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SAN DIEGO/SUZHOU - Adagene Inc. (NASDAQ:ADAG), a clinical-stage biotech with a market capitalization of $90.49 million, has dosed the first patient in its randomized Phase 2 trial evaluating muzastotug in combination with Merck’s KEYTRUDA for patients with microsatellite stable colorectal cancer (MSS CRC) without liver metastases, the company announced Friday. The stock has gained over 26% in the past six months, though InvestingPro data shows it’s currently trading above its Fair Value.
The open-label study will randomize patients to receive either 10 mg/kg or 20 mg/kg of muzastotug, Adagene’s anti-CTLA-4 SAFEbody therapy, in combination with pembrolizumab. Each arm will enroll up to 30 patients, with overall response rate as the primary endpoint.
According to the company, the trial design follows alignment with the FDA and provides a clear path to Phase 3. Adagene anticipates completing the trial in early 2027, with potential updates expected in 2026.
"We are pleased that the randomized Phase 2 trial is now underway in order to confirm the preferred dose for Phase 3 in compliance with Project Optimus," said Peter Luo, CEO and President of R&D at Adagene.
The company previously reported Phase 1b/2 data at ASCO in June 2025, where patients receiving 20 mg/kg of muzastotug demonstrated a 29% overall response rate compared to 17% in the 10 mg/kg cohort. Median overall survival for the 10 mg/kg cohorts was 19.4 months, while median OS for the 20 mg/kg cohorts had not been reached.
Adagene states that muzastotug has been safely dosed at 20 mg/kg every six weeks, with less than 20% Grade 3 adverse events and no discontinuations, which the company believes supports its potential as a best-in-class Treg-depleting anti-CTLA-4 agent.
The company expects to provide additional updates from the ongoing Phase 1b/2 trial in the coming months, according to the press release statement. Investors should note that Adagene’s next earnings report is scheduled for December 3, 2025, with analysts not anticipating profitability this year. The company’s overall financial health score is rated as WEAK by InvestingPro, which offers 10 additional investment tips on this stock.
In other recent news, Adagene Inc. has been the focus of several analyst updates and strategic appointments. Lucid Capital Markets initiated coverage on Adagene with a Buy rating and set a price target of $9.00, highlighting the company’s potential in antibody-based cancer immunotherapies. H.C. Wainwright adjusted its price target for Adagene to $7.00 from $8.00, maintaining a Buy rating after the company aligned on trial designs for its lead asset, muzastotug, in collaboration with the FDA. Leerink Partners also initiated coverage with an Outperform rating and a $7.00 price target, citing the efficacy of Adagene’s lead program in treating certain colorectal cancers. In addition to these analyst actions, Adagene appointed Dr. Axel Hoos as Executive Advisor. Dr. Hoos brings significant expertise in immuno-oncology, having previously contributed to the development of YERVOY, the first FDA-approved immune checkpoint inhibitor. These developments reflect Adagene’s ongoing efforts to advance its clinical programs and strengthen its strategic positioning in the biotechnology sector.
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