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PMV Pharmaceuticals Reports Third Quarter 2020 Financial Results and Corporate Highlights
U.S. Food and Drug Administration (FDA) clearance of PMV Pharmaceutical’s investigational new drug application for its lead product candidate PC14586PMV
About this update from Pmv Pharmaceuticals, Inc.
[{"type":"text","content":"U.S. Food and Drug Administration (FDA) clearance of PMV Pharmaceutical’s investigational new drug application for its lead product candidate PC14586PMV Pharma lead product candidate PC14586 granted Fast Track designation by the FDA Expanded Board of Directors with appointment of Rich Heyman, Ph.D., and Laurie StelzerSuccessful completion of initial public offering, raising approximately $243.5 million. CRANBURY, N.J., Nov. 13, 2020 (GLOBE NEWSWIRE) -- PMV Pharmaceuticals, Inc. (Nasdaq: PMVP), a precision oncology company pioneering the discovery and development of small molecule, tumor-agnostic therapies targeting p53 mutants, today reported financial results for the third quarter ended September 30, 2020, and provided corporate highlights.\n “PMV Pharma has achieved important scientific, clinical, and operational milestones over the past quarter,” said David Mack, Ph.D., President and Chief Executive Officer. “The Investigational New Drug (IND) application for our lead product candidate PC14586 was cleared by the U.S. FDA in September. We believe the capital raised to date will enable us to execute on the clinical development of PC14586, while also continuing to invest in our discovery pipeline of small molecule, tumor-agnostic precision medicine products.” Corporate Highlights Received IND clearance from the FDA to initiate a Phase 1/2 study of PC14586 in patients with advanced solid tumors that have a p53 Y220C mutation. The Phase 1/2 study will enroll patients with a p53 Y220C mutation as determined by next generation sequencing. Phase 1 will evaluate escalating doses of PC14586 to determine the recommended Phase 2 dose and to assess safety, pharmacokinetics, and preliminary anti-tumor activity. Phase 2 will determine the overall response rate and duration of response. For more information, please visit www.clinicaltrials.gov (NCT study identifier NCT04585750).In October, the U.S. FDA granted PMV Pharma Fast Track designation to PC14586 for the treatment of patients with locally advanced or metastatic solid tumors that have a p53 Y220C mutation.Expanded PMV Pharma’s management team and Board of Directors by adding Robert Ticktin as General Counsel, along with Rich Heyman, Ph.D. as Chair of the Board of Directors, and Laurie Stelzer, as Audit Chair of the Board of Directors.Advanced its R273H program, targeting a second p53 ...