Cantor Fitzgerald has maintained an Overweight rating on Ideaya Biosciences (NASDAQ: IDYA) as the clinical-stage company nears a major data milestone. The reiteration comes ahead of a Phase 2/3 topline progression-free survival - PFS - readout from the OptimUM-02 study expected in late March.
Ideaya shares are trading at $30.77, reflecting a 50.49% increase over the past year. The company carries a market capitalization of $2.71 billion and, according to InvestingPro data cited in company commentary, holds more cash than debt on its balance sheet. InvestingPro assigns Ideaya an overall financial health score of 2.54, labeled as "GOOD," metrics that are notable for a development-stage biotechnology firm approaching a pivotal readout.
Clinical programme and trial design
The OptimUM-02 trial randomizes darovasertib, a protein kinase C - PKC - inhibitor, in combination with crizotinib, a cMET inhibitor, against three physician-selected comparator arms. Those comparator options include pembrolizumab, the combination of ipilimumab and nivolumab - ipi/nivo - or dacarbazine. Randomization is conducted at a 2:1 ratio in favor of the darovasertib plus crizotinib arm. The PFS analysis was triggered once 130 events had occurred.
If the PFS results are positive, Ideaya intends to pursue an Accelerated Approval filing in first-line HLA-A2-negative metastatic uveal melanoma. The company has completed enrollment of 435 patients in the pivotal Phase 2/3 study, which is explicitly structured to generate data supporting a potential accelerated approval filing in the United States. The broader readout from OptimUM-02 is anticipated to inform regulatory filings and future commercialization strategy, with additional topline results expected to follow into early 2026.
Clinical expectations and investigator commentary
The firm hosted Dr. Marlana Orloff of Jefferson Health and Sidney Kimmel Medical College to discuss the forthcoming topline PFS data. Dr. Orloff, who serves as clinical director in uveal melanoma at Jefferson and has acted as a principal investigator on all studies of darovasertib, signaled optimism. She stated she expects the trial to be positive and projects darovasertib’s PFS to be approximately seven months, mirroring the experience reported in the Phase 1/2 OptimUM-01 study.
Dr. Orloff also commented on the control arm, noting she does not anticipate the comparator therapies to significantly outperform at about five months or less. Her remarks accounted for the increasing uptake of ipi/nivo in the U.S. and the variability in PFS outcomes seen across different studies, but stopped short of forecasting specific comparative results beyond the observations described.
Market and analyst context
Analyst sentiment around Ideaya is broadly favorable. InvestingPro shows a consensus analyst rating of 1.37 and price targets spanning from $31 to $79. Recent coverage adjustments from several firms reflect rising interest in the asset:
- UBS initiated coverage with a Buy rating and set a $50 price target, highlighting the perceived strength of darovasertib in metastatic uveal melanoma and associated sales potential.
- Truist Securities raised its price target to $60 while maintaining a Buy rating, citing the approaching topline PFS readout.
- Citizens reaffirmed a Market Outperform rating and assigned a $45 price target, referencing positive data from the Phase 2 portion of the registrational study.
Despite significant share price gains over the past year, InvestingPro analysis indicates Ideaya is trading near its Fair Value and notes that analysts expect a sales decline in the current year. These financial assessments sit alongside the upcoming clinical catalysts and recent shifts in analyst coverage.
Program rights and partnership changes
Separately, Ideaya will regain rights to two clinical programs as a collaboration with GlaxoSmithKline concludes. The programs, Werner Helicase (IDE275) and Pol Theta (IDE705), will return to Ideaya when the partnership ends, with the transition effective by March 9, 2026.
Implications for investors and sector watchers
The combination of a pivotal trial readout, completed enrollment, evolving analyst coverage, and an improving balance-sheet profile sets a concentrated set of near-term focus points for investors. Market participants will be watching the OptimUM-02 topline PFS announcement and the company’s subsequent regulatory plans closely, while also monitoring how revised analyst price targets align with the company’s cash position and projected revenue trajectory.
Summary
Cantor Fitzgerald's Overweight reaffirmation on Ideaya comes as the company approaches a critical Phase 2/3 PFS readout for darovasertib in first-line metastatic uveal melanoma. The OptimUM-02 trial has completed enrollment and is structured to support an Accelerated Approval filing if the data are favorable. Multiple analysts have adjusted coverage and targets in recent weeks, reflecting heightened interest in the program and the stock.