{"success":true,"data":{"pressRelease":{"id":"156456","rtpr_id":"nGNX6Vxk8m-20260930","ticker":"TLSA","exchange":"NASDAQ","all_tickers":["TLSA"],"title":"Tiziana Life Sciences Files for Orphan Drug Designation with the FDA for Intranasal Foralumab for the Treatment of Multiple System Atrophy (MSA)","author":"Globe Newswire","published_at":"2026-09-30T11:00:00.693Z","article_body":"BOSTON, Sept. 30, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd.\n(Nasdaq: TLSA\n(https://www.globenewswire.com/Tracker?data=cLqOI9dfyeGmMcBKaMo3oibbpLqCTVae47Kzk4PgOUFpLMW0-TKuCcNzCE32DtabGdAeJ6DopYO9wwK0YEfsWvj_2EUx9mZHF0ekTrcvZzxkE4ySDNKZh9Nz1fhJs-vL))\n(“Tiziana” or the “Company”), a biotechnology company developing\nbreakthrough immunomodulation therapies with its lead development candidate,\nintranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today\nannounced that it has submitted a request to the U.S. Food and Drug\nAdministration (FDA) for Orphan Drug Designation for intranasal foralumab for\nthe treatment of Multiple System Atrophy (MSA).\n\nMSA is a rare, rapidly progressive neurodegenerative disorder that affects\nautonomic functions (such as blood pressure and bladder control) and motor\ncontrol, leading to severe disability and shortened life expectancy. There are\ncurrently no FDA-approved disease-modifying therapies for MSA. The disease has\na mean incidence in the U.S. of approximately 0.6 per 100,000 person-years,\nrising to about 3 per 100,000 in those aged 50 and older, with prevalence\nestimates of roughly 1.9–4.9 per 100,000 worldwide. Median survival is\ntypically 6–9 years. Neuroinflammation and microglial activation are\nincreasingly recognized as key contributors to MSA pathogenesis.\n\nOrphan Drug Designation is granted by the FDA to drugs or biologics intended\nto treat rare diseases or conditions affecting fewer than 200,000 people in\nthe United States. The FDA’s Office of Orphan Products Development (OOPD)\naims to complete its review of an orphan drug designation (ODD) request within\n90 days of receipt. If granted, the designation would provide potential\nbenefits including seven years of market exclusivity upon approval, tax\ncredits for qualified clinical testing, waiver of certain FDA application\nfees, and eligibility for protocol assistance.\n\nTiziana is currently evaluating intranasal foralumab in a Phase 2a open-label\nclinical trial (ClinicalTrials.gov Identifier: NCT06868628\n(https://www.globenewswire.com/Tracker?data=1VQLEj9QV-TyWqffly_wcXBdONxUIdzgwsW-IfhxzTpqV8K__X8Otw0sFw2LjzmDrTgGdhyh3kjQU-5MH38tGV8LWoUCasEcrL9wAf4A4FU4kQ2om9yTwsxy0CXIu1R7))\nin patients with MSA. The six-month study is designed to assess effects on\nmicroglial activation (via PET imaging), clinical outcomes, and safety.\nForalumab is administered via nasal spray across eight 3-week dosing cycles.\nThe Phase 2a trial is being conducted within the MyTrial Program at Brigham\nand Women’s Hospital in Boston under the leadership of Principal\nInvestigator Vikram Khurana, MD, PhD, Tracy T. Batchelor Endowed Chair and\nDivision Chief of Movement Disorders at Mass General Brigham.\n\nDr Khurana commented: “Multiple system atrophy remains one of the most\nchallenging neurodegenerative diseases we face, with rapid progression and no\napproved therapies that alter its course. The growing recognition of\nneuroinflammation and microglial activation as central drivers of MSA\npathology makes intranasal foralumab a particularly compelling candidate. By\nharnessing the immune system’s regulatory pathways in a targeted,\nnon-systemic way, this approach has the potential to address a critical unmet\nneed. The ongoing clinical study, which includes PET imaging of microglial\nactivity, will provide important early insights into whether this strategy can\nmeaningfully impact the disease process.”\n\nIvor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented:\n“Filing for Orphan Drug Designation for intranasal foralumab in MSA\nrepresents an important regulatory step as we advance this novel therapy for\npatients facing a devastating disease with no approved disease-modifying\noptions. Foralumab administered intranasally induces regulatory T cells and\nmodulates T-cell-driven inflammation. Its ability to reduce microglial\nactivation offers a promising strategy to slow neuronal damage in\nneuroinflammatory and neurodegenerative conditions including MSA. This\nnon-systemic approach is designed to promote immune tolerance while minimizing\nsystemic immune suppression.”\n\nAbout Foralumab\nForalumab, a fully human anti-CD3 monoclonal antibody, is a biological drug\ncandidate that has been shown to stimulate T regulatory cells when dosed\nintranasally. At present, 14 patients with Non-Active Secondary Progressive\nMultiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate\nsized Expanded Access (EA) Program (NCT06802328\n(https://www.globenewswire.com/Tracker?data=1VQLEj9QV-TyWqffly_wcVgtn6ZI2k7BWmqEr4hfy0PWjc1HIQjkiH4awvtTp1Z9ddoTYrZOn2LbuEIdh02zkEFM4afff27W57pwUTCkFidbJMiHXH6NrXghlSXpoTyi))\nwith either an improvement or stability of disease seen within 6 months in all\npatients. In addition, intranasal foralumab is currently being studied in a\nPhase 2a, randomized, double-blind, placebo-controlled, multicenter,\ndose-ranging trial in patients with non-active secondary progressive multiple\nsclerosis (NCT06292923\n(https://www.globenewswire.com/Tracker?data=1VQLEj9QV-TyWqffly_wcR8Fnzhni0FvdX9wjf4Y0RquT1i6inIBcJBjSEWeXITThz8-emoRbPXQWUhYR7_L5XOAuHq5_BMf-ofNNYOw9i7Xt1h0TF_hhAI9HC5bASOX)),\nas well as additional Phase 2 trials in AD and MSA.\n\nIntranasal foralumab is the only fully human anti-CD3 monoclonal antibody\n(mAb) currently in clinical development. Immunomodulation by intranasal\nforalumab represents a novel avenue for the treatment of neuroinflammatory and\nneurodegenerative human diseases.([1],[2])\n\nAbout Tiziana Life Sciences\n\nTiziana Life Sciences is a clinical-stage biopharmaceutical company developing\nbreakthrough therapies using transformational drug delivery technologies to\nenable alternative routes of immunotherapy. Tiziana’s innovative intranasal\napproach has the potential to provide an improvement in efficacy as well as\nsafety and tolerability compared to intravenous (IV) delivery. Tiziana’s\nlead candidate, intranasal foralumab, which is the only fully human anti-CD3\nmAb currently in clinical development, has demonstrated a favorable safety\nprofile and clinical response in patients in studies to date. Tiziana’s\ntechnology for alternative routes of immunotherapy has been patented with\nseveral applications pending and is expected to allow for broad pipeline\napplications.\n\nFor more information about Tiziana Life Sciences and its innovative pipeline\nof therapies, please visit www.tizianalifesciences.com.\n\nForward-Looking Statements\n\nStatements in this press release may be “forward-looking statements”\nwithin the meaning of Section 27A of the U.S. Securities Act of 1933, as\namended, and Section 21E of the U.S. Securities Exchange Act of 1934, as\namended, that concern matters that involve risks and uncertainties that could\ncause actual results to differ materially from those anticipated or projected\nin the forward-looking statements. These forward-looking statements are not\nhistorical facts but rather are based on the Company’s current expectations,\nestimates, and projections about its industry; its beliefs; and assumptions.\nWords such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’\n‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are\nintended to identify forward-looking statements. These forward-looking\nstatements reflect the current beliefs and expectations of Tiziana’s\nmanagement and include statements regarding the closing of the Offering. These\nstatements are not guarantees of future performance and are subject to known\nand unknown risks, uncertainties, and other factors, some of which are beyond\nthe Company’s control, are difficult to predict, and could cause actual\nresults to differ materially from those expressed or forecasted in the\nforward-looking statements. The Company cautions security holders and\nprospective security holders not to place undue reliance on these\nforward-looking statements, which reflect the view of the Company only as of\nthe date of this announcement. Actual results may differ materially from those\nindicated by such forward-looking statements as a result of various important\nfactors, including: the uncertainties related to market conditions and other\nfactors described more fully in the section entitled ‘Risk Factors’ in\nTiziana’s Annual Report on Form 20-F for the year ended December 31, 2025,\nand other periodic reports filed with the SEC from time to time. The\nforward-looking statements made in this announcement relate only to events as\nof the date on which the statements are made. The Company will not undertake\nany obligation to release publicly any revisions or updates to these\nforward-looking statements to reflect events, circumstances, or unanticipated\nevents occurring after the date of this announcement except as required by law\nor by any appropriate regulatory authority.\n\nFor further inquiries:\n\nTiziana Life Sciences Ltd\nPaul Spencer, Business Development, and Investor Relations\n+44 (0) 207 495 2379\nemail: info@tizianalifesciences.com\n\n[1] https://www.pnas.org/doi/10.1073/pnas.2220272120\n[2] https://www.pnas.org/doi/10.1073/pnas.2309221120\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/991c340c-a083-4bcb-ad41-e7eea83f6f97)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX6Vxk8m-20260930","title":"Tiziana Life Sciences Files for Orphan Drug Designation with the FDA for Intranasal Foralumab for the Treatment of Multiple System Atrophy (MSA)","author":"Globe Newswire","ticker":"TLSA","created":"2026-09-30T11:00:00.693Z","tickers":["TLSA"],"exchange":"NASDAQ","article_body":"BOSTON, Sept. 30, 2026 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd.\n(Nasdaq: TLSA\n(https://www.globenewswire.com/Tracker?data=cLqOI9dfyeGmMcBKaMo3oibbpLqCTVae47Kzk4PgOUFpLMW0-TKuCcNzCE32DtabGdAeJ6DopYO9wwK0YEfsWvj_2EUx9mZHF0ekTrcvZzxkE4ySDNKZh9Nz1fhJs-vL))\n(“Tiziana” or the “Company”), a biotechnology company developing\nbreakthrough immunomodulation therapies with its lead development candidate,\nintranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today\nannounced that it has submitted a request to the U.S. Food and Drug\nAdministration (FDA) for Orphan Drug Designation for intranasal foralumab for\nthe treatment of Multiple System Atrophy (MSA).\n\nMSA is a rare, rapidly progressive neurodegenerative disorder that affects\nautonomic functions (such as blood pressure and bladder control) and motor\ncontrol, leading to severe disability and shortened life expectancy. There are\ncurrently no FDA-approved disease-modifying therapies for MSA. The disease has\na mean incidence in the U.S. of approximately 0.6 per 100,000 person-years,\nrising to about 3 per 100,000 in those aged 50 and older, with prevalence\nestimates of roughly 1.9–4.9 per 100,000 worldwide. Median survival is\ntypically 6–9 years. Neuroinflammation and microglial activation are\nincreasingly recognized as key contributors to MSA pathogenesis.\n\nOrphan Drug Designation is granted by the FDA to drugs or biologics intended\nto treat rare diseases or conditions affecting fewer than 200,000 people in\nthe United States. The FDA’s Office of Orphan Products Development (OOPD)\naims to complete its review of an orphan drug designation (ODD) request within\n90 days of receipt. If granted, the designation would provide potential\nbenefits including seven years of market exclusivity upon approval, tax\ncredits for qualified clinical testing, waiver of certain FDA application\nfees, and eligibility for protocol assistance.\n\nTiziana is currently evaluating intranasal foralumab in a Phase 2a open-label\nclinical trial (ClinicalTrials.gov Identifier: NCT06868628\n(https://www.globenewswire.com/Tracker?data=1VQLEj9QV-TyWqffly_wcXBdONxUIdzgwsW-IfhxzTpqV8K__X8Otw0sFw2LjzmDrTgGdhyh3kjQU-5MH38tGV8LWoUCasEcrL9wAf4A4FU4kQ2om9yTwsxy0CXIu1R7))\nin patients with MSA. The six-month study is designed to assess effects on\nmicroglial activation (via PET imaging), clinical outcomes, and safety.\nForalumab is administered via nasal spray across eight 3-week dosing cycles.\nThe Phase 2a trial is being conducted within the MyTrial Program at Brigham\nand Women’s Hospital in Boston under the leadership of Principal\nInvestigator Vikram Khurana, MD, PhD, Tracy T. Batchelor Endowed Chair and\nDivision Chief of Movement Disorders at Mass General Brigham.\n\nDr Khurana commented: “Multiple system atrophy remains one of the most\nchallenging neurodegenerative diseases we face, with rapid progression and no\napproved therapies that alter its course. The growing recognition of\nneuroinflammation and microglial activation as central drivers of MSA\npathology makes intranasal foralumab a particularly compelling candidate. By\nharnessing the immune system’s regulatory pathways in a targeted,\nnon-systemic way, this approach has the potential to address a critical unmet\nneed. The ongoing clinical study, which includes PET imaging of microglial\nactivity, will provide important early insights into whether this strategy can\nmeaningfully impact the disease process.”\n\nIvor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented:\n“Filing for Orphan Drug Designation for intranasal foralumab in MSA\nrepresents an important regulatory step as we advance this novel therapy for\npatients facing a devastating disease with no approved disease-modifying\noptions. Foralumab administered intranasally induces regulatory T cells and\nmodulates T-cell-driven inflammation. Its ability to reduce microglial\nactivation offers a promising strategy to slow neuronal damage in\nneuroinflammatory and neurodegenerative conditions including MSA. This\nnon-systemic approach is designed to promote immune tolerance while minimizing\nsystemic immune suppression.”\n\nAbout Foralumab\nForalumab, a fully human anti-CD3 monoclonal antibody, is a biological drug\ncandidate that has been shown to stimulate T regulatory cells when dosed\nintranasally. At present, 14 patients with Non-Active Secondary Progressive\nMultiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate\nsized Expanded Access (EA) Program (NCT06802328\n(https://www.globenewswire.com/Tracker?data=1VQLEj9QV-TyWqffly_wcVgtn6ZI2k7BWmqEr4hfy0PWjc1HIQjkiH4awvtTp1Z9ddoTYrZOn2LbuEIdh02zkEFM4afff27W57pwUTCkFidbJMiHXH6NrXghlSXpoTyi))\nwith either an improvement or stability of disease seen within 6 months in all\npatients. In addition, intranasal foralumab is currently being studied in a\nPhase 2a, randomized, double-blind, placebo-controlled, multicenter,\ndose-ranging trial in patients with non-active secondary progressive multiple\nsclerosis (NCT06292923\n(https://www.globenewswire.com/Tracker?data=1VQLEj9QV-TyWqffly_wcR8Fnzhni0FvdX9wjf4Y0RquT1i6inIBcJBjSEWeXITThz8-emoRbPXQWUhYR7_L5XOAuHq5_BMf-ofNNYOw9i7Xt1h0TF_hhAI9HC5bASOX)),\nas well as additional Phase 2 trials in AD and MSA.\n\nIntranasal foralumab is the only fully human anti-CD3 monoclonal antibody\n(mAb) currently in clinical development. Immunomodulation by intranasal\nforalumab represents a novel avenue for the treatment of neuroinflammatory and\nneurodegenerative human diseases.([1],[2])\n\nAbout Tiziana Life Sciences\n\nTiziana Life Sciences is a clinical-stage biopharmaceutical company developing\nbreakthrough therapies using transformational drug delivery technologies to\nenable alternative routes of immunotherapy. Tiziana’s innovative intranasal\napproach has the potential to provide an improvement in efficacy as well as\nsafety and tolerability compared to intravenous (IV) delivery. Tiziana’s\nlead candidate, intranasal foralumab, which is the only fully human anti-CD3\nmAb currently in clinical development, has demonstrated a favorable safety\nprofile and clinical response in patients in studies to date. Tiziana’s\ntechnology for alternative routes of immunotherapy has been patented with\nseveral applications pending and is expected to allow for broad pipeline\napplications.\n\nFor more information about Tiziana Life Sciences and its innovative pipeline\nof therapies, please visit www.tizianalifesciences.com.\n\nForward-Looking Statements\n\nStatements in this press release may be “forward-looking statements”\nwithin the meaning of Section 27A of the U.S. Securities Act of 1933, as\namended, and Section 21E of the U.S. Securities Exchange Act of 1934, as\namended, that concern matters that involve risks and uncertainties that could\ncause actual results to differ materially from those anticipated or projected\nin the forward-looking statements. These forward-looking statements are not\nhistorical facts but rather are based on the Company’s current expectations,\nestimates, and projections about its industry; its beliefs; and assumptions.\nWords such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’\n‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are\nintended to identify forward-looking statements. These forward-looking\nstatements reflect the current beliefs and expectations of Tiziana’s\nmanagement and include statements regarding the closing of the Offering. These\nstatements are not guarantees of future performance and are subject to known\nand unknown risks, uncertainties, and other factors, some of which are beyond\nthe Company’s control, are difficult to predict, and could cause actual\nresults to differ materially from those expressed or forecasted in the\nforward-looking statements. The Company cautions security holders and\nprospective security holders not to place undue reliance on these\nforward-looking statements, which reflect the view of the Company only as of\nthe date of this announcement. Actual results may differ materially from those\nindicated by such forward-looking statements as a result of various important\nfactors, including: the uncertainties related to market conditions and other\nfactors described more fully in the section entitled ‘Risk Factors’ in\nTiziana’s Annual Report on Form 20-F for the year ended December 31, 2025,\nand other periodic reports filed with the SEC from time to time. The\nforward-looking statements made in this announcement relate only to events as\nof the date on which the statements are made. The Company will not undertake\nany obligation to release publicly any revisions or updates to these\nforward-looking statements to reflect events, circumstances, or unanticipated\nevents occurring after the date of this announcement except as required by law\nor by any appropriate regulatory authority.\n\nFor further inquiries:\n\nTiziana Life Sciences Ltd\nPaul Spencer, Business Development, and Investor Relations\n+44 (0) 207 495 2379\nemail: info@tizianalifesciences.com\n\n[1] https://www.pnas.org/doi/10.1073/pnas.2220272120\n[2] https://www.pnas.org/doi/10.1073/pnas.2309221120\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/991c340c-a083-4bcb-ad41-e7eea83f6f97)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-09-30T11:00:01.619772586Z","server_sent_at_ms":1790766001619},"received_at":"2026-09-30T11:00:01.669Z","source_url":null},"analysis":{"id":"145147","press_release_id":"156456","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":["ODD request is only a filing, not a grant; FDA decision pending and not guaranteed"],"eventType":"regulatory","narrative":"Tiziana Life Sciences has submitted a request to the FDA for Orphan Drug Designation for intranasal foralumab in Multiple System Atrophy, a rare neurodegenerative disease with no approved disease-modifying therapies.\n\nIf granted, the designation would provide seven years of market exclusivity upon approval, tax credits for clinical testing, and fee waivers; the FDA aims to complete its review within 90 days.\n\nForalumab is currently in a Phase 2a open-label trial in MSA patients at Brigham and Women's Hospital led by Dr. Vikram Khurana, and in Phase 2 trials in non-active secondary progressive multiple sclerosis.","sentiment":"bullish","agentHooks":{"shouldPost":false,"suggestedAngle":"Early-stage pipeline news: ODD filing for foralumab in MSA with a 90-day FDA review window to watch."},"keyFigures":{"drugName":"intranasal foralumab (anti-CD3 monoclonal antibody)","phaseOfTrial":"Phase 2a","customDimensions":{"median_survival_years":"6-9","odd_review_timeline_days":90,"msa_incidence_us_per_100k":0.6,"market_exclusivity_years_if_granted":7}},"quotedText":"Filing for Orphan Drug Designation for intranasal foralumab in MSA represents an important regulatory step as we advance this novel therapy for patients facing a devastating disease with no approved disease-modifying options.","namedEntities":{"people":[{"name":"Vikram Khurana","role":"Principal Investigator, Division Chief of Movement Disorders at Mass General Brigham"},{"name":"Ivor Elrifi","role":"CEO of Tiziana Life Sciences"},{"name":"Paul Spencer","role":"Business Development and Investor Relations"}],"products":["intranasal foralumab"],"companies":[{"name":"Tiziana Life Sciences, Ltd.","ticker":"TLSA","relationship":"filer"},{"name":"Brigham and Women's Hospital","relationship":"trial site"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"materialImpact":{"score":2,"reasoning":"Filing a request for Orphan Drug Designation is an early regulatory step, not an approval or decision; FDA review takes up to 90 days. Incremental positive pipeline news for a clinical-stage micro-cap, not market-moving."},"tickerRelevance":{"others":[],"primary":"TLSA"},"globalImportance":20,"audienceRelevance":18,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"micro-cap clinical-stage biotech","eventGravity":"regulatory filing (not decision)","sectorWeight":"biotech pipeline news","issuerAuthored":true}},"event_type":"regulatory","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":2,"narrative":"Tiziana Life Sciences has submitted a request to the FDA for Orphan Drug Designation for intranasal foralumab in Multiple System Atrophy, a rare neurodegenerative disease with no approved disease-modifying therapies.\n\nIf granted, the designation would provide seven years of market exclusivity upon approval, tax credits for clinical testing, and fee waivers; the FDA aims to complete its review within 90 days.\n\nForalumab is currently in a Phase 2a open-label trial in MSA patients at Brigham and Women's Hospital led by Dr. Vikram Khurana, and in Phase 2 trials in non-active secondary progressive multiple sclerosis.","key_figures":{"drugName":"intranasal foralumab (anti-CD3 monoclonal antibody)","phaseOfTrial":"Phase 2a","customDimensions":{"median_survival_years":"6-9","odd_review_timeline_days":90,"msa_incidence_us_per_100k":0.6,"market_exclusivity_years_if_granted":7}},"named_entities":{"people":[{"name":"Vikram Khurana","role":"Principal Investigator, Division Chief of Movement Disorders at Mass General Brigham"},{"name":"Ivor Elrifi","role":"CEO of Tiziana Life Sciences"},{"name":"Paul Spencer","role":"Business Development and Investor Relations"}],"products":["intranasal foralumab"],"companies":[{"name":"Tiziana Life Sciences, Ltd.","ticker":"TLSA","relationship":"filer"},{"name":"Brigham and Women's Hospital","relationship":"trial site"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-30T11:00:13.411Z","global_importance":20,"audience_relevance":18,"importance_components":{"tickerTier":"micro-cap clinical-stage biotech","eventGravity":"regulatory filing (not decision)","sectorWeight":"biotech pipeline news","issuerAuthored":true}},"durationMs":6251,"modelName":"glm-5.3-flashx"}}