Catalyst overview
Research summary
This catalyst tracks a Phase 2 data readout for Darovasertib in Uveal melanoma. The expected timing is based on the latest available company guidance and may change.
OptimUM-10 Ph3 trial. 9/23/24- Interim data & successful FDA Type C meeting. 3/31/25- Received FDA BTD. 9/8/25- Announced interim Ph2 data. 11/04/25:- Positive data reported; initiated Ph3 trial; Servier ex-US licensing finalized. 02/17/26:- Enrollment ongoing; full enrollment of ~450 patients targeted by H1 2027. 05/05/26:- Targeting OptimUM-09 Ph2 data update H2 2026; OptimUM-10 Ph3 full enrollment now expected YE 2027. 07/17/26:- OptimUM-09 Ph2 follow-up data to be presented at ESMO Oct 23-27, 2026. 08/04/26:- OptimUM-09 ESMO data planned October 2026; OptimUM-10 capital allocation under review.
Verification
Confirm timing and program details against the company announcement or filing.