IDEAYA Biosciences Soars 11.27% on FDA Trial Approval

On May 7, 2025, IDEAYA Biosciences saw a significant rise of 11.27% in pre-market trading, reflecting strong investor interest and confidence in the company's recent developments.

IDEAYA Biosciences, a precision medicine oncology company, has been actively engaged in the discovery and development of targeted therapeutics for specific patient populations. The company's commitment to precision medicine has been a driving force behind its recent advancements.

Oppenheimer recently lowered its price target for IDEAYA Biosciences from $40 to $37, while maintaining an Outperform rating. This adjustment suggests a cautious optimism about the company's future prospects, despite the reduction in the target price.

IDEAYA Biosciences has received clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for IDE849, a potential first-in-class delta-like ligand 3 (DLL3)-targeting Topo-I-payload antibody drug conjugate (ADC) program. This approval is a significant milestone for the company, as it allows for the evaluation of IDE849 in solid tumors, including small cell lung cancer (SCLC), neuroendocrine tumors (NETs), and non-small cell lung cancer (NSCLC).

The ongoing Phase 1 clinical trial for IDE849 has shown promising results, with multiple partial responses observed and predominantly Grade 1 or 2 treatment-related adverse events. The trial is ongoing, with no reported drug-related discontinuations and the maximum tolerated dose yet to be reached. Hengrui Pharma, the company conducting the trial, plans to present clinical efficacy and safety data at a medical conference in the third quarter of 2025.

In addition to IDE849, IDEAYA is also targeting to present preclinical combination mechanism and synergy efficacy data of IDE161/PARG with TOP1-payload based ADCs at a medical conference in the third quarter of 2025. This potential first-in-class combination has the potential to enhance the durability of IDEAYA's TOP1-payload based ADC pipeline, including IDE849 and IDE034 (B7H3/PTK7 Bispecific TOP1 ADC).