Adagene Reports Positive Full Year 2025 Results, Provides Corporate Update

Biotech company highlights progress of lead candidate muzastotug, plans for 2026 and beyond

Apr. 2, 2026 at 7:20am

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Adagene Inc. reported financial results for the full year 2025 and provided updates on its clinical pipeline, including positive data for its lead candidate muzastotug in combination with pembrolizumab for microsatellite stable colorectal cancer. The company also outlined key objectives for 2026, including data readouts, enrollment completion for a randomized Phase 2 trial, and establishing new collaborations, while projecting a cash runway into early 2028.

Why it matters

Adagene's progress with muzastotug, a masked anti-CTLA-4 antibody, demonstrates the potential of its SAFEbody platform to improve the therapeutic index of immuno-oncology agents. Positive results in hard-to-treat colorectal cancer and liver cancer could position muzastotug as a foundational combination therapy, while the company's collaborations highlight the broad applicability of its technology.

The details

Key 2025 data for muzastotug included a 29% confirmed overall response rate in the 20 mg/kg dose cohorts for microsatellite stable colorectal cancer, as well as a median overall survival of 19.4 months in the 10 mg/kg cohorts. The company also reported a low 4% discontinuation rate and manageable toxicity profile across all dose levels. Adagene is on track to finalize the optimal combination dose regimen for a potential registrational trial in this indication. The company also plans to present data on muzastotug in triplet combinations for colorectal and liver cancer at the upcoming AACR meeting.

  • In 2025, muzastotug showed positive results in clinical trials.
  • Adagene expects to provide data updates from ongoing studies in 2026.
  • Enrollment in the randomized Phase 2 trial is ahead of plan, with results expected in the first half of 2027.
  • Adagene projects a cash runway into early 2028 based on its current cash position and recent financing.

The players

Adagene Inc.

A platform-driven, clinical-stage biotechnology company transforming the discovery and development of novel antibody-based cancer immunotherapies.

Peter Luo, Ph.D.

Chairman and President of R&D at Adagene.

KEYTRUDA®

Merck's anti-PD-1 therapy that Adagene is studying in combination with muzastotug.

Sanofi

A collaborator that has invested up to $25 million to support Adagene's randomized Phase 2 study of muzastotug.

Roche

A collaborator sponsoring and conducting a Phase 1b/2 trial evaluating muzastotug in combination with atezolizumab and bevacizumab in first-line hepatocellular carcinoma.

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What they’re saying

“Our clinical data for muzastotug plus pembrolizumab consistently demonstrate potent, dose-dependent efficacy.”

— Peter Luo, Ph.D., Chairman and President of R&D at Adagene

What’s next

Adagene plans to complete enrollment of the ongoing randomized Phase 2 dose-optimization study with muzastotug, provide preliminary data from an investigator-initiated neoadjuvant trial, present initial data from a new triplet combination cohort, and share results from its collaboration with Roche evaluating muzastotug in liver cancer.

The takeaway

Adagene's progress with its lead candidate muzastotug, including positive clinical data and an expanding pipeline of combination regimens, demonstrates the potential of its SAFEbody platform to improve the therapeutic index of immuno-oncology agents and establish muzastotug as a foundational combination therapy in hard-to-treat cancers.