IDEAYA Biosciences (IDYA) shared pipeline updates at Citigroup’s Biopharma Back to School Summit on September 10, 2026, as its shares closed at $37.91, down 1.16% from the prior day’s $38.35. With a market capitalization of $3.66 billion and a 55% year-to-date return, the company’s stock remains within its 52-week range of $24.24 to $42.68. Wall Street maintains a strong buy consensus, with price targets suggesting up to a 32% upside from current levels. The focus at the summit centered on Darovasertib, a targeted therapy for metastatic uveal melanoma, and IDE849, a DLL3-targeting antibody-drug conjugate for small cell lung cancer, alongside collaborations with Roche on pancreatic cancer programs.
Darovasertib is advancing through the New Drug Application (NDA) process with a rolling review under Fast Track designation. IDEAYA has submitted three of four NDA modules, with the final module expected by year-end 2024. Commercial launch is targeted for the first half of 2027, though analysts project a first-half 2025 timeline. The drug is being evaluated in both metastatic uveal melanoma and neoadjuvant settings, with ESMO data showing a first-line overall survival (OS) of over 21 months compared to a control arm of 12–13 months. Following FDA feedback, IDEAYA is considering a broader, HLA-agnostic label rather than the originally planned HLA A2-restricted indication. A decision on the neoadjuvant strategy—whether to pursue a full registrational study (OptimUM-11) or a compendia-only approach for NCCN guideline inclusion—is expected by year-end 2024.
IDE849, a Phase III registrational study in extensive-stage small cell lung cancer, is advancing under a Type C meeting framework. The primary endpoint for accelerated approval is overall response rate (ORR), with median overall survival (OS) supporting full approval. The study will enroll post-Imdeltra patients. ESMO data indicate a 6.5-month progression-free survival (PFS) compared to Imdeltra’s ~4.5 months, with a 12-month landmark OS target of over 50%. Dose selection for IDE849 is under review, with finalists including 2.4 mg/kg and 3.5 mg/kg. A neuroendocrine carcinoma (NEC) monotherapy path and potential approval routes will be clarified in a fall 2024 FDA meeting.
IDEAYA’s collaborations with Roche include two programs targeting pancreatic cancer: a PRMT5 inhibitor paired with Roche’s pan-RAS inhibitor, and a PRMT5 inhibitor for Genentech’s KRAS G12D inhibitor. Pancreatic ductal adenocarcinoma (PDAC) patients frequently harbor KRAS mutations (92%), with ~40% of KRAS-mutant cases also having MTAP deletions. Preclinical benchmarks show high response rates for Divarasib plus PRMT5 (94%) and zoldonrasib plus PRMT5 (62%). IDE892, a PRMT5 inhibitor, is expected to enter clinical trials in the first half of 2025.
The KAT6/7 program, a dual inhibitor, is in dose escalation, with preclinical data showing superior activity over Pfizer’s single-inhibitor approach across breast, colorectal, and lung cancer models. A significant data update is anticipated by year-end 2024. IDEAYA also leveraged artificial intelligence in drug discovery, regulatory work, commercial operations, and internal efficiency, utilizing platforms like ChatGPT, Claude, and Copilot for tasks such as protein structure analysis, document assembly, and competitive intelligence.
Yujiro Hata, CEO and Founder, and Josh Bleharski, CFO, discussed the pipeline’s momentum, while Daniel Simon, Chief Business Officer, highlighted strategic partnerships and regulatory progress. The summit underscored IDEAYA’s focus on broadening its oncology portfolio and optimizing commercial readiness for key programs.
