Adagene Announces FDA Fast Track Designation for Muzastotug (ADG126)
Adagene Inc. - ADS, each representing 1.25 ordinary shares (ADAG)
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Source: GlobeNewswire
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-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. The Fast Track Designation is supported by emerging clinical ev
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- Adagene (NASDAQ:ADAG) was upgraded by analysts at Guggenheim to a "strong-buy" rating.MarketBeat
- Adagene (NASDAQ:ADAG) is now covered by analysts at Guggenheim. They set a "buy" rating on the stock.MarketBeat
- Adagene (NASDAQ:ADAG) was upgraded by analysts at Lifesci Capital to a "strong-buy" rating.MarketBeat
- Adagene Announces Licensing Agreement with Third Arc Bio for Development of Two Masked CD3 T Cell Engagers Utilizing SAFEbody® Technology [Yahoo! Finance]Yahoo! Finance
- Adagene Announces Licensing Agreement with Third Arc Bio for Development of Two Masked CD3 T Cell Engagers Utilizing SAFEbody® TechnologyGlobeNewswire
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Sec Filings
- 11/14/25 - Form SCHEDULE
- 11/14/25 - Form SCHEDULE
- 11/13/25 - Form 6-K
- ADAG's page on the SEC website