BTIG Reiterates Buy Rating on Ideaya Biosciences (IDYA)
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IDEAYA Biosciences Announces Positive Interim Phase 2 Data for Darovasertib and Successful FDA Type C Meeting on Registrational Trial Design for Regulatory Approval in Neoadjuvant Uveal Melanoma
September 23, 2024 6:00 AM EDTPhase 2 company-sponsored and IST neoadjuvant uveal melanoma (UM) clinical data update in 49 evaluable patients, demonstrates ~49% of patients with >30% tumor shrinkage by product of diameters, and ~61% eye preservation rate for enucleation patientsTargeting to initiate Phase 3 randomized registrational trial in neoadjuvant UM following finalization of the clinical protocol with FDAClinical endpoints supportive of full approval based on FDA guidance: Eye preservation rate as the primary endpoint for enucleation patients. Time to vision loss as the primary endpoint for plaque brachytherapy patients. No detriment to Event-Free-Survival (EFS) in the treatment arms is... More
IDEAYA Announces Webcast to Report Interim Phase 2 Data for Darovasertib and Regulatory Update from FDA Type C Meeting in Neoadjuvant Uveal Melanoma on Monday, September 23, 2024
September 22, 2024 9:00 AM EDTSOUTH SAN FRANCISCO, Calif., Sept. 22, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that the company plans to issue a pre-market press release and conduct an investor webcast on Monday, September 23, 2024, at 8:00 a.m. ET to report interim Phase 2 data for darovasertib and provide a regulatory update from FDA Type C meeting in neoadjuvant uveal melanoma (UM). Darovasertib is... More
