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Alumis' Envudeucitinib data reinforce 4Q2026 psoriasis NDA timing

Oct 9, 2026, 7:17 PM EDT1 sourcesAI-analyzed
Why it may matterVerify against the original reporting

Positive efficacy signals, best-in-class 54% PASI100, durable scalp/itch outcomes, and a firm 4Q2026 NDA timeline create near-term catalysts with potential for multiple expansion if regulatory risk remains manageable.

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Alumis reports strong ONWARD Phase 3 data for envudeucitinib, including a 54% PASI 100 response at Week 48—the highest among oral psoriasis therapies. Durable scalp clearance, itch relief, and quality-of-life gains support its competitive profile, with NDA submission planned for 4Q2026. Positive safety signals through ONWARD3 further bolster near-term regulatory optimism.

  • Envudeucitinib hits 54% PASI 100 at Week 48; top among oral psoriasis therapies.
  • ONWARD3 shows durable scalp clearance and rapid itch relief across patients.
  • NDA submission for moderate-to-severe plaque psoriasis planned in 4Q2026.
  • Long-term safety remains favorable with no new signals through ONWARD3.
  • ONWARD program enrolled >1,700 patients across ONWARD1/2/3.

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