IDEAYA Biosciences (IDYA) highlighted progress on its darovasertib program at the Wells Fargo Healthcare Conference on September 8, 2026, as the company nears submission of its final New Drug Application (NDA) module under the Real-Time Oncology Review (RTOR) pathway. The drug, designated a Breakthrough Therapy, targets metastatic uveal melanoma (MUM), a rare cancer affecting roughly 1,500 incident patients annually in the U.S. The company anticipates a potential launch earlier than the previously expected first-half 2025 timeline, pending regulatory approval.
Darovasertib is being evaluated in the OptimUM-02 Phase 3 study, with interim overall survival (OS) data expected mid-2025. Meanwhile, the neoadjuvant Phase 3 study, OptimUM-01, has faced enrollment delays due to stricter eligibility criteria, such as plaque size restrictions, which have reduced screen success rates. IDEAYA expects decisions on this study’s trajectory by the next quarter, with potential capital reallocation of up to $100 million toward earlier-stage programs if the study is discontinued or modified.
The company’s pipeline also includes a DLL3-targeting program in collaboration with Hansoh Pharmaceuticals, which is set to begin Phase 3 registrations by year-end 2024. IDEAYA has aligned dosing with Hansoh at 2.4 mg/kg intravenously every three weeks, with the FDA’s support on two dose levels. ESMO data for the DLL3 program, expected to include around 100 patients, will provide response rates, progression-free survival (PFS), and 12-month landmark OS insights.
IDEAYA’s broader pipeline includes PRMT5 (IDEAYA 892), which has demonstrated target EC90 coverage over 24 hours, and a CDKN2A inhibitor program expected to enter clinical testing in the first half of 2025. The company also collaborates with Roche and Genentech on Pan-RAS and KRAS G12D inhibitor combination studies.
Stock performance reflected investor interest: IDEAYA’s shares closed at $38.91 on September 8, down 2.38% from the previous day, with a 52-week high of $42.68 and a one-year return of 70%. The market capitalization stood at $3.76 billion, and current ratio was 10.45. Wall Street analysts set price targets ranging from $31 to $65, with a median expectation of $45.
IDEAYA’s CEO, Yujiro, emphasized progress on darovasertib, stating that the first three NDA modules had been submitted and the final module was imminent. CCO Stu echoed optimism about the label’s potential to cover all MUM patients, noting that overall survival remains the gold standard in oncology. The company framed the asset as a potential blockbuster opportunity, underscoring its strategic focus on advancing multiple programs in the rare cancer space.
