Arvinas NASDAQ: ARVN said it is concentrating resources on its early-stage oncology and neurology pipeline after reaching several strategic milestones in the first half of 2026, including FDA approval of VEPPANU, the first approved PROTAC degrader, and an out-licensing agreement for the product with Rigel Pharmaceuticals.
President and Chief Executive Officer Randy Teel said Rigel expects to make VEPPANU available to patients “in the very near future.” Arvinas also decided that its KRAS G12D program, ARV-806, will advance only through a partner, citing investment needs that do not align with its current capital-allocation strategy.
“We’ve fully shifted our focus to our phase I clinical programs,” Teel said, highlighting three assets with clinical data catalysts expected over the next 12 months: ARV-393 in lymphoma, ARV-027 in spinal and bulbar muscular atrophy, and ARV-102 in neurodegenerative disease.
ARV-393 lymphoma data expected by year-end
Arvinas remains on track to report initial phase I data for ARV-393, its BCL-6 degrader, by the end of 2026. BCL-6 is a transcription factor involved in B-cell development, and altered activity has been associated with several non-Hodgkin lymphoma subtypes.
Teel said the study initially began at doses below the company’s predicted efficacious exposure range following FDA feedback, contributing to enrollment challenges and longer timelines. Enrollment has accelerated as dosing has approached the expected efficacious range, while enrollment in the combination portion of the study with glofitamab, or glofi, has been strong since it started several months ago.
The company previously observed early responses at low doses in difficult-to-treat T-cell lymphomas, including angioimmunoblastic T-cell lymphoma, as well as in B-cell lymphomas. However, Teel said most data reported in 2026 will come from early cohorts dosed below the anticipated efficacious range. Those early cohorts included a higher-than-expected proportion of T-cell lymphoma patients.
Arvinas plans a further disclosure in 2027 with more mature monotherapy data, including diffuse large B-cell lymphoma, or DLBCL, patients treated with ARV-393 alone and in combination with glofi. Teel said the company sees potential opportunities for the program in later-line monotherapy and, if combination data support it, potentially earlier treatment settings.
ARV-027 advances into multiple-dose study
Arvinas completed single-ascending-dose cohorts in healthy volunteers for ARV-027 and initiated the multiple-dose portion of the phase I trial. ARV-027 targets polyglutamine-expanded androgen receptor, or polyQ-AR, the protein that drives spinal and bulbar muscular atrophy, also known as Kennedy’s disease.
The company estimates that between 10,000 and 13,000 patients have been diagnosed with the rare neuromuscular disorder in major markets, while noting that the condition may be substantially underdiagnosed. Teel said ARV-027 is designed as an oral therapy that could degrade the disease-causing protein in skeletal muscle.
Arvinas intends to report exposure, muscle androgen-receptor degradation and initial safety data from healthy volunteers in the first half of 2027. The company said these measures could provide proof of mechanism for the program. The trial design also includes a multiple-dose cohort in patients with spinal and bulbar muscular atrophy.
Chief Scientific Officer Angela Cacace said the company aims to demonstrate a 50% reduction of polyQ-AR in muscle, based on its preclinical work and other published preclinical studies. Functional changes would be assessed in subsequent registrational-intended studies, including through measures such as the SBMA Functional Rating Scale, she said.
ARV-102 trials now expected to begin in 2027
Arvinas is working with regulators on plans to begin patient trials of ARV-102, its LRRK2 degrader for progressive supranuclear palsy, or PSP, and Parkinson’s disease. The company completed a phase I trial in the Netherlands earlier this year and submitted an investigational new drug application to the FDA to support a U.S. phase Ib study.
Teel said the FDA requested additional information and final chronic toxicology data before authorizing the U.S. study. Those toxicology studies have now been completed, but ongoing discussions with U.S., European and Japanese health authorities have pushed the anticipated start of next trials into 2027.
The company expects to present additional phase I biomarker data, including oculomotor measures and cerebrospinal-fluid proteomics, at the MDS conference in October. In discussing future PSP studies, Teel said Arvinas is considering a two-part approach involving a phase Ib trial and a registrational-oriented study that could involve treatment periods of six months or a year. Cacace said the company expects to focus initially on Richardson syndrome, the largest PSP subtype, without further restricting the population.
Management said ARV-102’s degradation approach could address multiple aspects of LRRK2 biology, including kinase, GTPase and scaffolding functions. The company said it believes this may differentiate the program from LRRK2 inhibitors.
Additional pipeline and financial updates
Arvinas also said it remains on track to begin enrollment in a phase I study of ARV-6723, an oral HPK1 degrader and its first immuno-oncology PROTAC, in the coming weeks. Cacace said preclinical studies showed antitumor activity across multiple models, including checkpoint-resistant tumors. Teel said the early clinical program is expected to include monotherapy dose escalation and a combination component, with PD-1 therapy viewed as the likely initial combination partner.
The company also highlighted preclinical work on an oral pan-KRAS degrader, which it said showed activity across a range of KRAS mutations and KRAS amplification. Arvinas plans to present additional combination data at an upcoming scientific conference.
For the second quarter, Chief Financial Officer Andrew Saik reported $567.9 million in cash equivalents and marketable securities as of June 30, down from $685.4 million at the end of 2025. The company maintained guidance that its cash runway extends into the second half of 2028.
- Total revenue was $249.7 million for the quarter.
- Arvinas recorded $62.5 million in license revenue from the Rigel agreement, with $35 million received during the quarter.
- The company recorded a $50 million milestone payment from Pfizer triggered by VEPPANU’s FDA approval.
- Research and development expense was $52.6 million, compared with $68.6 million in the prior-year period.
- General and administrative expense was $24 million, compared with $25.3 million a year earlier.
Saik said Arvinas recognized all remaining deferred revenue from its original Pfizer collaboration during the quarter and expects no further revenue recognition from that agreement. The company also recorded a $52.7 million liability for estimated remaining VEPPANU development closeout costs.
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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