Welcome to our dedicated page for PMV Pharmaceuticals news (Ticker: PMVP), a resource for investors and traders seeking the latest updates and insights on PMV Pharmaceuticals stock.
PMV Pharmaceuticals, Inc. (Nasdaq: PMVP) is a pioneering precision oncology company headquartered in Cranbury, New Jersey. Established in 2013 and formerly known as PJ Pharmaceuticals, Inc., PMV Pharmaceuticals focuses on the discovery and development of small molecule therapies specifically targeting p53 mutations, which are prevalent in approximately 50% of all human cancers.
The company’s lead product candidate, PC14586, also known as Rezatapopt, is a small molecule designed to correct and restore the function of the p53 protein. This investigational therapy has shown significant promise in addressing the TP53 Y220C mutation, which is found in about 1% of all solid tumors. The U.S. Food and Drug Administration (FDA) has granted Rezatapopt Fast Track designation for treating locally advanced or metastatic solid tumors with a TP53 Y220C mutation.
In addition to PC14586, PMV Pharmaceuticals is developing other product candidates aimed at different p53 hotspot mutations, including the p53 R273H mutation. The company is actively engaged in the PYNNACLE Phase 2 clinical trial, a registrational, tumor-agnostic trial designed to evaluate the efficacy of Rezatapopt across various cancer types.
PMV Pharmaceuticals collaborates with leading institutions like Foundation Medicine to leverage comprehensive genomic profiling for better targeting and treatment of cancer patients. Foundation Medicine’s FDA-approved tests, such as FoundationOne CDx, play a crucial role in identifying patients who may benefit from PMV Pharma’s therapies.
Financially, PMV Pharmaceuticals has reported significant milestones, including the initiation of global trials and advancements in their therapeutic pipeline. The company remains committed to transforming cancer treatment through innovative oncology solutions.
Latest News:
- Third Quarter 2023 and Recent Corporate Highlights: Media Contact: Kathy Vincent, Greig Communications (kathy@greigcommunications.com)
- PRINCETON, N.J., May 09, 2024 - PMV Pharmaceuticals reports Q1 2024 financial results and provides a corporate update.
- PMV Pharma collaborates with Foundation Medicine to develop Rezatapopt, aiming to offer new therapeutic options for high unmet medical needs.
PMV Pharmaceuticals reported Q3 2024 financial results and provided updates on its PYNNACLE clinical trial. The Phase 2 portion evaluating rezatapopt as monotherapy is progressing with over 75% of sites activated globally. The company ended Q3 with $197.9 million in cash, providing runway through 2026. Net loss increased to $19.2 million from $16.6 million year-over-year. R&D expenses rose to $16.9 million, while G&A expenses decreased to $4.9 million. The company plans an interim analysis by mid-2025 and anticipates a New Drug Application filing by end of 2026.
PMV Pharmaceuticals provided updates on its PYNNACLE clinical trial for rezatapopt. The Phase 2 monotherapy portion is progressing well, with >75% of sites activated globally and interim analysis expected by mid-2025. However, the company is discontinuing the Phase 1b combination arm with KEYTRUDA due to dose-limiting toxicities and clinical benefit. The maximum tolerated dose was established at rezatapopt 500mg daily with pembrolizumab 200mg every three weeks.
Additionally, PMV announced collaboration with MD Anderson and Memorial Sloan Kettering for a new Phase 1b study evaluating rezatapopt in AML/MDS patients with TP53 Y220C mutation, starting Q1 2025.
PMV Pharmaceuticals (Nasdaq: PMVP) reported Q2 2024 financial results and provided an update on the PYNNACLE clinical trial. Key points include:
1. Enrollment is on track for the Phase 2 monotherapy portion of PYNNACLE, with over 60% of sites activated across the U.S., Europe, and Asia-Pacific.
2. The company expects an interim analysis from Phase 2 monotherapy by mid-2025 and anticipates an NDA filing by the end of 2026.
3. Cash position of $212.9 million as of June 30, 2024, providing an expected runway to the end of 2026.
4. Net loss for Q2 2024 was $1.2 million, significantly reduced from $17.4 million in Q2 2023 due to the sale of New Jersey accumulated net operating losses.
5. R&D expenses increased to $14.6 million in Q2 2024, while G&A expenses decreased to $5.5 million.
PMV Pharmaceuticals (Nasdaq: PMVP), a precision oncology company, announced participation in two major investor conferences in June 2024. David H. Mack, Ph.D., CEO, and Deepika Jalota, Pharm. D., Chief Development Officer, will represent PMV at the Jefferies Global Healthcare Conference on June 6 and the Goldman Sachs 45th Annual Global Healthcare Conference on June 12. Both sessions will include a fireside chat format. Live audio webcasts and archived replays will be accessible online at the company's Events & Presentations page.
Foundation Medicine and PMV Pharmaceuticals have partnered to develop FoundationOne®CDx, a genomic profiling test, as a companion diagnostic for PMV Pharma’s investigational therapy, rezatapopt. Rezatapopt targets the TP53 Y220C mutation found in about 1% of solid tumors, often deemed undruggable despite its prevalence in 50% of cancers. This collaboration utilizes Foundation Medicine's real-world data and genomic tests to support PMV Pharma's clinical trials. Rezatapopt received Fast Track designation from the FDA and is undergoing Phase 2 trials.
PMV Pharmaceuticals, Inc. (Nasdaq: PMVP) reported financial results and corporate highlights for Q1 2024. The company dosed the first patient in the Phase 2 PYNNACLE trial for rezatapopt, a potential treatment for advanced solid tumors. Phase 1 data for rezatapopt in advanced ovarian cancer was presented at the 2024 SGO Annual Meeting. The company ended Q1 with $213.1 million in cash, providing expected cash runway to end of 2026.
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