Kyverna Therapeutics reports positive long-term follow-up results for its CAR-T therapy miv-cel in generalized myasthenia gravis, with plans to submit a biologics license application in the first half of 2026. The company has $279.3 million in cash providing runway into 2028 to fund launch and Phase 3 trials.
Autolus Therapeutics reported $74.3 million in 2025 revenue during its first commercial year, while facing a -265% gross margin. The company aims to achieve positive margins by 2026 through scaling production and expanding into autoimmune diseases with promising early lupus trial results. The broader CAR-T therapy market is projected to reach $9.85 billion in the US by 2033.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07392879 |
Bringing the Outdoors In: Virtual Nature Walks for Depression in Multiple Sclerosis (MS) Patients |
RECRUITING | NA |
| NCT07282574 |
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS) |
RECRUITING | PHASE2 |
| NCT07139743 |
Obe-cel in Refractory Progressive Forms of Multiple Sclerosis |
RECRUITING | PHASE1 |
| NCT07006805 |
RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT06675864 |
Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease Progression and Cellular Kinetics Following YTB323 Administration in Participants With Non-active Progressive Multiple Sclerosis (PMS) |
RECRUITING | PHASE1/PHASE2 |
| NCT06566261 |
ABA-101 in Participants With Progressive Multiple Sclerosis |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT06485115 |
Telerehabilitation in Progressive Multiple Sclerosis |
NOT_YET_RECRUITING | NA |
| NCT06451159 |
A Study of KYV-101, a CD19 CAR T Cell Therapy, in Participants With Treatment Refractory Progressive Multiple Sclerosis |
ACTIVE_NOT_RECRUITING | PHASE1 |
| NCT06261528 |
Study of Circadian Focused Light Therapy in Progressive Multiple Sclerosis |
ENROLLING_BY_INVITATION | PHASE1 |
| NCT05937802 |
Osmotin Plant Protein for Progressive Multiple Sclerosis |
UNKNOWN | NA |
