SC-101 granted ODD by FDA for the treatment of esophageal cancer

On April 27, 2025, Conjustar biologics announced that SC-101 (Nectin-4-targeting PDC) has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of esophageal cancer.

According to the U.S. Orphan Drug Act, the orphan drug designation granted by the FDA applies to drugs intended to treat rare diseases affecting fewer than 200,000 people annually in the United States. It provides policy support for the related products, including but not limited to:

(1) Tax credits for clinical trial costs;

(2) Specific guidance from the FDA for all stages of clinical trail;

(3) Waiver registration fees;

(4) Seven years of market exclusivity;

Therefore, SC-101 granted orphan drug designation by the U.S. FDA that was an important milestone in the development process.