Arvinas's PROTAC Drug Approval Ushers in New Era of Medicine

NEW HAVEN, Conn. – May 12, 2026 – Arvinas, Inc. has achieved a landmark victory for a novel class of therapeutics with the U.S. Food and Drug Administration's approval of VEPPANU™ (vepdegestrant), the first-ever PROTAC® protein degrader therapy. The approval, announced today alongside the company's first-quarter financial results, validates a new approach to medicine and positions Arvinas to accelerate a diverse pipeline targeting some of medicine’s most challenging diseases.

VEPPANU is now approved for adults with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-), ESR1-mutated advanced or metastatic breast cancer that has progressed after at least one line of endocrine therapy. This specific mutation is a common driver of treatment resistance, representing a significant unmet need for thousands of patients.

In a strategic move to focus on its research and development engine, Arvinas and its partner Pfizer have entered into an exclusive global licensing agreement with Rigel Pharmaceuticals, Inc. for the commercialization of VEPPANU. This deal not only places the drug in the hands of a company with an established oncology commercial team but also provides Arvinas with significant non-dilutive capital to fuel its next wave of innovation.

“The approval of VEPPANU is a defining achievement for Arvinas and reflects the culmination of more than a decade of focused work to translate our PROTAC science into our first approved therapy,” said Randy Teel, Ph.D., who was recently appointed President and Chief Executive Officer at Arvinas. “I’m proud to lead an organization advancing an industry-leading portfolio of degraders - one that has now joined the short list of those able to bring a new therapeutic modality from discovery to approval.”

A Strategic Deal to Fuel the Pipeline

Under the terms of the agreement, Rigel will take over the global development, manufacturing, and commercialization of VEPPANU. Arvinas and Pfizer will receive an upfront payment and are eligible for substantial future milestone payments and tiered royalties on global net sales. This structure allows Arvinas to reap the financial rewards of its discovery while dedicating its internal resources to advancing its broad clinical pipeline.

Rigel Pharmaceuticals, with its existing commercial infrastructure targeting hematologists and oncologists, is well-equipped to launch VEPPANU in a competitive U.S. market. The oral drug will compete with other therapies, including another oral SERD, but its novel mechanism and clinical data provide a strong foundation. In its pivotal trial, VEPPANU demonstrated a clinically meaningful improvement in progression-free survival for patients with the ESR1 mutation, a difficult-to-treat population.

This licensing strategy is a calculated decision, allowing Arvinas to avoid the immense cost and complexity of building a commercial sales force from scratch. Instead, the company can maintain its focus as a pioneer in drug discovery and development, leveraging the VEPPANU success story to power its future.

The PROTAC Revolution Has Begun

The approval of VEPPANU is more than a single product milestone; it is a watershed moment for the entire field of targeted protein degradation (TPD). Unlike traditional drugs that merely inhibit the function of a problematic protein, PROTACs (PROteolysis TArgeting Chimeras) are designed to eliminate them entirely.

These innovative molecules act as a bridge, linking a disease-causing protein to the cell's natural protein disposal machinery, known as the ubiquitin-proteasome system. This process tags the target protein for destruction, effectively removing it from the cell. This approach has the potential to address targets previously considered “undruggable” and may offer a more profound and durable response than inhibition alone.

VEPPANU's journey from laboratory concept to FDA-approved medicine de-risks the entire PROTAC platform. It provides a clear regulatory and clinical precedent, which is expected to accelerate investment and development across the industry for other companies working on similar technologies. The validation signals that this new modality can be harnessed safely and effectively, opening up new therapeutic possibilities for a wide range of diseases.

Beyond Breast Cancer: A Deep and Diverse Pipeline

With VEPPANU's commercial future secured, Arvinas is highlighting the depth of its pipeline, which demonstrates the versatility of the PROTAC platform across oncology, neurodegeneration, and rare diseases.

Promising new data was presented for ARV-102, a brain-penetrant LRRK2 degrader for Parkinson’s disease. Phase 1 results showed that the oral drug successfully degraded over 50% of the LRRK2 protein in the cerebrospinal fluid of patients. Critically, this was accompanied by a reduction in neuroinflammatory biomarkers, a level of modulation not previously seen with LRRK2 inhibitors. The company plans to advance ARV-102 into a Phase 1b trial for progressive supranuclear palsy (PSP) later this year.

Arvinas is also making inroads into the highly competitive immuno-oncology space with ARV-6723, an HPK1 degrader. Preclinical data showed the drug could reverse T-cell exhaustion and boost anti-tumor immunity, even in models resistant to current checkpoint inhibitors. A Phase 1 trial in patients with advanced solid tumors is slated to begin in mid-2026.

The company’s pipeline also includes:

• ARV-806: A degrader targeting the notorious KRAS G12D mutation, with dose escalation complete in its Phase 1 trial for solid tumors.
• ARV-393: A BCL6 degrader showing early signs of efficacy in non-Hodgkin’s lymphoma, now being tested in combination with another therapy.
• ARV-027: A degrader for polyQ-AR, the protein that causes the rare neuromuscular disorder Spinal-Bulbar Muscular Atrophy (Kennedy's disease), which has just entered Phase 1 trials.

Financial Strength and Forward Momentum

Financially, Arvinas reported cash, cash equivalents, and marketable securities of $614.9 million as of March 31, 2026. The company stated these funds, bolstered by the anticipated payments from the Rigel deal, are sufficient to fund its operating plan into the second half of 2028. This strong financial runway provides the stability needed to execute on its ambitious clinical development goals across its entire portfolio.

The company’s first-quarter results showed a decrease in revenue and expenses compared to the prior year, primarily due to the timing of collaboration revenue recognition and disciplined cost management. The appointment of Dr. Teel as CEO marks a new chapter for Arvinas, transitioning from a company focused on proving its science to one leveraging a landmark approval to build a multi-product pipeline. This strategic focus, backed by a validated platform and a robust balance sheet, positions Arvinas to continue its pioneering work in the new era of protein degradation.