Adagene shares jump 10.18% intraday after FDA grants Fast Track for muzastotug combo in MSS colorectal cancer.

Adagene Inc. (Nasdaq: ADAG) surged 10.18% intraday following the U.S. Food and Drug Administration’s Fast Track Designation for muzastotug in combination with Merck’s KEYTRUDA for treating microsatellite stable metastatic colorectal cancer (MSS mCRC) without active liver metastases. The designation, announced on Dec. 16, 2025, highlights the therapy’s potential to address unmet medical needs, supported by clinical data showing durable responses and a favorable safety profile in pretreated patients. The Fast Track status enables expedited development, including more frequent FDA interactions and rolling review of future marketing applications. Adagene’s proprietary SAFEbody® technology, which enhances safety by targeting tumor-specific activity, underpins the therapy’s differentiation. The news aligns with ongoing Phase 2 trials evaluating dose optimization and plans for a Phase 3 trial with overall survival as the primary endpoint, reinforcing investor confidence in the company’s pipeline advancement.