IDEAYA advances darovasertib toward NDA following landmark clinical success

IDEAYA Biosciences (NASDAQ:IDYA) marked a milestone first quarter in 2026, transitioning into a late-stage regulatory company following a decisive clinical win in its lead oncology program and the initiation of a rolling New Drug Application (NDA).

The South San Francisco-based precision medicine company announced that its Phase 2/3 OptimUM-02 trial, evaluating the darovasertib and crizotinib combination in first-line HLA*A2-negative metastatic uveal melanoma (mUM), met its primary endpoint.

The regimen demonstrated a statistically significant improvement in median progression-free survival (PFS) of 6.9 months compared to 3.1 months for investigator-choice therapy.

Most notably, the combination reduced the risk of disease progression by 58% (Hazard Ratio: 0.42).

On the strength of these results, the U.S. Food and Drug Administration (FDA) has agreed to review IDEAYA’s NDA under the Real-Time Oncology Review (RTOR) program.

The company expects to begin pre-submissions this month and complete the full filing in the second half of 2026, targeting potential accelerated approval.

Financially, IDEAYA ended the quarter with a formidable balance sheet, reporting $972.9 million in cash, cash equivalents, and marketable securities as of March 31, 2026.