IDEAYA Files First Darovasertib NDA, Closes Phase 3 Trial

The Tip Desk · November 4, 2026 · 3 min read

Cash, cash equivalents and marketable securities stood at $1.15 billion as of September 30, 2026, with runway guidance into 2030 unchanged.

IDEAYA Biosciences (IDYA), a precision medicine oncology company, completed its first new drug application in the third quarter ended September 30, 2026, seeking U.S. approval of darovasertib plus crizotinib in metastatic uveal melanoma under the FDA’s Real-Time Oncology Review program.

The filing closed a sequence that began in the first quarter, when the company reported that the registrational OptimUM-02 trial had met its primary endpoint and that an NDA was planned for the second half of 2026. In the second quarter it said the submission was underway. During the third quarter it finished the package.

Chief Executive Officer Yujiro S. Hata said the company was “encouraged by the continued momentum” in the quarter, marked by that first NDA filing.

At ESMO 2026 IDEAYA presented OptimUM-01 expansion data in 101 HLA-A*02:01-positive metastatic uveal melanoma patients and an OptimUM-02 update in HLA-A*02:01-negative patients, saying the results supported the darovasertib combination across the uveal melanoma treatment journey regardless of HLA status or line of therapy. In primary uveal melanoma, follow-up OptimUM-09 data in about 119 patients showed more than 85% of treated patients with tumor shrinkage, a 57% eye-preservation rate in the enucleation cohort, and 74–79% of plaque-brachytherapy patients achieving a reduced predicted radiation dose to critical eye structures.

The company also stopped enrollment and closed Phase 3 OptimUM-010 in primary uveal melanoma, citing site activation and enrollment challenges. It said the closure is expected to produce $100 million to $125 million in cost savings to reallocate to other programs, including potential registrational trials of IDE849 and IDE892. After a Type C meeting, IDEAYA and partner Les Laboratoires Servier initiated global Phase 3 OptimUM-011 of the darovasertib combination in adjuvant primary uveal melanoma, planned for about 450 patients.

Collaboration revenue for the three months ended September 30, 2026 was $10.2 million, compared with $8.9 million in the prior quarter, still tied to Servier darovasertib research and development services. Remaining performance obligations for those services were $139.8 million.

Research and development expenses were $121.6 million, up from $108.7 million, which the company attributed primarily to higher clinical trial and development costs and personnel-related expenses. General and administrative expenses were $26.3 million, compared with $22.5 million, which it attributed primarily to personnel costs and darovasertib commercial preparation. Net loss was $125.7 million, or $1.22 a share, compared with a net loss of $112.5 million, or $1.22 a share, in the prior quarter.

Cash, cash equivalents and marketable securities were $1.15 billion as of September 30, 2026, down from $1.24 billion as of June 30, 2026, a decrease the company said was primarily driven by net cash used in operations. Cash runway guidance into 2030 remained unchanged based on the current operating plan.

On antibody-drug conjugates, Hengrui presented Phase 1 IDE849 data in relapsed small cell lung cancer and neuroendocrine carcinomas, including median overall survival of 17.4 months in second-line SCLC. IDEAYA said it plans to report first clinical data from its global Phase 1/2 IDE849 monotherapy trial by the end of 2026 or early 2027 and, after Type C meetings, to initiate two Phase 3 registrational trials in extensive-stage SCLC and NEC by year-end. The ES-SCLC trial is planned for 400 patients with prior tarlatamab treatment.

In the MTAP pathway, IDEAYA entered a Clinical Supply Collaboration Agreement with Genentech to evaluate IDE892 with RG6620 in MTAP-deleted KRAS G12D-mutant pancreatic cancer and is targeting a Roche combination Phase 1 of IDE892 with RG6505 by the end of 2026. The company is hosting an R&D Day on November 16, 2026, and promoted Dr. Michael White to President, Research and Development.