IDEAYA Biosciences

IDEAYA is preparing regulatory approval and a planned launch of Darovasertib as first-line therapy for metastatic uveal melanoma; three NDA modules have been submitted, the final one is imminent, and the FDA indicated a possible “all-comers” approval. The company is building a lean commercial team (25–30 staff) for a launch in the first half of 2025 and is working on pricing and reimbursement strategies. In parallel, IDE849 (DLL3-TOP1-ADC) is advancing Phase III planning for small cell lung cancer, and the company is pursuing multiple programs in MTAP-, RAS- and CDKN2A-driven tumors, including collaborations with Roche. » Mere på de.investing.com

IDEAYA has filed three of four NDA modules for darovasertib in metastatic uveal melanoma; the final module is imminent and the company is prepared for a possible launch ahead of the currently expected first half of 2025. The neoadjuvant phase‑3 study OptimUM‑01 is being reassessed due to slow enrollment; if modified, about $100m could be reallocated to early‑stage programs. Meanwhile, PRMT5, DLL3, MTAP and CDKN2A programs are progressing, supported by partnerships with Roche, Genentech and Hansoh. IDEAYA expects comprehensive darovasertib data at the ESMO congress and an interim overall survival analysis from OptimUM‑02 in mid‑2025. » Mere på de.investing.com

IDEAYA is collaborating with Genentech to evaluate IDE892 in combination with GDC-7035 (RG6620) in patients with ductal adenocarcinoma of the pancreas who harbor both MTAP deletion and KRAS G12D mutation. Genentech is sponsoring the study and IDEAYA is providing the PRMT5 inhibitor IDE892; both companies will establish a joint steering committee. About 15% of patients are expected to have both alterations, and there are currently no approved targeted therapies for this subgroup. IDE892 is in an ongoing phase 1 study; each company retains commercial rights to its own agent. » Mere på de.investing.com