Tiziana Doses First ALS Patients in Phase 2a BANYAN Trial of Intranasal Foralumab
TLSA sits 31% above its 52-week low of $0.762.
Summary
Tiziana has dosed the first three participants in its Phase 2a BANYAN trial of intranasal foralumab for ALS. The trial will enroll 44 early ALS patients, randomized 3:1 to drug or placebo, with a 12-week treatment period followed by a 12-week extension. Primary endpoint is safety and tolerability; secondary endpoints include Treg induction, gene expression, NfL levels, and microglial activation via TSPO-PET/MRI. This milestone expands foralumab's clinical footprint beyond MS, MSA, and AD into ALS, a high-unmet-need indication. The trial is co-funded by the ALS Association and conducted at Healey & AMG Center and other sites. A community webinar is scheduled for October 1 to discuss the science. This follows recent insider buying by the CEO and Executive Chairman, signaling management confidence. The stock is micro-cap (~$130M), so any positive clinical news can move the price significantly.
Updates
· SEC 6-K — The 6-K attaches the press release announcing the first three participants dosed in the BANYAN trial.
At the time of this announcement, TLSA was trading at $1.00 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $129.6M. The 52-week trading range was $0.76 to $2.35. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: GlobeNewswire.