Key insights
- IDEAYA Biosciences plans to file an NDA for darovasertib to treat uveal melanoma under FDA fast review. Phase 2/3 trial met its primary endpoint, reducing disease progression risk by 58%. Analysts see the company as undervalued. While positive, the drug is still years from market, and the company's market cap is relatively small, limiting broad market impact.
SOUTH SAN FRANCISCO - IDEAYA Biosciences (NASDAQ:IDYA) announced today that the FDA has agreed to review its New Drug Application for darovasertib in combination with crizotinib for first-line HLAA2-negative metastatic uveal melanoma under the Real-Time Oncology Review program. Shares closed at $28.05, down 8.6% over the past week, giving the company a market capitalization of $2.46 billion.
The company plans to initiate the RTOR submission process with the first pre-submission targeted for May, with completion of the NDA filing expected in the second half of 2026. The RTOR program allows IDEAYA to pre-submit components of its NDA for FDA review before the complete filing is submitted.
On April 13, IDEAYA reported that the Phase 2/3 OptimUM-02 trial met its primary endpoint. The combination reduced the risk of disease progression by 58% with a hazard ratio of 0.42 and achieved a median progression-free survival of 6.9 months versus 3.1 months in the investigator choice of therapy arm.
The trial showed an overall response rate of 37.1%, including five complete responses, in patients treated with the darovasertib combination versus 5.8% in the control arm. The median duration of response was 6.8 months. Overall survival data were not yet mature, though the combination showed an early trend in improvement versus the control arm.According to InvestingPro analysis, IDEAYA appears undervalued at current levels, with analysts setting price targets ranging from $35 to $81. The company reports its next earnings on May 12.
The combination was generally well-tolerated with a manageable safety profile consistent with previously reported results and known side-effects of each drug, according to the press release statement.
Full results from the OptimUM-02 trial will be presented in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology annual meeting in Chicago, Illinois. IDEAYA is also conducting clinical trials of darovasertib in HLAA2-positive metastatic uveal melanoma as well as in neoadjuvant and adjuvant settings of primary uveal melanoma.
In other recent news, IDEAYA Biosciences has announced it will present complete data from its Phase 2/3 OptimUM-02 trial at the American Society of Clinical Oncology Annual Meeting in June. The presentation will focus on the results of darovasertib combined with crizotinib as a first-line treatment for patients with HLA-A2-negative metastatic uveal melanoma. Following the release of positive topline results from this trial, several firms have adjusted their price targets for IDEAYA Biosciences. Guggenheim raised its price target to $54, citing a significant increase in the probability of success for darovasertib. RBC Capital also increased its target to $53, maintaining an Outperform rating. Mizuho followed suit, raising its target to $52 while continuing its Outperform rating, based on the positive trial data. Additionally, Oppenheimer adjusted its price target to $40, noting a substantial reduction in the risk of disease progression with the treatment. These developments reflect the recent advancements and analyst expectations surrounding IDEAYA Biosciences.
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