IDEAYA/SERVIER Eye Cancer Drug Hits Endpoint, Accelerates Approval Path IDEAYA/Servier drug met primary endpoint. Pivotal Phase 2/3 trial succeeded. FDA accelerated approval filing planned. Second half 2026 target. IDEAYA Biosciences and Servier announced their unnamed eye cancer drug achieved its primary endpoint. This occurred in a pivotal Phase 2/3 trial for uveal melanoma. The drug, a targeted protein kinase C (PKC) inhibitor, demonstrated significant efficacy. The specific metric triggering this positive event was not detailed, but it confirms the drug's therapeutic benefit. This positive outcome provides a clear path for regulatory submission. IDEAYA plans to file for accelerated FDA approval in H2 2026. Accelerated approval pathways, outlined in 21 CFR Part 314 Subpart H, allow earlier approval for serious conditions with unmet medical need. The EMA has not yet taken action on this specific drug, but a similar accelerated pathway (Conditional Marketing Authorization) could be pursued. The successful trial de-risks IDEAYA's pipeline and PKC inhibitor platform. This outcome positions IDEAYA and Servier favorably against competitors like Immunocore, which markets Kimmtrak for metastatic uveal melanoma. The planned FDA filing in H2 2026 sets a critical near-term milestone for market entry.