Also known as: CLE
Alumis reported that 54% of psoriasis patients achieved complete skin clearance (PASI 100) at 48 weeks in the ONWARD3 study, with 75% achieving PASI 90. The company plans to submit an NDA for envudeucitinib in Q4 2026.
InnoCare's TYK2 inhibitor fadeucravacitinib met primary and secondary endpoints in a Phase 3 psoriasis trial, with a favorable safety profile. InnoCare plans to seek regulatory approval.
Three FcRn inhibitors are approved for generalized myasthenia gravis, with a head-to-head trial of efgartigimod and nipocalimab underway. Emerging therapies including telitacicept, gefurulimab, and CAR-T cell therapy (KYV-101) show promise, while Immunovant's batoclimab failed TED trials.
January and March 2026 drug pipeline updates included Phase 3 results, Fast Track designations and Priority Review decisions across multiple disease areas. Mavacamten, teplizumab-mzwv, anifrolumab, AXS-05, gedatolisib and AFTX-201 were among the programs with notable milestones.
Biogen announced that litifilimab received FDA Breakthrough Therapy Designation for cutaneous lupus erythematosus and will present Phase 2 AMETHYST study results at the 2026 AAD Annual Meeting, with Phase 3 data expected in 2027.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07355218 |
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2) |
RECRUITING | PHASE3 |
| NCT06015737 |
A Phase III Study to Investigate the Efficacy and Safety of Anifrolumab in Adults With Chronic and/or Subacute Cutaneous Lupus Erythematosus |
ACTIVE_NOT_RECRUITING | PHASE3 |
