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
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.