Core Viewpoint - Tiziana Life Sciences has initiated a Phase 2 clinical trial for intranasal foralumab, targeting early Alzheimer's disease, marking a significant step in exploring immunomodulatory therapies for neuroinflammation [1][3][7]. Group 1: Clinical Trial Details - The Phase 2 trial is randomized and placebo-controlled, assessing the safety, tolerability, and potential efficacy of intranasal foralumab as both a monotherapy and in combination with FDA-approved anti-amyloid therapies, lecanemab or donanemab [4]. - Primary endpoints of the trial include neuroinflammation measured by TSPO-PET imaging, cognitive function, and changes in amyloid and tau biomarkers, with interim data expected in 2026 [4]. Group 2: Scientific Rationale - TSPO-PET imaging data indicates persistent microglial activation in Alzheimer's patients, even after treatment with anti-amyloid therapies, highlighting the need for therapies that address residual neuroinflammation [2]. - Intranasal foralumab is designed to modulate immune responses and reduce activated microglia, potentially slowing disease progression in early Alzheimer's disease [2][3]. Group 3: Company Insights - Gabriele Cerrone, Chairman & Founder, emphasized the importance of this trial in exploring a novel approach to Alzheimer's treatment, building on previous data showing foralumab's ability to reduce microglial activation in multiple sclerosis patients [3]. - Ivor Elrifi, CEO, expressed enthusiasm for the rapid progress from enrollment to first patient dosing, reflecting the urgent need for new treatment strategies beyond amyloid clearance [3]. Group 4: About Foralumab - Foralumab is a fully human anti-CD3 monoclonal antibody that stimulates T regulatory cells when administered intranasally, with previous studies showing positive outcomes in patients with non-active secondary progressive multiple sclerosis [5][6]. - It is the only fully human anti-CD3 monoclonal antibody currently in clinical development, representing a novel treatment avenue for neuroinflammatory and neurodegenerative diseases [6]. Group 5: Company Overview - Tiziana Life Sciences is a clinical-stage biopharmaceutical company focused on developing innovative therapies using alternative drug delivery technologies, aiming to improve efficacy, safety, and tolerability compared to traditional intravenous delivery methods [6][8].

First Patient Expected to be Dosed Next Week with Intranasal ForalumabPET Scan Shows Presence of Untreated Neuroinflammation in Alzheimer’s Patient on Leqembi® (Lecanemab) Anti-Amyloid Therapy BOSTON, Dec. 12, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, announces that enrolment ...

Core Insights - Eisai Co., Ltd. announced new data on the anti-tau antibody etalanetug (E2814) at the 18th Clinical Trials on Alzheimer's Disease (CTAD) Conference, highlighting its potential in reducing tau pathology in Alzheimer's disease [1][2]. Group 1: Study Findings - The Phase Ib/II study (E2814-103) involved 7 individuals with dominantly inherited Alzheimer's disease (DIAD), showing that tau PET signals were stabilized or trended toward decrease after etalanetug administration, indicating inhibition of tau propagation [2][5]. - Etalanetug demonstrated a reduction in cerebrospinal fluid (CSF) eMTBR-tau243 by 62% at 3 months and 89% at 9 months, while plasma eMTBR-tau243 was reduced by 78% at 3 months and over 90% at 9 months, supporting its mechanism of action [5][6]. Group 2: Biomarker Development - eMTBR-tau243 is a novel biomarker that reflects tau pathology progression, with strong correlations shown between tau PET and eMTBR-tau243 in both plasma and CSF, allowing for easier measurement of tau pathology changes through blood tests [3][4][8]. - The biomarker consists of tau fragments, including tau protein amino acid residue 243, and is thought to arise during the formation of neurofibrillary tangles, a key feature of Alzheimer's disease [4][8]. Group 3: Ongoing Clinical Trials - Etalanetug is currently being evaluated in two ongoing clinical studies: the Tau NexGen Phase II/III trial in DIAD and a Phase II Study 202 for early sporadic Alzheimer's disease, both assessing etalanetug in combination with the standard-of-care antibody lecanemab [6][10]. - In September 2025, etalanetug received Fast Track designation from the U.S. FDA, indicating its potential as a disease-modifying therapy for tauopathies [10].

Core Insights - LEQEMBI IQLIK™, a subcutaneous autoinjector formulation of lecanemab for Alzheimer's disease treatment, has been recognized by TIME as one of the "Best Inventions of 2025" in the Medical and Healthcare category [1][2] Product Overview - LEQEMBI IQLIK is the first anti-amyloid treatment allowing at-home injections, enabling patients to continue treatment after an initial 18-month period [3] - The treatment was approved in the U.S. in August 2025 and launched on October 6, 2025 [3] - It offers a quick administration time of approximately 15 seconds, reducing the need for infusion center visits and associated healthcare resources [3] Clinical Background - LEQEMBI is the first approved anti-amyloid treatment shown to slow cognitive and functional decline in early Alzheimer's disease [4] - It has been approved in 50 countries and is under regulatory review in 10 additional countries [4][28] - The treatment's efficacy was demonstrated in the Clarity AD clinical trial, where it reduced clinical decline on the Clinical Dementia Rating Sum of Boxes (CDR-SB) by 27% at 18 months compared to placebo [29] Safety and Efficacy - The safety profile of LEQEMBI IQLIK is similar to that of the intravenous formulation, with a lower incidence of systemic reactions [31] - Common adverse reactions include infusion-related reactions (26% with LEQEMBI vs. 7% with placebo), ARIA-H (14% vs. 8%), and ARIA-E (13% vs. 2%) [25] - The incidence of amyloid-related imaging abnormalities (ARIA) was observed at 21% for LEQEMBI compared to 9% for placebo [11] Collaboration and Development - Eisai leads the global development and regulatory submissions for LEQEMBI, with Biogen co-commercializing and co-promoting the product [5][33] - The collaboration between Eisai and BioArctic has been ongoing since 2005, focusing on the development of Alzheimer's treatments [34]

Core Insights - Eisai Co., Ltd. and Biogen Inc. have launched the LEQEMBI IQLIK, a subcutaneous injection for Alzheimer's disease maintenance treatment after an initial 18-month intravenous therapy [1][36] - The LEQEMBI Companion program has been introduced to provide additional resources and support for patients throughout their treatment journey [2][3] Group 1: Product Launch and Features - LEQEMBI IQLIK is the first anti-amyloid treatment approved by the U.S. FDA that allows at-home injections after 18 months of intravenous treatment [1] - Patients can choose between continuing intravenous infusions or switching to the new weekly 360 mg subcutaneous injection [1][36] - The LEQEMBI Companion app, developed with Medisafe, offers educational resources and a tracking tool for patients [3] Group 2: Patient Support Initiatives - The LEQEMBI Companion program aims to enhance access to treatment and provide resources for patients with early Alzheimer's disease [2] - Eisai's Patient Assistance Program will offer LEQEMBI at no cost to eligible uninsured and underinsured patients [4] Group 3: Clinical Efficacy and Safety - LEQEMBI targets both amyloid plaques and protofibrils, which are implicated in neurodegeneration [5][9] - Continuing maintenance treatment is essential to slow Alzheimer's disease progression and extend therapeutic benefits [6] - Clinical trials showed that treatment with lecanemab reduced clinical decline by 27% at 18 months compared to placebo [35] Group 4: Collaboration and Development - Eisai leads the global development and regulatory submissions for lecanemab, with Biogen co-commercializing the product [8][39] - The collaboration between Eisai and BioArctic has been ongoing since 2005, focusing on the development of Alzheimer's treatments [40]

Core Thesis - Biogen Inc. is viewed as undervalued with a strong potential for growth driven by its Alzheimer's drug lecanemab and a solid multiple sclerosis franchise [2][4]. Financial Performance - As of September 18th, Biogen's share price was $143.81, with trailing and forward P/E ratios of 13.86 and 9.04 respectively [1]. - The consensus for Q2 revenue is $2.65 billion, reflecting a 3% year-over-year decline, with expected EPS of $3.20 [2]. - Recent real-world data indicated a 25% reduction in hospitalizations, which may lead to an FDA label expansion and increased drug uptake [2]. Pipeline and R&D - Biogen's pipeline includes therapies for spinal muscular atrophy (SMA) and synuclein-targeting Parkinson's, providing multiple opportunities through 2027 [3]. - The company has a strong balance sheet with $10 billion in cash and $6 billion in debt, allowing for significant R&D investment, buybacks, or M&A activities [3]. Technical Analysis - The stock has shown resilience, bouncing off a support level of $125 and currently trading just below the 100-day SMA of $129 [3]. - Resistance levels are identified between $132 and $136, with the stock positioned for a potential post-earnings movement [3]. Investment Scenarios - Potential upside for the stock is projected between $138 and $145 if earnings exceed expectations, while downside risk is noted between $118 and $122 if multiple sclerosis sales underperform [4]. - A suggested entry point for investors is around $128 to $130, with strategies to scale into strength above $132 or to add on pullbacks [4].

Core Viewpoint - NKGen Biotech has initiated the administration of troculeucel, an autologous NK cell therapy, to a patient with mild-stage Alzheimer's disease under a compassionate use IND authorization from the FDA, marking a significant step in expanding treatment options for patients who do not respond to existing therapies [1][2]. Company Overview - NKGen Biotech is a clinical-stage biotechnology company focused on developing and commercializing innovative autologous and allogeneic NK cell therapeutics, headquartered in Santa Ana, California [4]. - Troculeucel, the company's novel cell-based immunotherapeutic drug candidate, is being developed for neurodegenerative disorders and various cancers, with its International Nonproprietary Name (INN) approved by the WHO [5]. Clinical Development - The ongoing double-blind randomized Phase 2a trial by NKGen is primarily focused on moderate-stage Alzheimer's disease, while the recent IND authorization allows exploration in mild-stage Alzheimer's, particularly for patients unresponsive to first-line therapies [2]. - Clinical experience with troculeucel indicates it is well-tolerated and capable of crossing the blood-brain barrier, improving levels of amyloid, α-synuclein, and tau proteins in cerebrospinal fluid, and reducing neuroinflammation [3]. Industry Context - Currently, there are two FDA-approved amyloid-targeting therapies for Alzheimer's patients with mild cognitive impairment, which slow cognitive decline but do not halt disease progression or improve cognitive function [3]. - The exploration of troculeucel in patients progressing on standard therapies could provide insights into disease mechanisms and support combination treatment strategies [3].

Core Points - The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has reaffirmed its positive opinion for the anti-Aβ monoclonal antibody lecanemab, which was initially adopted in November 2024, allowing the European Commission (EC) to resume its decision-making process for marketing authorization [1][2] - Lecanemab is currently under regulatory review in 18 countries and regions, with approvals already granted in multiple countries including the U.S., Japan, and China [7] - The approval of lecanemab would address the significant unmet need for new treatment options for Alzheimer's disease, which currently affects an estimated 15.2 million people with mild cognitive impairment and 6.9 million with Alzheimer's dementia in Europe [3] Company Collaboration - Eisai serves as the lead for lecanemab's development and regulatory submissions globally, with Biogen co-commercializing and co-promoting the product [5][9] - The collaboration between Eisai and Biogen for Alzheimer's disease treatments has been ongoing since 2014, with Eisai holding final decision-making authority [9] - Eisai has a long-term collaboration with BioArctic for the development and commercialization of Alzheimer's treatments, having obtained global rights for lecanemab in December 2007 [10][11] Clinical Studies - The Phase 3 clinical study AHEAD 3-45 for individuals with preclinical Alzheimer's disease is ongoing, funded by the National Institute on Aging, Eisai, and Biogen [8] - The Tau NexGen clinical study for Dominantly Inherited Alzheimer's Disease (DIAD) is also ongoing and includes lecanemab as the backbone anti-amyloid therapy [8]