Arvinas Gains FDA Approval for VEPPANU, Licenses Rights to Rigel
Arvinas reported Q1 2026 results, highlighted by FDA approval of VEPPANU (vepdegestrant) for ESR1m ER+/HER2- advanced breast cancer and a licensing deal with Rigel for exclusive global rights. Pipeline milestones included Phase 1 data for ARV-102 showing >50% LRRK2 degradation in CSF and initiation of ARV-027 dosing in healthy volunteers.
1. Q1 2026 Corporate Update and VEPPANU Approval
During first quarter 2026, Arvinas announced FDA approval of VEPPANU (vepdegestrant) for adults with ESR1-mutated ER+/HER2- advanced or metastatic breast cancer after endocrine therapy. The company also entered an exclusive global licensing agreement with Rigel Pharmaceuticals for VEPPANU’s development, manufacturing and commercialization rights.
2. ARV-102 Phase 1 Clinical Data
Phase 1 trial of ARV-102, an oral LRRK2 degrader for Parkinson’s disease, demonstrated over 50% LRRK2 protein reduction in cerebrospinal fluid by day 14, sustained through day 28, alongside reductions in endolysosomal and neuroinflammatory biomarkers such as CD68 and GPNMB, with no serious adverse events.
3. Progress Across Additional Pipeline Programs
Arvinas completed dose escalation for ARV-806 in KRAS G12D mutant solid tumors, initiated a combination trial of ARV-393 with glofitamab in diffuse large B-cell lymphoma and expanded monotherapy dosing in non-Hodgkin’s lymphoma, while commencing dosing of ARV-027 in a Phase 1 healthy volunteer study and presenting preclinical data for ARV-6723 HPK1 degrader showing robust antitumor activity in immune-resistant solid tumor models.