Quarterly ResultMay 5, 2026, 06:13 AM
IDEAYA Biosciences Darovasertib Trial Meets Endpoint; NDA Submission Planned
AI Summary
IDEAYA Biosciences reported positive topline data from its Phase 2/3 OptimUM-02 registrational trial for darovasertib in combination with crizotinib, meeting its primary endpoint with a 58% reduction in disease progression risk. The company plans to submit a New Drug Application (NDA) in H2 2026 under the FDA's Real-Time Oncology Review program. IDEAYA also provided updates on other pipeline programs and reported Q1 2026 financial results, including $972.9 million in cash, cash equivalents, and marketable securities, with a cash runway into 2030.
Key Highlights
- Darovasertib Phase 2/3 OptimUM-02 trial met primary endpoint, reducing disease progression risk by 58% (HR 0.42).
- Median progression-free survival (PFS) was 6.9 months vs. 3.1 months in control arm.
- Overall response rate (ORR) was 37.1% (5 complete responses) vs. 5.8% in control arm.
- NDA submission for darovasertib combination in 1L HLA*A2-negative mUM planned for H2 2026 under RTOR.
- Cash, cash equivalents, and marketable securities totaled ~$973 million as of March 31, 2026.
- Cash runway guidance remains unchanged into 2030.
- Q1 2026 collaboration revenue was $6.6 million.
- Q1 2026 net loss was $98.5 million.