Adagene shares jump 10.18% premarket after FDA grants Fast Track to muzastotug-Keytruda combo for MSS colorectal cancer.

Adagene Inc. (Nasdaq: ADAG) surged 10.18% in premarket trading following the U.S. Food and Drug Administration’s (FDA) Fast Track Designation for muzastotug (ADG126) in combination with Merck’s KEYTRUDA for adult patients with microsatellite stable metastatic colorectal cancer (MSS mCRC). The designation highlights muzastotug’s potential to address unmet medical needs through its proprietary SAFEbody® technology, which enhances safety and efficacy by targeting tumor-specific Treg resistance. The news reinforced Adagene’s progress in advancing its pipeline, with Phase 2 trials underway and a planned Phase 3 trial starting in 2027. The FDA’s endorsement, coupled with emerging clinical data showing durable responses and favorable safety profiles in pretreated patients, likely drove investor optimism about the therapy’s commercial potential and expedited regulatory pathways.