Also known as: relapsing MS
Immunic reported first-quarter 2026 results and said a $200 million upfront private placement is expected to fund phase 3 ENSURE trials in relapsing MS. The financing could provide up to $400 million in gross proceeds.
The EMA’s CHMP recommended approval of Sanofi’s Cenrifki (tolebrutinib) for non-relapsing secondary progressive multiple sclerosis. The phase 3 HERCULES study showed reduced disability progression, while liver injury remains an identified safety risk.
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.
The FDA approved ScinoPharm Taiwan's glatiramer acetate as the first complex injectable generic for relapsing multiple sclerosis and Sentynl Therapeutics' copper histidinate as the first treatment for pediatric Menkes disease in January 2026. These approvals represent significant advancements in neurological care, with the glatiramer acetate approval following a novel regulatory pathway and the Menkes treatment showing improved survival in early-treated patients.
AI-powered drugmaker Earendil Labs secured $787 million to advance biologics for autoimmune diseases and cancer, while Immunic locked in up to $400 million to fund Phase 3 trials of its multiple sclerosis therapy.
Immunic Inc presented additional data from its Phase 2 CALIPER trial at the ACTRIMS Forum, showing Vidofludimus calcium reduced both acute and chronic brain lesions in progressive multiple sclerosis patients and demonstrated clinical evidence of reduced EBV reactivation.
A Phase 1 trial of azer-cel, a CAR T-cell therapy using donor T-cells to target B-cells, is recruiting patients with progressive multiple sclerosis at eight U.S. sites. Separately, multiple randomized trials are comparing hematopoietic stem cell transplantation against high-efficacy disease-modifying therapies.
Phase III FENtrepid trial results show investigational BTK inhibitor fenebrutinib met its primary endpoint of non-inferiority to ocrelizumab in primary progressive MS, with a 12% reduction in disability progression risk and strongest effect on upper limb function.
Immunic announced an oversubscribed private placement of up to $400 million to complete phase 3 trials of vidofludimus calcium in relapsing multiple sclerosis, initiate a phase 3 program in primary progressive MS, and transition to a commercial organization.
Immunic announced an oversubscribed private placement of up to $400 million to complete Phase 3 trials of vidofludimus calcium in relapsing multiple sclerosis, initiate a Phase 3 trial in primary progressive MS, and transition into a commercial organization.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07483450 |
A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis |
RECRUITING | PHASE4 |
| NCT07220252 |
Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07211633 |
A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, Radiological and Clinical Effects of Subcutaneous Ublituximab in Participants With Relapsing Multiple Sclerosis (RMS) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT07161258 |
A Pharmacokinetics (PK), Pharmacodynamics (PD), Safety and Tolerability Study of Fenebrutinib in Children and Adolescents With Relapsing Multiple Sclerosis (RMS) |
RECRUITING | PHASE2 |
| NCT07138833 |
A Phase IV Study of Dimethyl Fumarate Enteric-coated Capsules for Relapsing Multiple Sclerosis (RMS) |
NOT_YET_RECRUITING | PHASE4 |
| NCT06847724 |
Comparative PK, PD, Efficacy, and Safety Assessment of the Proposed Ocrelizumab Biosimilar CYB704 and Ocrevus in Participants With Relapsing Multiple Sclerosis |
RECRUITING | PHASE3 |
| NCT06846281 |
Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis. |
RECRUITING | PHASE3 |
| NCT06617793 |
An Open-label Study to Assess the Safety, Efficacy, and Cellular Kinetics of YTB323 in Relapsing Multiple Sclerosis |
RECRUITING | PHASE1/PHASE2 |
| NCT06564311 |
A Study of Obexelimab in Patients With Relapsing Multiple Sclerosis (MoonStone) |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT06529406 |
Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod |
RECRUITING | PHASE4 |
