RegulatoryCompany release

IDEAYA completes FDA filing for darovasertib combination in metastatic uveal melanoma

🇺🇸 IDEAYA Biosciences, Inc. (IDYA) · Tue 03 Nov 2026

The company also closed its Phase 3 OptimUM-010 trial in primary uveal melanoma over enrolment problems, as it reported Q3 2026 results and a $1.15 billion cash position.

IDEAYA Biosciences has finished its new drug application (NDA) submission to the US Food and Drug Administration for darovasertib in combination with crizotinib in metastatic uveal melanoma. The company announced the milestone on 3 November 2026 alongside its third-quarter results.

The filing is proceeding under the FDA's Real-Time Oncology Review programme. As general context, that programme is designed to let the agency examine clinical data earlier and more interactively than in a conventional review, with the aim of speeding up assessment of promising cancer therapies.

IDEAYA also said it has closed the Phase 3 OptimUM-010 trial in primary uveal melanoma, citing enrolment challenges. The summary provided does not give further detail on how many patients were enrolled or what the closure means for the primary-disease programme.

Looking ahead, the company plans to start two Phase 3 trials of IDE849, one in small cell lung cancer and one in neuroendocrine carcinoma, by the end of the year. It reported $1.15 billion in cash and left its guidance on cash runway into 2030 unchanged.

What it means for your team

  • Regulatory teams should watch for FDA acceptance of the darovasertib and crizotinib NDA and any signal on review timing under Real-Time Oncology Review.
  • The end of OptimUM-010 means the primary uveal melanoma setting is not currently covered by a Phase 3 trial from the company, based on the information provided.
  • Two planned Phase 3 trials of IDE849 would extend IDEAYA's late-stage work into small cell lung cancer and neuroendocrine carcinoma.

Company's press release (SEC filing): IDEAYA Biosciences, Inc. ↗

Article written by VigiEye from the official source (IDEAYA Biosciences, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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