Darovasertib

Ideaya Biosciences Inc. hit a 52-week low at $24.38 amid a 29.29% stock decline, yet maintains strong finances and advances in cancer precision medicine. Analysts remain optimistic, with price targets up to $65. Recent developments include a license agreement for SHR-4849, Phase 1 trials for IDE161, and IDE251 nomination, despite a downgrade by Leerink Partners.

IDEAYA Biosciences announced the IDMC's recommendation of a move-forward dose for their potential registration-enabling phase 2/3 trial evaluating darovasertib and crizotinib in first-line HLA-A2(-) metastatic uveal melanoma patients, aligning with FDA's Project Optimus guidelines. The combination has shown compelling preliminary clinical results and has FDA Fast Track designation.

IDMC recommends move-forward dose for darovasertib and crizotinib combination in 1L HLA-A2(-) MUM trial, with over 185 patients enrolled. The combination has FDA Fast Track designation and shows promising clinical efficacy and safety.

IDEAYA Biosciences announced IDMC recommended a move-forward dose for Part 2a of their trial evaluating darovasertib and crizotinib in first-line HLA-A2-negative metastatic uveal melanoma, with over 185 patients enrolled and FDA Fast Track designation.

IDEAYA Biosciences announced the nomination of its new development candidate, IDE251, a potential first-in-class dual inhibitor targeting KAT6 and KAT7 implicated in certain cancers. The company plans to submit an Investigational New Drug application to the FDA in 2025, contingent on successful preclinical and IND-enabling studies. IDE251 has shown robust anti-tumor activity in preclinical studies, particularly in tumor models with 8p11 amplifications. IDEAYA Biosciences focuses on targeted therapeutics for cancer, emphasizing molecular diagnostics and synthetic lethality.

Ideaya Biosciences Inc. stock hit a 52-week low of $25.16, down from $47.73. Despite a FAIR financial health rating and strong liquidity, shares fell 25.72% over a year. Analysts remain bullish with price targets from $27 to $65. IDEAYA initiated a Phase 1 trial for IDE161 with Merck's KEYTRUDA and reported promising data for IDE397. Leerink Partners downgraded the stock due to program uncertainties. UBS, Cantor Fitzgerald, and Goldman Sachs expressed optimism, with Goldman Sachs estimating darovasertib's peak sales at $3.0 billion.

IDEAYA Biosciences appoints Stu Dorman as chief commercial officer to lead transition to commercial launch. Dorman's experience includes global product commercialization at Gilead Sciences. IDEAYA also nominates IDE034, a first-in-class B7H3/PTK7 topo-I-payload biospecific antibody drug conjugate, as a development candidate.

IDEAYA Biosciences appoints Stu Dorman as Chief Commercial Officer, leveraging his 20+ years of oncology commercialization experience from Gilead Sciences and Bristol Myers Squibb, including successful launches of Trodelvy® and Opdivo®.