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83% (78/94) of patients demonstrated ocular tumor shrinkage, with 54% (51/94) achieving ≥20% tumor shrinkage
57% (24/42) eye preservation rate in enucleation (EN) recommended patients, which increased to 95% (19/20) in patients achieving ≥20% ocular tumor shrinkage
70% (26/37) of plaque brachytherapy (PB) eligible patients achieved a reduction in predicted radiation dose to the eye from baseline, resulting in 65% (24/37) of patients having lower predicted risk of vision loss 3-years post-PB treatment
~55% (29/53) of EN eligible and ~61% (23/38) of PB eligible patients demonstrated an improvement in baseline visual acuity scores (VAS) during neoadjuvant darovasertib treatment, with a mean gain of 17 and 10 letters, respectively
Darovasertib has received U.S. FDA Breakthrough Therapy Designation in the neoadjuvant setting of primary uveal melanoma for EN eligible patients
SOUTH SAN FRANCISCO, Calif., Oct. 20, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ:IDYA), a leading precision medicine oncology company, today presented positive clinical data from their ongoing Phase 2 OptimUM-09 trial of neoadjuvant darovasertib in patients with primary uveal melanoma (UM). The data were presented in a Proffered Paper oral presentation by Dr. Marcus Butler, M.D., Associate Professor, Princess Margaret Cancer Center at the University of Toronto, at the 2025 European Society of Medical Oncology (ESMO) in Berlin, Germany. There are currently no approved systemic therapies for patients with primary UM, and there is a critical unmet need for new treatment options that reduce the risk of eye removal and vision loss and have the potential to delay or prevent progression to metastatic disease.
Posted In: IDYA
