDA’s grant of Orphan Drug Designation (ODD) for rezatapopt, and the timing and expectations with respect to the Company’s projected cash runway. Any forward-looking statements in this statement are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost, and timing of the Company’s product candidate development activities, including the successful filing of NDAs, and planned clinical trials, the Company’s ability to execute on its strategy and operate as a clinical stage company, the potential for clinical trials of rezatapopt or any future clinical trials of other product candidates to differ from preclinical, preliminary or expected results, maintenance by the Company of ODD status and related benefits for rezatapopt, the Company’s ability to fund operations, and the impact that a global pandemic, other public health emergencies or geopolitical tensions or conflicts may have on the Company’s clinical trials, supply chain, and operations, as well as those risks and uncertainties set forth in the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on March 6, 2026, most recent Quarterly Report on Form 10-Q, filed with the SEC on August 14, 2026, and its other filings filed with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Contacts

Investors Contact:

Tim Smith

Senior Vice President, Head of Corporate Development and Investor Relations

investors@pmvpharma.com

Media Contact:

Kathy Vincent

Greig Communications

kathy@greigcommunications.com

Filing Exhibits & Attachments

4 documents

Press Releases

• EX-99.1 EX-99.1 15.5 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA 3.1 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE 17.6 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE 11.0 KB