IDEAYA Biosciences to Initiate New Drug Application Submission from the Darovasertib OptimUM-02 Trial under the Oncology Center of Excellence Real-time Oncology Review (RTOR) Program [TheS...
IDEAYA Biosciences, Inc. (IDYA)
Last ideaya biosciences, inc. earnings: 3/24 06:00 am
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Source: TheStreet.com
SOUTH SAN FRANCISCO, Calif. April 30, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company, today announced that the U.S. Food and Drug Administration (FDA) has agreed to review its New Drug Application (NDA) for darovasertib in combination with crizotinib (darovasertib combination) for patients with first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM) under the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program. "We are grateful for the continued partnership with the FDA and being accepted in the Oncology Center of Excellence Real-Time Oncology Review program based on the topline results from the OptimUM-02 trial. This is an important achievement for IDEAYA and the people living with mUM who today have very few treatment options. We believe the topline results from OptimUM-02 provide further evidence to support the potential benefit of the darovasertib combination in patients with first-line HLA*A2
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News
- IDEAYA Biosciences to Initiate New Drug Application Submission from the Darovasertib OptimUM-02 Trial under the Oncology Center of Excellence Real-time Oncology Review (RTOR) Program [Yahoo! Finance]Yahoo! Finance
- IDEAYA Biosciences to Initiate New Drug Application Submission from the Darovasertib OptimUM-02 Trial under the Oncology Center of Excellence Real-time Oncology Review (RTOR) ProgramPR Newswire
- IDEAYA Biosciences, Inc. (IDYA) PT Increased as Wedbush Highlights Positive OptimUM-02 Trial Readout [Yahoo! Finance]Yahoo! Finance
- IDEAYA Biosciences Announces Late-Breaking Abstract Oral Presentation at ASCO 2026 to Provide Complete Data from Phase 2/3 Registrational Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in 1L HLA*A2-Negative Metastatic Uveal Melanoma [YaYa
- IDEAYA Biosciences Announces Late-Breaking Abstract Oral Presentation at ASCO 2026 to Provide Complete Data from Phase 2/3 Registrational Trial (OptimUM-02) of Darovasertib in Combination with Crizotinib in 1L HLA*A2-Negative Metastatic Uveal Melanoma [ThTh
IDYA
Earnings
- 2/17/26 - Beat
IDYA
Sec Filings
- 4/29/26 - Form DEF
- 4/29/26 - Form ARS
- 4/13/26 - Form 8-K
- IDYA's page on the SEC website