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Adagene Announces FDA Fast Track Designation for Muzastotug (ADG126)
Designation underscores the potential of SAFEbody®-enabled anti-CTLA-4 therapy to address unmet need in MSS colorectal cancer SAN DIEGO and SUZHOU, China, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has designated muzastotug, in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD
About this update from Merck & Company, Inc.
[{"type":"image","alt":"Adagene Inc.","displaySize":"","headline":null,"caption":"Adagene Inc.","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":263,"url":"https://media.zenfs.com/en/globenewswire.com/af1c524f33a5b0ab58b78f30aa6d36d7"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/pI3DpScLq.GcBgxWGZ9SEw--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTM2ODtjZj13ZWJw/https://media.zenfs.com/en/globenewswire.com/af1c524f33a5b0ab58b78f30aa6d36d7","width":300,"height":263}},"lazy":false},{"type":"text","content":"Designation underscores the potential of SAFEbody®-enabled anti-CTLA-4 therapy to address unmet need in MSS colorectal cancer","length":125,"tagName":"p"},{"type":"text","content":"SAN DIEGO and SUZHOU, China, Dec. 16, 2025 (GLOBE NEWSWIRE) -- Adagene Inc. (“Adagene”) (Nasdaq: ADAG), a company transforming the discovery and development of novel antibody-based therapies, today announced that the U.S. Food and Drug Administration (FDA) has designated muzastotug, in combination with Merck’s (known as MSD outside of the United States and Canada) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), 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.","length":815,"tagName":"p"},{"type":"text","content":"The Fast Track Designation is supported by emerging clinical evidence demonstrating encouraging efficacy, deep and durable responses, and a favorable safety profile of muzastotug across a heavily pretreated patient population. Fast Track is designed to facilitate drug development and expedite the review of therapies intended to treat serious conditions with unmet medical need.","length":379,"tagName":"p"},{"type":"text","content":"“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, Ph.D., Chief Executive Officer and President of R&D at Adagene. “We are deeply encouraged by the responses we are seeing with muzastotu...