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8-K2026-05-12· qwen-plus

ARVN · Arvinas, Inc.

0001628280-26-033875

SEC filing

Summary

Arvinas announced FDA approval of VEPPANU™ (vepdegestrant), the first-ever approved PROTAC therapy, for ESR1m, ER+/HER2- advanced breast cancer; reported Q1 2026 revenue of $15.6M and R&D expenses of $60.3M; and disclosed cash runway into H2 2028.

Key takeaways

Full analysis

This 8-K reports a landmark event for Arvinas: the FDA approval of VEPPANU™ (vepdegestrant), the first PROTAC therapy ever approved, for ESR1-mutated, ER+/HER2- advanced breast cancer. The approval validates over a decade of investment in targeted protein degradation and establishes Arvinas as a platform leader. Concurrently, Arvinas announced the licensing of global rights to VEPPANU to Rigel Pharmaceuticals — a strategic shift that offloads commercial execution risk while preserving royalty upside and enabling capital reallocation toward its broader pipeline. Financially, Q1 2026 reflects this inflection: revenue collapsed to $15.6M from $188.8M YoY due to the completion of Pfizer-funded development milestones under the ARV-471 collaboration, particularly the removal of two Phase 3 trials. R&D spending dropped 33.6% YoY to $60.3M, with $15.2M less spent on vepdegestrant and increased investment in ARV-806 (+$5.6M) and other degraders — signaling active portfolio rebalancing. G&A also declined meaningfully ($7.5M YoY), driven by lower professional fees. Despite the revenue drop, cash remains robust at $614.9M as of March 31, 2026, providing runway into H2 2028 — sufficient to support pivotal data readouts across ARV-102 (PSP trial initiation pending FDA clearance), ARV-806 (dose expansion data in 2026), ARV-393 (DLBCL combination data in H2 2026), and ARV-6723 (first immuno-oncology clinical trial initiation mid-2026). Management commentary underscores confidence in the platform’s differentiation, citing biomarker modulation by ARV-102 not seen with LRRK2 inhibitors and superior TME reprogramming by ARV-6723 versus checkpoint inhibitors or HPK1 inhibitors — positioning Arvinas to compete in high-value neurodegenerative and immuno-oncology markets beyond its first approval.