USFDAMay 12, 2026, 07:07 AM
Arvinas' VEPPANU Gets First FDA PROTAC Approval; Licensed to Rigel
AI Summary
Arvinas announced the landmark FDA approval of VEPPANU (vepdegestrant), the first-ever PROTAC therapy, for ESR1-mutated, ER+/HER2- advanced breast cancer, and subsequently licensed its exclusive global rights to Rigel Pharmaceuticals. The company reported a Q1 2026 net loss of $(57.6) million on revenue of $15.6 million, with the revenue decrease primarily due to changes in collaboration cost estimates. Arvinas also provided positive updates on its pipeline, including promising Phase 1 data for ARV-102 in Parkinson's disease and the initiation of new clinical trials, while maintaining a strong cash position expected to fund operations into 2H 2028.
Key Highlights
- FDA approved VEPPANU (vepdegestrant), the first PROTAC therapy, for ESR1m, ER+/HER2- advanced breast cancer.
- Exclusive global development, manufacturing, and commercialization rights for VEPPANU licensed to Rigel Pharmaceuticals.
- Q1 2026 revenue was $15.6 million, a decrease from $188.8 million in Q1 2025.
- Q1 2026 net loss was $(57.6) million, compared to net income of $82.9 million in Q1 2025.
- Cash, cash equivalents, and marketable securities totaled $614.9 million as of March 31, 2026.
- Company's cash runway is sufficient to fund operations into the second half of 2028.
- ARV-102 Phase 1 data showed >50% LRRK2 degradation in CSF of Parkinson's disease patients.
- Randy Teel, Ph.D., was appointed President, Chief Executive, and Director.
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