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IDYABullishIndustry Newsnews

High materiality8/10

IDEAYA targets Phase 3 start for IDE849 in ES-SCLC after FDA Type C meeting

Aug 31, 2026, 6:06 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Regulatory-directed Phase 3 initiation, clear endpoints, and upcoming data milestones typically generate positive re-rating potential for a biotech with a high-growth, late-stage program.

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What happened, with direct paths to the underlying reporting

IDEAYA announced a successful FDA Type C meeting to shape IDE849’s Phase 3 registrational trial in extensive-stage small cell lung cancer (ES-SCLC). The study aims to enroll ~400 patients, randomizing IDE849 against an investigator's choice, with ORR by BICR for accelerated approval and median OS for full approval as endpoints. Data updates at ESMO 2026 and late-2026 progress may support a best-in-class profile and potential combination strategies with Imfinzi and IDE161.

FDA Type C meeting confirms IDE849 Phase 3 design; initiation targeted by year-end 2026.
Phase 3 enrollment ~400 ES-SCLC; randomized 1:1 vs investigator's choice.
ORR by BICR for accelerated approval; OS for full approval as primary endpoints.
RP3D doses being evaluated: 2.4 mg/kg and 3.5 mg/kg IV every 3 weeks.
ESMO 2026 and Q4 2026 data updates to support a best-in-class profile.

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