Foralumab (intranasal)

Tiziana is a small Nasdaq-listed biotech that issues its news from Boston and whose pipeline is built around foralumab, tested in multiple sclerosis, Alzheimer's disease, multiple system atrophy and ALS. In January 2026 it raised $8.8 million. The ALS trial is co-funded by the ALS Association through a $1 million Hoffman award, with extra support from two ALS foundations.

Foralumab attaches to CD3, a marker on immune T cells. Given in small doses through the nose, it is meant to boost regulatory T cells (Tregs), immune cells that calm inflammation, which then travel to the brain and spinal cord. Inflammation from immune cells called microglia is thought to speed up ALS. In multiple sclerosis studies the spray reduced signs of microglia activity on brain scans.

Tiziana filed its US trial application for ALS in March 2025. The trial was accepted into the Healey ALS MyMatch programme at Mass General Brigham in November 2025, and the first three participants were dosed in September 2026. The trial was first described as a 20-person study and has grown to 44 people.

BANYAN is the first clinical study of foralumab in ALS, so there is no evidence yet that it helps in ALS. Its main goal is safety. It will also look at immune cells, the nerve-damage marker NfL, and brain inflammation on PET scans, not at whether people decline more slowly.

This is the most favourable result reported. See all key studies for the full picture.

BANYAN is enrolling adults aged 18 to 75 whose first symptoms began within the last 24 months, whose breathing capacity is at least 65% of normal, and whose blood NfL level is at least 40 pg/mL. Three in four people get foralumab and one in four placebo for 12 weeks, then everyone gets foralumab for 12 more weeks. The spray is used three times a week, two weeks on and one week off, mostly at home.

The trial registry estimates the main data will be collected by July 2027 and the study will finish in November 2027. Tiziana itself has not given a date for results.

BANYAN is run through Healey ALS MyMatch, which screens people at Mass General in Boston, Northwestern in Chicago, the University of Minnesota and Nova Southeastern in Florida. The registry lists it as enrolling by invitation, meaning people join through these centres' screening rather than by signing up directly. We found no expanded access for ALS.

• BANYAN (Phase 2a) (NCT07688239) enrolling by invitation · Boston MA, Chicago IL, Minneapolis MN, Davie FL