IDEAYA Biosciences’ Trial Expansion and Regulatory Uncertainties Lead to Hold Rating

Andrew Berens, an analyst from Leerink Partners, maintained the Hold rating on IDEAYA Biosciences (IDYA – Research Report). The associated price target remains the same with $27.00.

Andrew Berens has given his Hold rating due to a combination of factors surrounding the recent updates to IDEAYA Biosciences’ Phase 3 trial design for darovasertib. The trial, which targets primary uveal melanoma, has seen an increase in the sample size to approximately 520 patients, a 30% rise from previous plans. This expansion, while potentially extending timelines, is aimed at ensuring robust data collection by including a broader patient cohort.
Moreover, the absence of a requirement for event-free survival (EFS) detriment prior to approval suggests a lower likelihood of accelerated approval, which could impact the stock’s near-term potential. Despite this, the company remains optimistic about the possibility of earlier approval for the enucleation cohort. These trial design changes, while strategic, introduce uncertainties regarding timelines and regulatory outcomes, contributing to the Hold rating.