Arvinas NASDAQ: ARVN said its first quarter was marked by the FDA approval of VEPPANU, a new licensing agreement with Rigel Pharmaceuticals and continued progress across a clinical-stage pipeline focused on targeted protein degradation.
President and Chief Executive Officer Randy Teel said the approval of VEPPANU for ESR1-mutant, ER-positive, HER2-negative advanced breast cancer represents “the first ever approval of the heterobifunctional PROTAC degrader” and validates the company’s targeted protein degradation platform. Teel said Arvinas and Pfizer have entered into a global licensing agreement with Rigel Pharmaceuticals for the commercialization, development and manufacturing of VEPPANU.
Teel said Rigel has an established oncology sales team and infrastructure to make VEPPANU available to patients. He said the agreement allows Arvinas to focus capital on its next generation of degraders across oncology, neurodegenerative disorders and neuromuscular diseases.
VEPPANU Licensing Deal Shifts Commercial Role to Rigel
During the question-and-answer portion of the call, Chief Financial Officer Andrew Saik said Arvinas and Pfizer each have a 50% interest in the out-licensing arrangement, meaning milestones and royalties will be split equally between the two companies. Saik said the economics discussed in the company’s press release largely relate to the U.S., where VEPPANU is currently approved, and that Rigel holds global rights.
Saik said Rigel is primarily focused in the U.S. and would need partners to launch internationally. He added that any international royalty back to Arvinas and Pfizer was not disclosed because the product currently has U.S. approval only.
Teel said ongoing VEPPANU trials are being run by Arvinas and Pfizer, with Rigel providing some cost offsets for ongoing development plans. Future development economics would fall to Rigel after the transaction closes, he said.
ARV-102 Data Support PSP Strategy, but U.S. Trial Faces FDA Hold
Chief Medical Officer Noah Berkowitz highlighted recently presented Phase 1 data for ARV-102, an oral PROTAC designed to cross the blood-brain barrier and degrade LRRK2. Berkowitz said Phase 1 data in Parkinson’s disease patients showed approximately 50% or greater reductions in cerebrospinal fluid LRRK2 by day 14 across dose levels, sustained through day 28. He said ARV-102 also produced dose-dependent reductions in biomarkers of neuroinflammation and lysosomal stress, including CD68 and GPNMB, and was generally well tolerated with no serious adverse events through 28 days of dosing.
Arvinas is focusing ARV-102 initially on progressive supranuclear palsy, or PSP, a rapidly progressive tauopathy with no disease-modifying therapies. Berkowitz said PSP affects about 25,000 patients in the U.S. and that elevated LRRK2 expression is associated with faster progression.
The company disclosed that its planned U.S. Phase 1b trial in PSP is on clinical hold. Berkowitz said the FDA requested final data from chronic toxicology studies in non-human primates before authorizing the trial. Arvinas expects those data in mid-2026 and anticipates the U.S. trial could begin by the end of 2026. Berkowitz said the request is not expected to affect European trial plans or the company’s guidance for the start of a global Phase 2 study.
Oncology Pipeline Updates Focus on KRAS and BCL6
Berkowitz said Arvinas completed enrollment of the dose-escalation portion for once-weekly ARV-806, its KRAS G12D degrader, ahead of schedule. He said the company expects initial data later this year, including safety, pharmacokinetic, pharmacodynamic and early response data.
ARV-806 is designed to degrade both active and inactive forms of KRAS G12D. Berkowitz said preclinical data showed roughly 25- to 40-fold greater potency than clinical-stage KRAS G12D inhibitors and degraders, with more than 90% degradation lasting seven days after a single dose in preclinical testing.
In response to analyst questions, Berkowitz said Arvinas is planning dose expansion to evaluate two doses, with dose selection to consider response, degradation data and safety. He said pancreatic cancer makes practical sense for expansion because it is a monotherapy setting with accessible patients and high unmet need.
Arvinas also continues to advance ARV-393, its BCL6 degrader, in a Phase 1 monotherapy dose-escalation trial in relapsed or refractory B-cell and T-cell lymphomas. Berkowitz said the company has seen early responses in both populations, including at exposure levels below those predicted to be efficacious. The company has also initiated a combination trial with glofitamab in diffuse large B-cell lymphoma.
Neuromuscular and Discovery Programs Advance
Chief Scientific Officer Angela Cacace discussed ARV-027, an oral PROTAC degrader being developed for spinal and bulbar muscular atrophy, also known as SBMA or Kennedy’s disease. She said the therapy is designed to eliminate toxic polyglutamine-expanded androgen receptor protein from muscle cells. Arvinas has enrolled the first three cohorts in a Phase 1 single-ascending-dose study in healthy volunteers.
Cacace said preclinical data in an aggressive SBMA mouse model showed ARV-027 degraded the toxic androgen receptor in muscle, improved functional measures and extended survival. Teel later said ARV-027 differs from prior Arvinas androgen receptor degraders because it was selected for activity in muscle.
Cacace also reviewed ARV-6723, an oral immuno-oncology PROTAC targeting HPK1. She said the program is on track to enter the clinic later this year. In preclinical models, she said ARV-6723 showed single-agent antitumor activity, including in checkpoint-resistant models, and affected the myeloid compartment of the tumor microenvironment.
The company also continues preclinical work on an oral pan-KRAS PROTAC program. Cacace said Arvinas has observed broad KRAS degradation across multiple alterations, including wild-type amplified KRAS, with selectivity over other RAS isoforms.
First-Quarter Revenue Falls as Expenses Decline
Saik said Arvinas ended the first quarter with $614.9 million in cash, cash equivalents and marketable securities, down from $685.4 million at the end of 2025. He said the company continues to expect its cash runway to extend into the second half of 2028.
First-quarter revenue totaled $15.6 million, compared with $188.8 million in the same period of 2025. Saik said the $173.2 million decrease was due to lower revenue recognized from the vepdegestrant collaboration with Pfizer, driven by changes to estimated remaining program costs.
General and administrative expenses fell to $19.1 million from $26.6 million a year earlier, primarily due to lower professional fees. Research and development expenses declined to $60.3 million from $90.8 million, driven by lower compensation-related expenses and lower program-specific spending. Saik said cost reduction programs initiated last year and expected to finish in mid-2026 continue to reduce expenses.
Teel said Arvinas is positioned for multiple clinical updates in 2026, including data from ARV-806 and ARV-393, and expects to move ARV-6723 into the clinic in the coming months.
About Arvinas NASDAQ: ARVN
Arvinas, Inc NASDAQ: ARVN is a biopharmaceutical company focused on the development of therapies based on targeted protein degradation. Utilizing its proprietary proteolysis-targeting chimera (PROTAC®) platform, Arvinas aims to selectively eliminate disease-causing proteins rather than merely inhibit their activity. This novel approach has the potential to address a range of diseases, including oncology, neurodegeneration and inflammation, by harnessing the body's natural protein-recycling systems.
The company's most advanced clinical candidates address hormone-driven cancers.
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