IDEAYA Biosciences (IDYA) Citigroup’s Biopharma Back to School Summit 2026 summary

Pipeline and clinical development

• Lead asset darovasertib is in late-stage development for metastatic uveal melanoma, with NDA submission nearly complete and commercial launch projected for the first half of next year.

• Two additional phase III studies are ongoing in neoadjuvant and adjuvant settings to expand indications.

• IDE849 (DLL3 Topo ADC) is advancing to a phase III registrational study for small cell lung cancer, with endpoints focused on response rate and overall survival.

• Collaborations with Roche target KRAS mutant pancreatic cancer, leveraging pan-RAS and KRAS G12D inhibitors in combination with PRMT5.

• Multiple assets in the MTAP deletion and CDKN2A space are progressing, with new data and combinations expected to be highlighted at upcoming R&D events.

Regulatory and commercial strategy

• NDA submission for darovasertib is on track for completion this year, with fast track and RTOR designations enabling expedited review.

• FDA feedback suggests potential for an HLA-agnostic label, evolving from initial plans focused on HLA A2 positive patients.

• Compendia listing is being pursued for neoadjuvant indications, with a decision on the registrational study for OptimUM-10 expected by year-end.

• U.S. commercial launch preparations are underway, with a sales force of about 25 and supply chain readiness; ex-U.S. handled by a partner.

• Early market feedback indicates strong enthusiasm, especially for patients with unmet needs in both A2 positive and negative populations.

Clinical data and differentiation

• Upcoming ESMO presentations will provide updated efficacy and safety data for both darovasertib and IDE849, including response rates, PFS, and OS.

• IDE849 is differentiated by higher response rates and longer PFS compared to competitors, with robust activity in both small cell lung cancer and neuroendocrine carcinoma.

• Dose optimization for IDE849 is ongoing, with two leading doses under evaluation and final selection to be disclosed.

• Combination strategies in pancreatic cancer include doublets and triplets with pan-RAS, PRMT5, and CDKN2A assets, aiming to address large patient populations.

• KAT6/7 dual inhibitor is in dose escalation, targeting breast, CRC, and lung cancers, with potential for monotherapy activity and combinations.