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0.000902527075812309 0 -0.00150421179302037 -0.00541516245487364 -0.0120336943441636 -0.00722021660649825 -0.0246690734055355 -0.0345968712394705
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IDEAYA Biosciences Receives US FDA Breakthrough Therapy Designation for Darovasertib Monotherapy in Neoadjuvant 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
BTD application was supported by updated clinical data from Ph2 neoadjuvant UM trial that we are targeting to present at medical conferences in mid-2025 and H2 2025 Targeting to initiate a Ph3 registrational study in neoadjuvant UM in H1 2025 Neoadjuvant UM has a projected annual incidence of ~12k patients, and is a high unmet medical with no FDA approved systemic therapies SOUTH SAN FRANCISCO, Calif. March 31, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for the neoadjuvant treatment of adult patients with primary uveal melanoma (UM) for whom enucleation has been recommended. "We are pleased to receive FDA Breakthrough Therapy designation as we prepare to advanc Show less Read more
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