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Halcyon Therapeutics reports positive Phase 2 results for HLX-204 in chronic kidney disease

Halcyon Therapeutics reported topline Phase 2 data for HLX-204, with a 32% relative reduction in the primary composite endpoint over 24 weeks.

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BOSTON, MA, UNITED STATES — October 20, 2026

Halcyon Therapeutics today reported topline results from its Phase 2 trial of HLX-204 in adults with stage 3 chronic kidney disease and type 2 diabetes. The trial met its primary endpoint, with a 32% relative reduction in the composite of eGFR decline and hospitalisation over 24 weeks compared with placebo (p=0.0031).

The trial enrolled 412 participants across 38 sites in the United States and Europe. Adverse events were reported in 41% of participants receiving HLX-204 versus 39% in the placebo arm, with the most common being mild gastrointestinal events.

Halcyon said it will present the full dataset at the American Society of Nephrology annual meeting in November and plans to begin a Phase 3 programme in the first half of 2027.

“These are mid-stage results in a population with few options and a well-documented rate of decline. The Phase 3 design is the next real question.”

— Dr. Elena Márquez, Chief Medical Officer, Halcyon Therapeutics

About Halcyon Therapeutics

Halcyon Therapeutics is a clinical-stage biotechnology company developing therapies for metabolic and renal disease. The company is headquartered in Boston.

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The trial met its primary endpoint with a 32% relative reduction in a composite of eGFR decline and hospitalisation over 24 weeks versus placebo, with p=0.0031, in 412 participants.

Adverse events were reported in 41% of participants receiving HLX-204 versus 39% on placebo, most commonly mild gastrointestinal events.

Halcyon plans to begin a Phase 3 programme in the first half of 2027 and will present the full dataset at the ASN annual meeting in November 2026.

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