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IDEAYA Biosciences Announces Successful FDA Type D Meeting on Phase 3 Registrational Trial Design for Darovasertib as Neoadjuvant Therapy for Primary Uveal Melanoma [Yahoo! Finance]

IDEAYA Biosciences, Inc. (IDYA) 
Last ideaya biosciences, inc. earnings: 3/24 06:00 am Check Earnings Report
Company Research Source: Yahoo! Finance
Clinical endpoints supportive of full approval based on FDA Type D Meeting: Eye preservation rate as the primary endpoint for enucleation patients. Proportion of patients with best corrected visual acuity 15-letter loss from time of randomization and time of completion of plaque brachytherapy (PB) as the primary endpoint for PB patients. No detriment to Event-Free-Survival (EFS) is required for both cohorts as a secondary endpoint We project registrational trial enrollment for the enucleation cohort will be 120 patients and 400 patients for the plaque brachytherapy cohort with a 2:1 randomization Potential to submit the enucleation cohort data for regulatory review earlier than the PB cohort pending the EFS data maturity in both cohorts SOUTH SAN FRANCISCO, Calif. April 14, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq:IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced a successful FDA Type D meeti Show less Read more
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