secwatch / observer

8-K filed June 1, 2026, 4:05 PM ET ticker IDYA CIK 0001676725

other material confidence high sentiment positive materiality 0.80

IDEAYA's darovasertib combo meets primary endpoint in Phase 2/3 OptimUM-02 trial for metastatic uveal melanoma

IDEAYA Biosciences, Inc.

Darovasertib + crizotinib achieved median PFS 6.9 months vs 3.1 months for investigator's choice (HR=0.42, p<0.0001) by BICR, reducing risk of progression by 58%.
Objective response rate 37.1% (combo) vs 5.8% (control) by BICR; disease control rate 73.3% vs 31.1%.
Grade 3/4 TRAEs 40.6% vs 37.0%; treatment-related discontinuations low (darovasertib 2.5%, crizotinib 10.0% vs ICT 19.0%).
FDA agreed to review darovasertib NDA under Real-Time Oncology Review; submission expected in H2 2026.
Overall survival data immature but early trend favoring combo; future analysis will support full approval.

item 7.01 item 8.01 item 9.01

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0001193125-26-251399
form_type: 8-K
ticker: IDYA
cik: 0001676725
company_name: IDEAYA Biosciences, Inc.
filed_at: 2026-06-01T20:05:32+00:00
discovered_at: 2026-06-01T20:08:00.333941+00:00
generated_at: 2026-06-01T20:14:38.995131+00:00
sec_items: ["7.01", "8.01", "9.01"]
event_type: other_material
sentiment: positive
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: high
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text_url: https://secwatch.observer/filing/0001193125-26-251399.txt
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review_status: machine_generated
human_reviewed: false
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correction_note: null
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