PMVP

Rezatapopt granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of TP53 Y220C positive ovarian cancer New England Journal of Medicine published first-in-human rezatapopt data showing selective reactivation of mutant p53 in advanced solid tumors Rezatapopt New Drug Application submission for platinum-resistant/refractory ovarian cancer planned in first quarter of 2027 Cash, cash equivalents, and marketable securities of $93.5 million as of March 31, 2026 providing expected cash runway to end of second quarter of 2027 PRINCETON, N.J., May 12, 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 reported financial results for the first quarter ended March 31, 2026, and provided a corporate update. “The first quarter was one of continued execution as we advance the PYNNACLE study and remain on track to target an NDA submission for rezatapopt for platinum-resistant/refractory ovarian cancer in the first quarter of 2027,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We are also encouraged by the publication of the PYNNACLE Phase 1 results in the New England Journal of Medicine, which underscores the scientific innovation behind rezatapopt and highlights its potential to address a significant unmet medical need. Patients with TP53 Y220C advanced solid tumors, including platinum resistant ovarian cancer, experience poor outcomes despite available therapies.” PYNNACLE Phase 2 Monotherapy Update: Enrollment is on track in the Phase 2 monotherapy portion of the PYNNACLE clinical trial. The multicenter, single-arm, registrational Phase 2 study is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors. PMV Pharma anticipates submitting a New Drug Application (NDA) for rezatapopt in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation in the first quarter of 2027. Corporate Highlights: Updated Phase 2 PYNNACLE clinical results evaluating rezatapopt were featured in an oral presentation at the 2026 Society of Gynecologic Oncology Annual Meeting on Women's Cancer on April 12, 2026. Confirmed responses were observed in platinum-resistant/refractory ovaria...

Enrollment remains on track in Phase 2 pivotal portion of PYNNACLE trial evaluating rezatapopt as monotherapy in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation Rezatapopt granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of TP53 Y220C positive ovarian cancer New England Journal of Medicine published first-in-human rezatapopt data showing selective reactivation of mutant p53 in advanced solid tumors Rezatapopt New Drug Application submission for platinum-resistant/refractory ovarian cancer planned in first quarter of 2027 Cash, cash equivalents, and marketable securities of $112.9 million as of December 31, 2025 providing expected cash runway to end of second quarter of 2027 PRINCETON, N.J., March 06, 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 reported financial results for the full year ended December 31, 2025, and provided a corporate update. “2025 was an important and productive year for PMV Pharma as we reported positive Phase 2 interim data from the registrational PYNNACLE clinical trial and made significant progress in enrolling the study,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We look forward to submitting an NDA in the first quarter of 2027 for rezatapopt in platinum-resistant/refractory ovarian cancer.” PYNNACLE Phase 2 Monotherapy Update: Enrollment is on track in the Phase 2 monotherapy portion of the PYNNACLE clinical trial. The multicenter, single-arm, registrational Phase 2 study is assessing rezatapopt as monotherapy at a dose of 2000 mg once-daily in patients with TP53 Y220C advanced solid tumors. PMV Pharma anticipates submitting a New Drug Application (NDA) for rezatapopt in platinum-resistant/refractory ovarian cancer patients with a TP53 Y220C mutation in the first quarter of 2027. Full Year 2025 and Recent Corporate Highlights: On March 2, 2026, the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to rezatapopt for the treatment of TP53 Y220C positive ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. The FDA provides ODD status to drugs intended for the safe and effective treatment, diagnosis, or prevention...

On February 2, BML Capital Management disclosed in a Securities and Exchange Commission filing that it sold out of Alumis (NASDAQ:ALMS), liquidating 1,210,415 shares in an estimated $4.83 million trade. According to a Securities and Exchange Commission (SEC) filing dated February 2, BML Capital Management reported a complete sale of its 1,210,415-share stake in Alumis (NASDAQ:ALMS). As a result, the fund's quarter-end position value in Alumis decreased by $4.83 million, and it now holds no shares. Top holdings after the filing: NASDAQ: ACRS: $42.89 million (38.0% of AUM) NASDAQ: AVIR: $26.74 million (23.7% of AUM) NASDAQ: ORMP: $9.03 million (8.0% of AUM) NASDAQ: TIL: $7.10 million (6.3% of AUM) NASDAQ: PMVP: $6.62 million (5.9% of AUM) As of February 2, shares of Alumis were priced at $26.42, up a staggering 255.1% over the prior year and well outperforming the S&P 500’s roughly 15% gain in the same period. Alumis develops clinical-stage therapies for autoimmune and neuroinflammatory disorders, including ESK-001 and A-005 targeting TYK2 inhibition. The company operates a biopharmaceutical business model focused on advancing proprietary drug candidates through clinical trials toward regulatory approval and commercialization. It targets patients with autoimmune diseases such as plaque psoriasis, systemic lupus erythematosus, and neurodegenerative conditions. Alumis is a clinical-stage biotechnology company specializing in the development of novel therapies for autoimmune and neuroinflammatory diseases. The company leverages expertise in TYK2 inhibition to advance a pipeline of differentiated drug candidates addressing significant unmet medical needs. With a focus on innovation and clinical rigor, Alumis seeks to establish a competitive position in the biopharmaceutical sector through targeted therapeutic development. BML Capital’s move is a reminder that even disciplined portfolio decisions can collide with fast-moving catalysts. The sale was completed by December 31, as of the filing’s period-end date, before Alumis announced its January upsized public offering and before shares went on to surge roughly 200% in the weeks that followed. At the time, the decision was defensible. Alumis was a clinical-stage biotech with no approved products and heavy R&D spend. As of the third quarter, the company reported $377.7 million in cash and marketable securities, but a...

Updated clinical results from Phase 2 pivotal portion of the PYNNACLE study evaluating rezatapopt featured in late-breaking oral presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 34% overall response rate (ORR) observed among 103 evaluable patients across all cohorts with a median duration of response of 7.6 months 46% ORR observed among 48 evaluable patients in ovarian cancer cohort with a median duration of response of 8.0 months Rezatapopt New Drug Application submission for platinum resistant/refractory ovarian cancer planned in first quarter of 2027 Cash, cash equivalents, and marketable securities of $129.3 million as of September 30, 2025, providing expected cash runway to end of first quarter of 2027 PRINCETON, N.J., Nov. 12, 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 therapies targeting p53, today reported financial results for the third quarter ended September 30, 2025, and provided a corporate update. “I am incredibly proud of our team and their commitment to rapidly and efficiently advancing the PYNNACLE study,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We are excited by the data emerging from this study and look forward to submitting an NDA in the first quarter of 2027 for platinum-resistant/refractory ovarian cancer.” Corporate Highlights Updated clinical results from the Phase 2 pivotal portion of the PYNNACLE study evaluating rezatapopt were featured in late-breaking oral and poster presentations at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on October 24, 2025. Confirmed responses were observed in patients whose tumors were TP53 Y220C mutated and KRAS wild-type in eight tumor types including ovarian, lung, breast, endometrial, head and neck, colorectal, gallbladder cancers, and ampullary carcinoma. Overall response rate (ORR) of 34% (35/103 patients) per investigator assessment according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including confirmed and unconfirmed responses. The cohort-specific ORRs were as follows: Ovarian cancer: 46% ORR (22/48 patients, including one confirmed complete response, 18 confirmed partial responses,...

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 ora...

PMV will host an investor webinar on Wednesday, September 10, 2025 at 8:00 AM ET to review Phase 2 PYNNACLE clinical trial interim analysis Interim analysis will include data for approximately 65 patients with at least 18 weeks of follow-up Cash, cash equivalents, and marketable securities of $148.3 million as of June 30, 2025, providing expected cash runway to end of 2026 PRINCETON, N.J., Aug. 07, 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 reported financial results for the second quarter ended June 30, 2025, and provided a corporate update. PMV Pharma will host an investor webinar on Wednesday, September 10, 2025 at 8:00 AM ET to review interim analysis data from the Phase 2 PYNNACLE clinical trial. This interim analysis will include data for approximately 65 patients who have had at least 18 weeks of follow-up, of which approximately 45% are in the ovarian cancer cohort. “Our team has continued to execute at an exceptionally high level as we advance the registrational Phase 2 PYNNACLE clinical trial,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “We look forward to providing data from the interim analysis on September 10.” Second Quarter 2025 Financial Results PMV Pharma ended the second quarter with $148.3 million in cash, cash equivalents, and marketable securities, compared to $165.8 million as of March 31, 2025. Net cash used in operations was $36.5 million for the six months ended June 30, 2025, compared to $17.8 million for the six months ended June 30, 2024. Net loss for the quarter ended June 30, 2025, was $21.2 million compared to $1.2 million for the quarter ended June 30, 2024. The net loss increase was a result of the Company’s sale of its New Jersey accumulated net operating losses in the second quarter of 2024, with a corresponding $16.2 million income tax benefit. Research and development (R&D) expenses were $18.4 million for the quarter ended June 30, 2025, compared to $14.6 million for the quarter ended June 30, 2024. The increase in R&D expenses was primarily due to increased contractual research organization costs for the advancement of the rezatapopt program. General and administrative (G&A) expenses were $4.5 million...

Enrollment on track in Phase 2 pivotal portion of PYNNACLE clinical trial evaluating rezatapopt as monotherapy in patients with TP53 Y220C and KRAS wild-type advanced solid tumors Interim analysis from Phase 2 PYNNACLE trial expected mid-2025; PMV plans to provide interim analysis data for approximately 50 patients with at least 18 weeks of follow-up Cash, cash equivalents, and marketable securities of $165.8 million as of March 31, 2025, providing expected cash runway to end of 2026 PRINCETON, N.J., May 09, 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 reported financial results for the first quarter ended March 31, 2025, and provided a corporate update. PMV Pharma plans to provide interim analysis data from the Phase 2 PYNNACLE trial in the middle of 2025. This interim analysis will include data for approximately 50 patients, of which approximately 40% are in the ovarian cancer cohort, who have been followed for at least 18 weeks. “Our registrational PYNNACLE trial continues to progress well and enrollment remains on track,” said David Mack, Ph.D., President and Chief Executive Officer of PMV Pharma. “I am very appreciative of the efforts of our team and their continued execution. We look forward to providing data from the interim analysis in the middle of this year.” Corporate Highlights Paper published in Cancer Discovery describing the discovery of rezatapopt. The paper entitled, “Restoration of the Tumor Suppressor Function of Y220C-Mutant p53 by Rezatapopt, a Small Molecule Reactivator,” can be accessed here. First Quarter 2025 Financial Results PMV Pharma ended the first quarter with $165.8 million in cash, cash equivalents, and marketable securities, compared to $183.3 million as of December 31, 2024. Net cash used in operations was $18.3 million for the three months ended March 31, 2025, compared to $16.2 million for the three months ended March 31, 2024. Net loss for the quarter ended March 31, 2025, was $17.5 million compared to $15.3 million for the quarter ended March 31, 2024. Research and development (R&D) expenses were $17.4 million for the quarter ended March 31, 2025, compared to $13.2 million for the quarter ended March 31, 2024. The increase in R&D expen...