Investigational Product: ML261
Indications: Relapsed/refractory small cell lung cancer or select neuroendocrine carcinomas
Regulatory status: Phase 1 clinical development, granted U.S. FDA Fast Track Designation on June 30, 2026
Policy Effective Date: July 15, 2026

Sometimes called “compassionate use,” expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

Moonlight Bio, Inc. is committed to developing safe and effective therapies in the field of DLL3+ cancers and is committed to making them available to patients as quickly as possible. However, at this stage in development, Moonlight Bio is currently not able to make its investigational ML261 therapy available through an expanded (or early) access program. ML261 is in early development, with insufficient safety/efficacy data and limited drug supply to support use outside a controlled trial setting at this time. Access to Moonlight Bio’s ML261 investigational therapy is possible only through participation in a clinical trial. This policy will be reviewed and updated as ML261 development progresses.

Learn more

Patients and families with questions about Moonlight Bio’s investigational therapy, ML261, should speak with their physician or contact the Moonlight Bio Clinical Team at MLTrials@moonlightbio.us. Healthcare providers with questions should contact MLTrials@moonlightbio.us. Additional information regarding Moonlight Bio’s ML261 clinical trial can be found on this website: https://clinicaltrials.gov/study/NCT07488923
Moonlight Bio, Inc reserves the right to revise this policy at any time, in accordance with the 21st Century Cures Act.