Adagene announces FDA fast track designation for muzastotug

Adagene (ADAG) announced that the U.S. Food and Drug Administration, FDA, has designated muzastotug, in combination with Merck’s (MRK) anti-PD-1 therapy, KEYTRUDA, as a Fast Track product for adult patients with microsatellite stable metastatic colorectal cancer, MSS mCRC, without current or active liver metastases. Muzastotug is a next-generation masked anti-CTLA-4 SAFEbody engineered to overcome CTLA-4-mediated Treg resistance in tumors with enhanced safety and efficacy, delivering a therapeutic index beyond the reach of existing CTLA-4 therapies.