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 |
|---|---|---|---|
| NCT05531565 |
A 2-Part Study to Learn Whether Litifilimab (BIIB059) Injections Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus |
ACTIVE_NOT_RECRUITING | PHASE2/PHASE3 |
| NCT05352919 |
An Extension Study to Learn More About the Long-Term Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Systemic Lupus Erythematosus |
ENROLLING_BY_INVITATION | PHASE3 |
