Arvinas (ARVN) Stock News

Arvinas (NASDAQ:ARVN) and Pfizer announced the FDA's acceptance of the New Drug Application (NDA) for vepdegestrant, a novel treatment for ESR1-mutated, ER+/HER2- advanced breast cancer. The FDA has set a PDUFA date of June 5, 2026.

The application is supported by the pivotal Phase 3 VERITAC-2 trial, which demonstrated significant improvement in progression-free survival compared to fulvestrant. Notably, vepdegestrant is the first PROteolysis TArgeting Chimera (PROTAC) to show clinical benefit in breast cancer patients. The trial results were presented at ASCO 2025 and published in The New England Journal of Medicine.

Arvinas (NASDAQ:ARVN) reported Q2 2025 financial results and significant pipeline developments. The company submitted a New Drug Application for vepdegestrant for ESR1m, ER+/HER2- advanced breast cancer treatment, marking the first-ever PROTAC degrader submission. The Phase 3 VERITAC-2 trial showed a 2.9-month PFS improvement versus fulvestrant in specific patient populations.

Financial highlights include $861.2 million in cash and equivalents as of June 30, 2025, with funding runway into 2H 2028. Q2 revenue was $22.4 million, down from $76.5 million year-over-year, while R&D expenses decreased to $68.6 million from $93.7 million. The company also announced CEO John Houston's planned retirement.

Pipeline progress includes positive ARV-102 Phase 1 data in Parkinson's disease, promising ARV-393 preclinical results, and initiation of the ARV-806 Phase 1 trial for KRAS G12D mutations.

Arvinas (NASDAQ:ARVN), a clinical-stage biotech company focused on targeted protein degradation, has scheduled its Q2 2025 financial results announcement and corporate update for August 6, 2025, at 8:00 a.m. ET. The presentation will be accessible via live webcast in the Events and Presentations section of the company's investor relations website.

A recording of the webcast will be made available on www.arvinas.com after the event concludes.

Arvinas (NASDAQ:ARVN), a clinical-stage biotech company focused on targeted protein degradation, announced that CEO and President John Houston, Ph.D. will retire from his executive roles following the appointment of a successor. Dr. Houston will continue serving as Chairperson of the Board of Directors.

During his 8-year tenure, Houston led Arvinas through significant achievements, including launching six programs into clinical trials, reporting the first positive pivotal Phase 3 trial for a PROTAC degrader, and demonstrating the first oral PROTAC's pharmacodynamic activity in the central nervous system. The Board of Directors has initiated a search for a new CEO to ensure continued leadership.

Arvinas (NASDAQ: ARVN) presented promising preclinical data for ARV-393, their PROTAC BCL6 degrader, at EHA 2025. The drug showed significant single-agent activity in models of lymphoma, particularly in nodal T-follicular helper cell lymphoma (AITL) and transformed follicular lymphoma. When combined with small molecule inhibitors, ARV-393 demonstrated enhanced tumor growth inhibition and tumor regressions in aggressive DLBCL models. Key findings include ≥95% tumor growth inhibition in tFL models and successful combinations with drugs like tazemetostat and venetoclax. RNA sequencing revealed ARV-393's mechanism inhibits tumor cell cycle progression and promotes differentiation. A Phase 1 study is currently enrolling patients with relapsed/refractory non-Hodgkin lymphoma.

Arvinas (NASDAQ: ARVN) and Pfizer have submitted a New Drug Application (NDA) to the FDA for vepdegestrant, targeting ESR1-mutated ER+/HER2- advanced or metastatic breast cancer in patients previously treated with endocrine-based therapy. The submission is backed by the pivotal Phase 3 VERITAC-2 trial results, which were presented at ASCO 2025 and published in The New England Journal of Medicine. If approved, vepdegestrant would become the first FDA-approved PROTAC ER degrader. The drug has already received FDA fast track designation as a monotherapy, highlighting its potential significance in addressing an unmet medical need for patients with this specific type of breast cancer.

Arvinas (NASDAQ: ARVN) will present new preclinical data for ARV-393, their investigational oral PROTAC BCL6 degrader, at the European Hematology Association (EHA) meeting in Milan, Italy from June 12-15, 2025. ARV-393 targets the B-cell lymphoma 6 protein (BCL6), a key driver of B-cell lymphomas. The presentation will showcase preclinical studies of ARV-393 as both a single agent in models of nodal T-follicular helper cell lymphoma, angioimmunoblastic-type (AITL) and transformed follicular lymphoma, and in combination with small molecule inhibitors in diffuse large B-cell lymphoma models. The poster presentation is scheduled for June 13, 2025, from 6:30-7:30 p.m. CEST.

Arvinas and Pfizer announced significant Phase 3 VERITAC-2 trial results for vepdegestrant, their novel PROTAC drug for advanced breast cancer. The drug showed a 2.9-month improvement in median progression-free survival compared to fulvestrant in ESR1-mutant, ER+/HER2- breast cancer patients, reducing disease progression risk by 43%. Vepdegestrant demonstrated strong efficacy with a median PFS of 5.0 months versus 2.1 months for fulvestrant in ESR1-mutant patients. The drug was well-tolerated with low rates of gastrointestinal side effects and few discontinuations. As the first PROTAC evaluated in Phase 3 trials showing benefit in breast cancer patients, Arvinas and Pfizer plan to submit an NDA to the FDA in H2 2025. The trial results were presented at ASCO and published in the New England Journal of Medicine.

Arvinas (NASDAQ: ARVN), a clinical-stage biotech company focused on targeted protein degradation drug development, announced its upcoming participation in the Jefferies Global Healthcare Conference. The company's management will engage in a fireside chat on June 5, 2025, at 2:35 p.m. ET in New York City. Investors and interested parties can access a live audio webcast of the presentation through the company's website under the "Events and Presentations" section of the Investors and Media page.