Vepdegestrant

– This submission is supported by the pivotal Phase 3 VERITAC-2 clinical trial, results of which were recently presented at the 2025 American Society for Clinical Oncology Annual Meeting and published in The New England Journal of Medicine – – VERITAC-2 data support vepdegestrant as a potential treatment option in patients with ESR1m ER+/HER2- advanced or metastatic breast cancer – NEW HAVEN, CT, USA I June 06, 2025 I Arvinas, Inc. (Nasdaq: ARVN), today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) with its partner Pfizer Inc. (NYSE: PFE), for vepdegestrant for the treatment of patients with ER-positive (ER+)/human epidermal growth factor receptor 2 (HER2)-negative (ER+/HER2-) ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. This submission is based on results from VERITAC-2 (NCT05654623), a global, randomized Phase 3 trial evaluating vepdegestrant versus fulvestrant. “This milestone comes after an exciting presentation at the American Society of Clinical Oncology’s annual meeting,” said John Houston, Ph.D., Chairperson, Chief Executive Officer and President at Arvinas. “We look forward to the NDA review and to the first ever FDA-approved PROTAC ER degrader potentially being available to patients who could benefit from a much needed, new treatment option.” Vepdegestrant is being jointly developed by Arvinas and Pfizer for the treatment of patients with advanced or metastatic ER+/HER2- breast cancer and was granted fast track designation as a monotherapy by the FDA . Results from the VERITAC-2 study were recently presented in a late-breaking oral presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting and were selected for the ASCO press briefing and for Best of ASCO. Detailed results were also simultaneously published in the New England Journal of Medicine . About the VERITAC-2 Clinical Trial The Phase 3 VERITAC-2 clinical trial ( NCT05654623 ) is a global, randomized trial evaluating the efficacy and safety of vepdegestrant (ARV-471) as a monotherapy compared to fulvestrant in patients with ER+/HER2- advanced or metastatic breast cancer. The trial enrolled 624 patients at sites in 25 countries who had previously received treatment with a CDK4/6 inhibitor plus endocrine therapy. Patients were randomized 1:1 to receive either vepdegestrant once daily, orally on a 28-day continuous dosing schedule, or fulvestrant, administered intramuscularly on Days 1 and 15 of Cycle 1 and then on Day 1 of each 28-day cycle starting from Day 1 of Cycle 2. In the trial, 43% of patients (n=270) had ESR1 mutations detected. The primary endpoint was progression-free survival (PFS) in the ESR1-mutation and intent-to-treat populations as determined by blinded independent central review. Overall survival is the key secondary endpoint. About Vepdegestrant Vepdegestrant is an investigational, orally bioavailable PROTAC (PROteolysis TArgeting Chimera) protein degrader designed to specifically target and degrade the estrogen receptor (ER). Vepdegestrant is being developed as a potential monotherapy for ER+/HER2- advanced or metastatic breast cancer with estrogen receptor 1 (ESR1) mutations in the second line-plus setting. In July 2021, Arvinas announced a global collaboration with Pfizer for the co-development and co-commercialization of vepdegestrant; Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits. The U.S. Food and Drug Administration (FDA) has granted vepdegestrant Fast Track designation as a monotherapy in the treatment of adults with ER+/HER2- advanced or metastatic breast cancer previously treated with endocrine-based therapy. About Arvinas Arvinas (Nasdaq: ARVN) is a clinical-stage biotechnology company dedicated to improving the lives of patients suffering from debilitating and life-threatening diseases. Through its PROTAC (PROteolysis TArgeting Chimera) protein degrader platform, the Company is pioneering the development of protein degradation therapies designed to harness the body’s natural protein disposal system to selectively and efficiently degrade and remove disease-causing proteins. Arvinas is currently progressing multiple investigational drugs through clinical development programs, including vepdegestrant, targeting the estrogen receptor for patients with locally advanced or metastatic ER+/HER2- breast cancer; ARV-393, targeting BCL6 for relapsed/refractory non-Hodgkin Lymphoma; and ARV-102, targeting LRRK2 for neurodegenerative disorders. Arvinas is headquartered in New Haven, Connecticut. For more information about Arvinas, visit www.arvinas.com and connect on LinkedIn and X . SOURCE: Arvinas

Today, a brief rundown of news involving Otsuka Pharmaceutical and Arvinas, as well as updates from Regenxbio, Vigil Neuroscience and Sagimet Biosciences that you may have missed.Vera Therapeutics lost nearly a third of its market value Friday after Otsuka Pharmaceutical presented late-stage study data on a rival drug its developing for the kidney disease IgA nephropathy. At a medical meeting, Otsuka said its therapy, sibeprenlimab, led to a 51% reduction in proteinuria, a key marker of kidney health, after nine months of treatment. Though cross-trial comparisons can be misleading, Veras therapy led to a 42% reduction in proteinuria compared to placebo at a similar timepoint in its own Phase 3 study, causing investors to sell off company shares. Still, some analysts defended Vera. Jefferies Farzin Haque cautioned not to overinterpret the data and argued the two datasets are not clinically or statistically different for commercial uptake. The Food and Drug Administration could approve Otsukas drug by Nov. 28. On Monday, Vera said it intends to file an accelerated approval application in the fourth quarter. Ben FidlerArvinas and partner Pfizer have filed for a U.S. approval of their experimental protein-degrading drug for breast cancer, Arvinas said Friday. The two submitted the therapy,vepdegestrant, for use in people with estrogen-receptor positive, HER2 negative breast cancer and a mutation in the ESR1 gene. The application is based on Phase 3 datapresented at the American Society of Clinical Oncology meeting this week showing the drug held tumors in check longer than a standard treatment.That benefit was modest, however, and wasnt observed in the overall study population. Delilah AlvaradoRegenxbio released new data Thursday showing a potential impact on muscle function among Duchenne muscular dystrophy patients who received its experimental gene therapy in an early-stage clinical trial. Regenxbio said those given the dose its using in pivotal testing outperformed how historical data suggests they might on multiple widely used assessments of functional benefits. Still, shares fell by double digits, as some key information was missing from the update, the treatments effects appear to be plateauing and there is concern the data may not be strong enough to support an accelerated approval, wrote Jefferies analyst Maury Raycroft. Regenxbio expects to report pivotal data next year and has said it intends to seek a speedy approval afterwards, based on the therapys ability to produce a tiny version of a muscle-protecting protein. Ben FidlerVigil Neuroscience reported Wednesday the failure of a mid-stage trial meant to prove its most advanced drug works as intended. The study enrolled 20 people with ALSP, a rare disorder hallmarked by the erosion of white matter in the brain. All participants received Vigils drug, VGL101, which is designed to boost the TREM2 proteins that help control inflammation in the brain. The company said that while showing favorable safety and tolerability, its treatment had no beneficial effects on important markers of effectiveness or biological activity. As such, a separate, so-called long-term extension study is being discontinued. Sanofi is in the process of acquiring Vigil for access to a different TREM2-targeting medicine. Per terms of that deal, rights to VGL101 will be returned to its original licensor, Amgen. Jacob BellShares of Sagimet Biosciences have climbed nearly 40% since partner Ascletis Bioscience on Wednesday reported the companys drug denifanstat succeeded in a Phase 3 trial in China in people with moderate-to-severe acne. The drug produced compelling efficacy in the trial with only mild-to-moderate side effects, which could have positive implications for its ability to treat metabolic dysfunction-associated steatohepatitis, Leerink Partners analyst Thomas Smith wrote in a research note. A 2019 partnership handed Ascletis rights in greater China to denifanstat. Sagimet could receive up to $122 million in future payments, as well as sales royalties, if the drug is approved. Ben Fidler '