NEW YORK, July 24, 2024 – 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 the U.S.

2024年7月24日，纽约——Tiziana Life Sciences，Ltd.（纳斯达克：TLSA）（“Tiziana”或“公司”），一家生物技术公司，开发突破性的免疫调节疗法，其主要开发候选药物鼻内foralumab是一种全人抗CD3单克隆抗体，今天宣布美国。

Food and Drug Administration (FDA) has granted Fast Track designation for its intranasal formulation of foralumab, a fully human anti-CD3 monoclonal antibody, for the treatment of non-active Secondary Progressive Multiple Sclerosis (na-SPMS).The Fast Track designation is a significant milestone for Tiziana Life Sciences, providing an expedited review process and increased interaction with the FDA.

。快速通道指定是Tiziana Life Sciences的一个重要里程碑，提供了一个快速的审查过程，并增加了与FDA的互动。

This designation is intended to facilitate the development of and expedite the review of drugs that treat serious conditions and fill an unmet medical need.  Only four Fast Track designations have been granted in 2024 by FDA’s Center for Drug Evaluation and Research as of March 31, 2024.“We are thrilled to receive Fast Track designation from the FDA for intranasal foralumab for the treatment of Multiple Sclerosis,” said Gabriele Cerrone, Chairman, acting CEO and founder of Tiziana Life Sciences.

该名称旨在促进治疗严重疾病并满足未满足医疗需求的药物的开发和加速审查。。

“This designation underscores the potential of foralumab to address critical unmet needs in the treatment of neurodegenerative diseases. We are committed to advancing this promising therapy as quickly as possible to benefit patients.”The Fast Track designation provides several benefits, including more frequent meetings with the FDA to discuss the drug’s development plan, eligibility for Accelerated Approval and Priority Review if relevant criteria are met, and a potential Rolling Review of the New Drug Application (NDA).“Receiving Fast Track designation is a testament to the innovative ap.

“这一指定强调了福鲁单抗在治疗神经退行性疾病方面解决关键未满足需求的潜力。我们致力于尽快推进这一有希望的治疗方法，使患者受益。”快速通道指定提供了几个好处，包括更频繁地与FDA会面，讨论药物的开发计划，如果符合相关标准，有资格加速批准和优先审查，以及对新药申请（NDA）进行潜在的滚动审查。。