IDEAYA trial extends progression-free survival to 6.9 months

• IDEAYA’s OptimUM-02 trial extended median progression-free survival to 6.9 months from 3.1 months.
• IDEAYA shares slipped 0.2% to $35.40 in premarket trading after the update.
• The company is submitting a darovasertib application through the FDA’s real-time oncology review program.

IDEAYA Biosciences (NASDAQ:IDYA) said OptimUM-02 met its primary endpoint, extending median progression-free survival to 6.9 months from 3.1 months.

The 313-patient analysis produced a 0.42 hazard ratio and p-value below 0.0001 against investigator-selected therapy.

Quarterly collaboration revenue was $8.9 million, while R&D expenses reached $108.7 million, G&A expenses $22.5 million and net loss $112.5 million.

Following the announcement, IDEAYA Biosciences' share price was down 0.2% at $35.40 in premarket trading.

IDEAYA ended June with $1.24 billion in cash and securities after raising $323.4 million through a public offering, supporting company guidance for a cash runway into 2030.

The company said its NDA filing is underway under the FDA’s RTOR program and targets completion in H2 2026, alongside further pipeline updates at ESMO.