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Biogen's litifilimab CLE shows durable skin clearance; Phase 3 readout in 1H 2027

Oct 2, 2026, 11:25 AM EDT1 sourcesAI-analyzed

Why it may matterVerify against the original reporting

Positive 52-week CLE data bolster the litifilimab program; durable efficacy and safety may support a Phase 3 readout-driven rerating, especially with Breakthrough designation already in place.

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What happened, with direct paths to the underlying reporting

Biogen reports 52-week results from the AMETHYST study’s Phase 2 portion in CLE, showing durable skin clearance with litifilimab. At Week 52, CLA-IGA 0-1 was 27.2% and CLASI-70 28.8%, up from Week 24. Crossover patients also improved quickly; Phase 3 readout is expected in the first half of 2027, aided by Breakthrough Therapy designation in 2026.

52-week AMETHYST Phase 2/3 data show durable CLE response.
52 weeks: CLA-IGA 0-1 27.2%, CLASI-70 28.8%.
Crossover group: 33.7% achieved clear or almost clear skin by Week 52.
Phase 3 readout expected in 1H 2027; FDA Breakthrough in 2026.
Safety remains consistent with no new signals; serious AEs 3.4%.

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