Mar. 16 at 11:46 AM
Cantor reit'd Top Pick
$IDYA at OW.
$IMCR $IMTX BMY REPL
IDEAYA has guided to a progression-free survival (PFS) readout from the Ph2/3 OptimUM-02 trial of darovasertib (daro; PKC inhibitor) in 1L metastatic uveal melanoma (MUM) by the last week of March.
A positive outcome could support accelerated approval in HLA-A2-negative MUM patients, and de-risk daro's potential in uveal melanoma more broadly, including in neoadjuvant, adjuvant, and HLA-agnositic disease.
Based on our recent investor survey on the PFS topline, most are expecting a positive outcome. The strength of the PFS benefit will likely dictate the stock reaction.
We view PFS >7 months as an upside scenario for shares (+30%). We also expect investors to use the PFS readout as an early indicator for overall survival (OS) in OptimUM-02, which could support full approval. Our investor survey suggests expectations for OS are more mixed. As such, a strong PFS benefit could alleviate concerns ahead of the interim OS analysis in 2027.
