.September 23, 2024
4:22:00 PM

BTIG analysts reiterated a Buy rating and maintained a $62.00 price target for Ideaya Biosciences (NASDAQ:IDYA) following the company’s latest data update on its co-sponsored trial of darovasertib in neoadjuvant uveal melanoma (UM), along with insights into its Phase 3 strategy. Darovasertib appears to be a breakthrough treatment in the neoadjuvant setting, with data showing it preserves patients’ eyes in up to 61% of cases. A key opinion leader highlighted the potential for universal adoption of the drug upon approval. The agreed-upon Phase 3 plan is seen as favorable, with the potential for full approval by 2028.

The muted stock reaction likely stems from uncertainty around the timeline for approval and the absence of a formal accelerated approval decision from the FDA. However, the analysts see the potential for full approval by 2028, as opposed to mid-to-late 2027 under accelerated approval using ORR as the primary endpoint. Investors are expected to focus on event rates for both study arms moving forward but remain confident in darovasertib’s strong efficacy profile and potential to achieve statistical significance in the Phase 3 trial.