Erasca (ERAS) said Monday that the US Food and Drug Administration has approved an investigational new drug application for ERAS-4001 as a potential treatment for patients with KRAS-mutant solid tumors.

The company said the FDA has cleared both INDs for ERAS-4001 and ERAS-0015 ahead of its guidance, allowing it to proceed with the product candidates' development.

Erasca said the phase 1 trial of ERAS-4001 in patients with KRAS-mutant solid tumors will evaluate its safety, tolerability, and preliminary efficacy. The company said it is also evaluating ERAS-0015 in under a phase 1 trial in patients with RAS-mutant solid tumors.

Initial phase 1 monotherapy data for both programs are expected in 2026, Erasca said.

Shares of Erasca were down more than 4% in recent Monday trading.

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