Tiziana Life Sciences Ltd Com Stock Price, News & Analysis

Tiziana (NASDAQ: TLSA) submitted its seventh annual Development Safety Update Report to the FDA covering Sept 21, 2024–Sept 2, 2025, reporting a cumulative 37.4 patient-years of intranasal foralumab exposure with no drug-related serious adverse events.

Key exposures: 14 naSPMS patients in Expanded Access (50 µg dose) contributed 30.7 patient-years; the TILS-021 randomized trial plus TILS-022 extension added ~5.2 patient-years; one AD patient added 0.5 patient-years. No new risks or safety actions were identified and nasal delivery showed improved tolerability versus prior IV foralumab reports. The company noted an FDA Dec 23, 2025 complete response letter denying approval of Sanofi’s tolebrutinib for nrSPMS and said its Phase 2 naSPMS readout is expected in 2026.

Tiziana Life Sciences (Nasdaq: TLSA) announced that Executive Chairman and Founder Gabriele Cerrone purchased 97,687 common shares on Dec. 19, 2025.

After the purchase his total holding is 43,374,830 common shares, representing 36.08% of issued share capital.

Tiziana Life Sciences (Nasdaq: TLSA) announced that Executive Chairman and Founder Gabriele Cerrone will ring the Nasdaq Closing Bell in Times Square on December 17, 2025 from 3:45 PM to 4:15 PM ET. The ceremony celebrates the company's progress advancing intranasal foralumab, a fully human anti-CD3 monoclonal antibody delivered nasally to target neurodegenerative and inflammatory diseases including multiple sclerosis, Alzheimer's disease, and ALS.

The company noted recent pipeline progress, including dosing the first patient in its Phase 2 Alzheimer's trial, and provided livestream links for the event.

Tiziana Life Sciences (Nasdaq: TLSA) announced that the first patient was dosed on December 17, 2025 in its randomized, placebo-controlled Phase 2 trial of intranasal foralumab for early Alzheimer’s disease.

The trial will evaluate foralumab as monotherapy and combined with FDA-approved anti-amyloid therapies lecanemab (Leqembi) or donanemab, and is supported by TSPO-PET imaging data showing persistent microglial activation after amyloid reduction. The program tests an immunomodulatory approach targeting residual neuroinflammation with intranasal anti-CD3 foralumab; enrollment will continue and clinical outcomes are pending.

Tiziana Life Sciences (Nasdaq: TLSA) announced on December 15, 2025 that its Chief Executive Officer, Ivor Elrifi, purchased 163,400 shares of Tiziana common stock in the open market.

Following this transaction, the CEO's total purchased shares amount to 357,848. The purchase was executed on the open market and reflects an insider buy by the company's chief executive.

Tiziana Life Sciences (Nasdaq: TLSA) announced on Dec 15, 2025 that it has withdrawn its proposed public offering of common shares. The company said the withdrawal was made due to market conditions. The release also states that it does not constitute an offer to sell or a solicitation to buy securities in any jurisdiction prior to required registration or qualification.

Tiziana Life Sciences (Nasdaq: TLSA) announced on Dec 12, 2025 that enrolment has begun in its Phase 2 randomized, placebo-controlled early Alzheimer’s trial and the company expects to dose the first patient next week. The study will test intranasal foralumab as monotherapy and combined with FDA-approved anti-amyloid therapies lecanemab or donanemab.

Baseline cognitive testing, fluid biomarkers and TSPO-PET imaging were completed in initial participants; new TSPO-PET evidence showed persistent, widespread microglial activation in an Alzheimer’s patient despite treatment with lecanemab, supporting the trial rationale to target residual neuroinflammation.

Tiziana Life Sciences (Nasdaq: TLSA) intends to spin out its fully human anti-IL-6 receptor program TZLS-501 into a separately listed, immunology-focused company and will distribute shares in specie to Tiziana shareholders at a record date to be announced. TZLS-501 targets both membrane-bound and soluble IL-6R and was advanced for development due to heightened industry interest in IL-6 therapeutics, noted alongside Novartis' $1.4 billion acquisition of Tourmaline Bio.

The transaction requires shareholder approval and meeting listing criteria; TZLS-501 remains a Tiziana asset until approvals are obtained.

Tiziana Life Sciences (Nasdaq: TLSA) announced on November 25, 2025 that its Phase 2 trial of intranasal foralumab in amyotrophic lateral sclerosis (ALS) was accepted into the Healey ALS MyMatch Program at the Sean M. Healey & AMG Center for ALS at Mass General Brigham.

The study, supported by a competitive grant from the ALS Association, will be led by Principal Investigators Suma Babu and James Berry and will enroll at multiple rapid-enrolling U.S. centers within the NEALS consortium. Successful investigational agents in MyMatch may advance to the HEALEY ALS Platform Trial or to standalone Phase 3 trials. The trial will use nasal immunology, blood and spinal fluid markers, cellular assays, and advanced brain imaging to evaluate foralumab’s effect on regulatory T cells and CNS inflammation.