IDEAYA advances darovasertib in uveal melanoma trial

SOUTH SAN FRANCISCO, Calif. - IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a precision medicine oncology company with a market capitalization of $1.47 billion, has announced the progression of its Phase 3 clinical trial for darovasertib as a neoadjuvant therapy for primary uveal melanoma (UM), following a successful FDA Type D meeting. According to InvestingPro data, the company’s stock has shown strong momentum with a 10.63% return over the past week, and current analysis suggests the stock is trading near its Fair Value. The trial aims to evaluate the drug’s safety and efficacy, with a focus on eye preservation and visual acuity maintenance as primary endpoints.

The Phase 3 trial will involve approximately 520 patients, divided into two cohorts with a 2:1 randomization favoring the treatment arm. The first cohort, consisting of 120 patients eligible for enucleation, will be randomized to receive darovasertib or a control. The second cohort, comprising 400 patients eligible for plaque brachytherapy (PB), will be randomized to receive darovasertib followed by PB or PB alone. The company maintains a strong financial position to support this clinical program, with InvestingPro analysis showing more cash than debt on its balance sheet and a healthy current ratio of 14.97x.

The primary clinical endpoint for enucleation patients is the eye preservation rate, which must exceed the lower bound of a 10% eye preservation rate with a 95% confidence interval. For the PB cohort, the primary endpoint is the proportion of patients with a 15-letter loss or more in best corrected visual acuity from the time of randomization to the completion of PB. Secondary endpoints include overall response rate, the proportion of patients with clinically significant macular edema, and the proportion of subjects with a reduction of radiation dose delivered to key eye structures.

Additionally, the trial will measure Event-Free Survival (EFS) as a secondary endpoint for both cohorts, which is required for approval. The company also indicated the potential for earlier submission of the enucleation cohort data for regulatory review, contingent on the maturity of EFS data in both cohorts.

Darovasertib has previously been granted Breakthrough Therapy Designation by the FDA for neoadjuvant therapy in enucleation recommended primary UM and Fast Track designation for its combination with crizotinib in metastatic UM.

IDEAYA Biosciences specializes in precision medicine oncology, focusing on targeted therapeutics for selected patient populations using molecular diagnostics. The company is known for its work in synthetic lethality, an emerging class of precision medicine targets. While currently not profitable, analysts have shown increasing confidence in the company’s prospects, with two analysts recently revising their earnings estimates upward. For deeper insights into IDEAYA’s financial health and growth potential, investors can access comprehensive analysis and 12 additional ProTips through InvestingPro’s detailed research reports.

The information in this article is based on a press release statement from IDEAYA Biosciences.

In other recent news, IDEAYA Biosciences has announced several significant developments. The company reported that Dr. Susan L. Kelley will not seek re-election to the Board of Directors at the 2025 annual meeting. Instead, she will transition to a new role as Chair of the newly formed Clinical Advisory Board. IDEAYA Biosciences also revealed that Joshua Bleharski, Ph.D., has been appointed as the new Chief Financial Officer, effective early May 2025. Dr. Bleharski joins the company after a long tenure at J.P. Morgan, bringing a wealth of experience in both science and finance.

Additionally, analysts at BTIG have reiterated their Buy rating for IDEAYA Biosciences, citing anticipated updates to the company’s pipeline in 2025. These updates include clinical and safety data from the Phase 2 neoadjuvant study of darovasertib and other significant studies. IDEAYA is expected to present findings from the IDE397 + Trodelvy study in MTAP deleted Urothelial Cancer and Phase 1 data for Werner Helicase inhibitor IDE275. These developments are closely watched as they could impact the company’s strategic direction and valuation.

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