Tiziana requests orphan drug designation for foralumab

If granted, the designation could provide seven years of market exclusivity upon approval and other regulatory benefits.

Rhea-AI Filing Summary

Tiziana Life Sciences Ltd (TLSA) submitted a request to the U.S. Food and Drug Administration for Orphan Drug Designation for intranasal foralumab to treat multiple system atrophy (MSA). The FDA grants the designation to drugs or biologics intended for rare diseases or conditions affecting fewer than 200,000 people in the United States. MSA currently has no FDA-approved disease-modifying therapies.

Tiziana is also evaluating intranasal foralumab in a Phase 2a open-label trial for MSA.

Filing Explained

The filing describes a pending request, not an FDA award; if granted, the designation could provide seven years of market exclusivity after approval, and the FDA aims to review requests within 90 days of receipt.

Key Figures

Orphan Drug Designation review target: within 90 days Rare-disease population threshold: fewer than 200,000 people Potential market exclusivity: seven years +5 more

8 metrics

Orphan Drug Designation review target within 90 days The FDA's Office of Orphan Products Development aims to complete review after receipt.

Rare-disease population threshold fewer than 200,000 people United States; eligibility for Orphan Drug Designation.

Potential market exclusivity seven years Upon approval, if the designation is granted.

Mean U.S. MSA incidence approximately 0.6 per 100,000 person-years Mean incidence in the United States.

MSA incidence among people aged 50 and older about 3 per 100,000 Incidence in people aged 50 and older.

Worldwide MSA prevalence roughly 1.9–4.9 per 100,000 Worldwide prevalence estimates.

MSA trial duration six months Phase 2a open-label study.

Foralumab dosing cycles eight 3-week dosing cycles Intranasal administration in the MSA trial.

Key Terms

Orphan Drug Designation, Multiple System Atrophy, microglial activation, anti-CD3 monoclonal antibody

4 terms

Orphan Drug Designation regulatory

"request to the FDA for Orphan Drug Designation"

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

Multiple System Atrophy medical

"for the Treatment of Multiple System Atrophy (MSA)"

A progressive neurological disorder that damages multiple areas of the nervous system, causing problems with movement, balance and involuntary functions like blood pressure and bladder control; think of it as critical wiring in the body slowly failing. Investors care because the condition defines the size and urgency of the market for treatments, influences clinical trial difficulty and regulatory risk, and can lead to high per-patient pricing but also greater development uncertainty.

microglial activation medical

"assess effects on microglial activation (via PET imaging)"

Microglial activation is when the brain’s resident immune cells — microglia — switch from a resting, maintenance role into an alert, defensive state, similar to a neighborhood cleanup crew suddenly racing to douse a small fire. For investors, this matters because persistent or excessive activation is a hallmark of many neurological diseases, affects how drugs perform in trials, and can drive regulatory and market reactions to therapies aimed at calming or harnessing this response.

anti-CD3 monoclonal antibody medical

"a fully human, anti-CD3 monoclonal antibody"

A lab-made antibody engineered to attach to CD3, a protein found on T cells, so it can change how those immune cells behave. Investors care because these drugs can act like a targeted brake on an overactive immune system—useful for autoimmune disease, transplant rejection or as part of cancer therapies—but they also carry clinical trial, safety and regulatory risks that determine commercial success.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What benefits could orphan drug designation provide for TLSA's foralumab?

If the FDA grants the designation, potential benefits include seven years of market exclusivity upon approval, tax credits for qualified clinical testing, waiver of certain FDA application fees, and eligibility for protocol assistance.

How is TLSA testing foralumab in its MSA trial?

The six-month Phase 2a open-label study is being conducted within the MyTrial Program at Brigham and Women's Hospital in Boston. Foralumab is given as a nasal spray across eight 3-week dosing cycles; the study assesses microglial activation through PET imaging, clinical outcomes, and safety.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 09/30/2026 - 07:00 AM Accepted by SEC EDGAR 09/30/2026 - 07:00 AM Learn about SEC filing dates

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

September 2026

Commission File Number:  001-38723

Tiziana Life Sciences LTD

(Exact Name of Registrant as Specified in Its Charter)

9^th Floor

107 Cheapside

London

EC2V 6DN

(Address of registrant’s principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F ☒        Form 40-F ☐

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

On September 30, 2026, Tiziana Life Sciences LTD (the “Company”) issued this 6K announcing, that it has submitted a request to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for intranasal foralumab for the treatment of Multiple System Atrophy (MSA).

The Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibits 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as otherwise set forth herein or as shall be expressly set forth by specific reference in such a filing.

1

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

	TIZIANA LIFE SCIENCES LTD
Date: September 30, 2026	By:	/s/ Keeren Shah
		Name:	Keeren Shah
		Title:	Chief Financial Officer

2

EXHIBIT INDEX

Exhibit No.		Description
99.1		Tiziana Life Sciences LTD Press Release, dated September 30, 2026

3

Exhibit 99.1

 

Tiziana Life Sciences Files for Orphan Drug Designation with the FDA for Intranasal Foralumab for the Treatment of Multiple System Atrophy (MSA)

BOSTON, MA, September 30, 2026 – 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, today announced that it has submitted a request to the U.S. Food and Drug Administration (FDA) for Orphan Drug Designation for intranasal foralumab for the treatment of Multiple System Atrophy (MSA).

MSA is a rare, rapidly progressive neurodegenerative disorder that affects autonomic functions (such as blood pressure and bladder control) and motor control, leading to severe disability and shortened life expectancy. There are currently no FDA-approved disease-modifying therapies for MSA. The disease has a mean incidence in the U.S. of approximately 0.6 per 100,000 person-years, rising to about 3 per 100,000 in those aged 50 and older, with prevalence estimates of roughly 1.9–4.9 per 100,000 worldwide. Median survival is typically 6–9 years. Neuroinflammation and microglial activation are increasingly recognized as key contributors to MSA pathogenesis.

Orphan Drug Designation is granted by the FDA to drugs or biologics intended to treat rare diseases or conditions affecting fewer than 200,000 people in the United States. The FDA’s Office of Orphan Products Development (OOPD) aims to complete its review of an orphan drug designation (ODD) request within 90 days of receipt. If granted, the designation would provide potential benefits including seven years of market exclusivity upon approval, tax credits for qualified clinical testing, waiver of certain FDA application fees, and eligibility for protocol assistance.

Tiziana is currently evaluating intranasal foralumab in a Phase 2a open-label clinical trial (ClinicalTrials.gov Identifier: NCT06868628) in patients with MSA. The six-month study is designed to assess effects on microglial activation (via PET imaging), clinical outcomes, and safety. Foralumab is administered via nasal spray across eight 3-week dosing cycles. The Phase 2a trial is being conducted within the MyTrial Program at Brigham and Women’s Hospital in Boston under the leadership of Principal Investigator Vikram Khurana, MD, PhD, Tracy T. Batchelor Endowed Chair and Division Chief of Movement Disorders at Mass General Brigham.

Dr Khurana commented: “Multiple system atrophy remains one of the most challenging neurodegenerative diseases we face, with rapid progression and no approved therapies that alter its course. The growing recognition of neuroinflammation and microglial activation as central drivers of MSA pathology makes intranasal foralumab a particularly compelling candidate. By harnessing the immune system’s regulatory pathways in a targeted, non-systemic way, this approach has the potential to address a critical unmet need. The ongoing clinical study, which includes PET imaging of microglial activity, will provide important early insights into whether this strategy can meaningfully impact the disease process.”

Ivor Elrifi, Chief Executive Officer of Tiziana Life Sciences, commented: “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. Foralumab administered intranasally induces regulatory T cells and modulates T-cell-driven inflammation. Its ability to reduce microglial activation offers a promising strategy to slow neuronal damage in neuroinflammatory and neurodegenerative conditions including MSA. This non-systemic approach is designed to promote immune tolerance while minimizing systemic immune suppression.”

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 14 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program (NCT06802328) with either an improvement or stability of disease seen within 6 months in all patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923), as well as additional Phase 2 trials in AD and MSA.

Intranasal foralumab is the only fully human anti-CD3 monoclonal antibody (mAb) currently in clinical development. Immunomodulation by intranasal foralumab represents a novel avenue for the treatment of neuroinflammatory and neurodegenerative human diseases.^[1],[2]

About Tiziana Life Sciences

Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. Tiziana’s innovative intranasal approach has the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb currently in clinical development, has demonstrated a favorable safety profile and clinical response in patients in studies to date. Tiziana’s technology for alternative routes of immunotherapy has been patented with several applications pending and is expected to allow for broad pipeline applications.

For more information about Tiziana Life Sciences and its innovative pipeline of therapies, please visit www.tizianalifesciences.com.

Forward-Looking Statements

Statements in this press release may be “forward-looking statements” within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, and Section 21E of the U.S. Securities Exchange Act of 1934, as amended, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These forward-looking statements reflect the current beliefs and expectations of Tiziana’s management and include statements regarding the closing of the Offering. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Tiziana’s Annual Report on Form 20-F for the year ended December 31, 2025, and other periodic reports filed with the SEC from time to time. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.

For further inquiries:

Tiziana Life Sciences Ltd

Paul Spencer, Business Development, and Investor Relations
+44 (0) 207 495 2379
email: info@tizianalifesciences.com

[1] https://www.pnas.org/doi/10.1073/pnas.2220272120

[2] https://www.pnas.org/doi/10.1073/pnas.2309221120

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 TIZIANA LIFE SCIENCES LTD PRESS RELEASE, DATED SEPTEMBER 30, 2026 16.2 KB