Tiziana Life Sciences Ltd TLSA
Tiziana Life Sciences Ltd (Nasdaq: TLSA) is a CNS/neurology/psychiatry drug developer. Its lead program, Foralumab (TZLS-401), intranasal anti-CD3 mAb, is in Phase 2 for non-active secondary progressive multiple sclerosis; also Alzheimer's, MSA, ALS.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Foralumab (intranasal) - na-SPMS | non-active secondary progressive MS (Phase 2a) | antibody | Phase 2 |
| Foralumab (intranasal) - MSA | multiple system atrophy (Phase 2a) | antibody | Phase 2 |
| Foralumab (intranasal) - Alzheimer's disease | Alzheimer's (Phase 2a) | antibody | Phase 2 |
| Foralumab (intranasal) - ALS | ALS (Phase 2 in ALS MyMatch Program, Mass General Brigham/NEALS; enrollment underway) | antibody | Phase 2 |
| Foralumab (oral) - Crohn's disease | Phase 1b withdrawn in 2022 | antibody | Phase 1 |
| TZLS-501 (anti-IL-6R mAb) | SSc-ILD / inflammatory and oncology indications (deprioritized; IND-enabling studies completed) | antibody | Pre-clinical |
Recent results and decisions
- Oct 16, 2026completed enrollment Last patient began dosing in the Phase 2 placebo-controlled trial of intranasal foralumab in early/mild Alzheimer disease, completing enrollment.
the last patient has begun dosing in its Phase 2 randomized, placebo-controlled clinical trial evaluating intranasal foralumab in patients with early/mild Alzheimer
Filing - Sep 30, 2026submitted Tiziana submitted an FDA request for Orphan Drug Designation for intranasal foralumab in MSA; decision not yet made.
today announced that it has submitted a request to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for intranasal foralumab for the treatment of Multiple System Atrophy (MSA).
Filing - Sep 28, 2026started First three participants dosed in the Phase 2a BANYAN trial of intranasal foralumab in ALS (44 planned, 3:1 randomization).
today announced that the first three participants have all received their first dose of intranasal foralumab in the Phase 2a Healey ALS MyMatch BANYAN clinical trial.
Filing
4 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.