On September 17, 2025 Arvinas, Inc. (Nasdaq: ARVN) reported an update on its collaboration with Pfizer Inc. (NYSE: PFE) for the co-development of vepdegestrant, an investigational oral PROTAC (PROteolysis TArgeting Chimera) estrogen receptor protein degrader, and announced additional corporate actions to support shareholder value creation (Press release, Arvinas, SEP 17, 2025, View Source [SID1234656032]).
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Update on Pfizer Collaboration
Arvinas and Pfizer have jointly agreed to out-license the commercialization rights to vepdegestrant to a third party. Together, the companies have begun seeking a partner with the capabilities and expertise to maximize the commercial potential of vepdegestrant, if approved, for patients with ESR1-mutant, ER+/HER2- advanced or metastatic breast cancer and potentially develop vepdegestrant in new settings. The companies are aligned in their belief that finding a third-party commercial partner is the best path forward to unlock the full value of vepdegestrant and ensure vepdegestrant is available promptly if approved for use by regulatory authorities.
"Today’s announcement further supports our goal to bring vepdegestrant to patients and we are confident that vepdegestrant’s differentiated profile will attract interest from potential partners seeking to strengthen their oncology portfolios," said John Houston, Ph.D., Arvinas Chairperson, Chief Executive Officer and President. "We and Pfizer remain committed to the metastatic breast cancer community and believe vepdegestrant has the potential to be a best-in-class therapeutic option in the second-line ESR1 mutant setting."
Vepdegestrant is currently under review by the U.S. Food and Drug Administration (FDA) as a monotherapy in the treatment of estrogen receptor–positive (ER+), human epidermal growth factor receptor 2–negative (HER2-), ESR1-mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026.
Strategic Plan and Cost Optimization Measures
Following the decision to monetize the value of vepdegestrant and out-license its rights to a third party, Arvinas management and its Board of Directors conducted a thorough review of the Company’s business and strategic plan in consultation with its independent financial and legal advisors. Following this review, the Company continues to believe that its pipeline of differentiated PROTAC degraders has the potential to create important therapies for patients with debilitating and life-threatening diseases across oncology and neuroscience. Arvinas currently has three investigational PROTAC degraders in Phase 1 trials: ARV-102, a LRRK2 degrader for progressive supranuclear palsy and Parkinson’s disease; ARV-393, a BCL6 degrader for subsets of non-Hodgkin lymphoma; and ARV-806, a KRAS G12D degrader for solid tumor malignancies.
With the change to development plan for the vepdegestrant program and a refocus on its early development programs, Arvinas has determined it will take further action to optimize its organizational and cost structures and streamline operations in advance of multiple anticipated value inflection points in the coming months. These actions include:
Further limiting additional expenditures on the vepdegestrant program to support activities required for commercialization readiness and identification and out-licensing of vepdegestrant to a third party for commercialization, subject to alignment with Pfizer;
Reducing the Company’s workforce by an additional 15% to streamline operations, with the most significant reductions being roles related to vepdegestrant commercialization; and
Proactively managing pipeline cost by seeking strategic business development opportunities and by identifying further efficiencies across the business.
These steps build on prior actions by the Arvinas Board and management team to strengthen the Company’s financial profile and drive additional operational efficiencies. The planned out-licensing of vepdegestrant and the resulting cost optimization actions, when combined with the approximately $80 million in annual cost savings from the measures announced on May 1, 2025, are expected to result in overall annual cost savings of more than $100 million compared to FY 2024.
Share Repurchase Program
The Arvinas Board of Directors has authorized the repurchase of up to $100 million of the Company’s common stock. The timing and amount of any share repurchases under the share repurchase program will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of Arvinas’ common stock and general market conditions, and will be at the Company’s discretion. Share repurchases under the share repurchase program may be made from time to time through a variety of methods, which may include open market purchases, privately negotiated block trades, accelerated share repurchases, other privately negotiated transactions or any combination of these methods. Repurchases may also be made under a Rule 10b5-1 plan, which would permit shares to be repurchased when the Company might otherwise be precluded from doing so under insider trading laws. The share repurchase program will be funded using the Company’s working capital. The share repurchase program does not obligate Arvinas to acquire any particular amount of its common stock. The share repurchase program has no time limit and can be modified, suspended or discontinued at any time without prior notice.
The priority of the Arvinas Board of Directors and management is to drive value from the portfolio by deliberately and responsibly deploying capital to advance Arvinas’ programs, which, if successful, will deliver benefits for patients and value for shareholders.
"Arvinas’ decision to repurchase shares is a testament to our conviction in the strength of our business and our long-term growth prospects and demonstrates our commitment to maximizing value for shareholders," said Briggs Morrison, M.D., Arvinas Board Member and Lead Independent Director. "We believe our disciplined management of costs will enable us to continue advancing our PROTAC technology to create transformational therapies for patients with severe diseases, while preserving maximum value creation for shareholders as the Board continues its CEO search."
Cash Runway Guidance
Following the actions announced today, Arvinas is reaffirming its cash runway guidance into the second half of 2028. The Company currently expects that this runway will support multiple opportunities to deliver value from clinical-stage programs derived from the Company’s de-risked and clinically validated platform technology. These opportunities include clinical data readouts from its PROTAC degraders ARV-102, ARV-393, and ARV-806.
About Vepdegestrant
Vepdegestrant is an investigational, orally bioavailable PROteolysis TArgeting Chimera (PROTAC) estrogen receptor degrader. 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; pursuant to the original agreement, Arvinas and Pfizer will share worldwide development costs, commercialization expenses, and profits, including any costs, expenses and profits that arise due to the parties’ agreement to out-license commercialization rights.
Vepdegestrant was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) and has been assigned a Prescription Drug User Fee Act (PDUFA) action date of June 5, 2026.