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.
Price: 1.34, Change: -0.06, Percent Change: -4.29
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