Shares of Adagene Inc. (NASDAQ:ADAG) jumped more than 16% in pre-market trading on Tuesday after the biotech company said the U.S. Food and Drug Administration has granted Fast Track Designation to its cancer therapy muzastotug when used in combination with Merck’s KEYTRUDA.
The Fast Track designation covers the treatment of adult patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) who do not have current or active liver metastases. The regulatory status is intended to speed up the development and review of therapies aimed at serious diseases with significant unmet medical needs.
Muzastotug is a next-generation, masked anti-CTLA-4 SAFEbody designed to improve safety while overcoming resistance mechanisms in tumors. Adagene said the FDA’s decision was supported by clinical data demonstrating encouraging efficacy along with a favorable safety profile in heavily pretreated patients.
“Receiving Fast Track Designation marks an important milestone for Adagene and further validates the promise of our SAFEbody technology to unlock CTLA-4 biology in a fundamentally safer and more effective way,” said Peter Luo, CEO and President of R&D at Adagene.
Looking ahead, the company plans to release updated topline results from its Phase 1b/2 study in the coming months, while continuing enrollment in its ongoing randomized Phase 2 trial. Adagene is also preparing for a registration-focused study, which is expected to begin in 2027.
The FDA has already confirmed the design and primary endpoints for both the Phase 2 and Phase 3 programs. Under the Phase 2 study, patients will be randomized to receive either 10 mg/kg or 20 mg/kg of muzastotug alongside pembrolizumab, while the Phase 3 trial will use overall survival as its main endpoint.