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Autoimmune-Summaries: Daily Autoimmune Updates at a Glance

  • decodeMR Team
  • 10 hours ago
  • 2 min read

10/02/2026













US FDA accepted NDA and granted priority review for Takeda’s oveporexton as a potential first-in-class therapy for Narcolepsy Type 1 (Ref)


The US FDA accepted the New Drug Application (NDA) and granted Priority Review to Takeda’s oveporexton (TAK-861; an oral, OX2R-selective agonist) for the treatment of patients with narcolepsy type 1 (NT1)


  • The NDA filing was supported by a comprehensive data package, including two Phase 3 studies: FirstLight (TAK-861-3001/ NCT06470828) and RadiantLight (TAK-861-3002/ NCT06505031) 


  • The FDA set a Prescription Drug User Fee Act (PDUFA) target action date in Q3 2026


















Evommune reported positive top-line data from Phase 2a POC trial of  EVO301 in moderate-to-severe atopic dermatitis (Ref)


Evommune announced positive results from its Phase 2a/ NCT06723405 randomized, double-blind, placebo-controlled trial evaluating EVO301 (anti-IL-18 mAb) in patients with moderate-to-severe atopic dermatitis (AD)


  • The trial met its primary endpoint of EASI at week 12. The safety profile was generally well-tolerated, with no treatment related serious or severe adverse events and no treatment-related discontinuations


  • Biomarker analysis showed significant reductions in both Th2 and non-Th2 inflammatory biomarkers in AD, including CCL-17 (TARC), CCL-22, and IL-22


  • Full results from the Phase 2a trial were planned to be presented at a future scientific conference


  • The Company continued advancing plans for a Phase 2b dose‑ranging trial in patients with AD, using a subcutaneous formulation of EVO301



















Kincell Bio partnered with Regcell to advance Treg cell therapies into clinical trials for autoimmune diseases (Ref)


Kincell Bio announced a collaboration with Regcell to support the development and manufacturing of RegCell’s lead regulatory T-cell (Treg) therapy program, advancing it toward clinical trials for autoimmune diseases


  • Under the partnership, Kincell Bio agreed to provide comprehensive CMC development and GMP manufacturing support to accelerate RegCell’s lead Treg program into clinical trials


  • RegCell agreed to transfer its lead Treg program to Kincell Bio for process and analytical transfer and development, optimization of a scalable manufacturing process, and GMP clinical material supply to support IND‑enabling activities and clinical trials


  • The collaboration aimed to streamline development timelines and ensure robust clinical supply for RegCell’s novel epigenetic reprogramming platform

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