NEW YORK - Tiziana Life Sciences , Ltd. (NASDAQ:TLSA), a biotechnology firm specializing in immunomodulation therapies, announced today the U.S. Food and Drug Administration (FDA) has approved the expansion of its Expanded Access (EA) program for intranasal foralumab, a treatment for Secondary Progressive Multiple Sclerosis (na-SPMS). The program will now include 30 patients, up from the initial 10.
The EA program facilitates access to foralumab for na-SPMS patients who are not eligible for the company's ongoing Phase 2a trial. To date, two patients have been treated for over a year and eight for six months within the program, reportedly without serious side effects. According to Tiziana, all participants either stabilized or improved in key clinical measures, and 70% experienced a reduction in fatigue.
Foralumab, described as the only fully human anti-CD3 monoclonal antibody, is designed to modulate T cell function and potentially dampen inflammation associated with multiple sclerosis. The intranasal delivery method of foralumab is part of Tiziana's broader strategy to enhance the efficacy and safety of immunotherapies.
The FDA's September 2023 guidance on the use of EA programs suggests that data from these programs may contribute to the body of evidence supporting a drug's efficacy and safety.
Dr. Tanuja Chitnis, Professor of Neurology at Harvard Medical School and senior neurologist at Brigham and Women's Hospital, highlighted the program's role in informing dosing and drug use strategies, emphasizing the importance of patient feedback in shaping the Phase 2a trial design.
This news is based on a press release statement from Tiziana Life Sciences.
InvestingPro Insights
Following Tiziana Life Sciences' announcement of FDA approval for the expansion of its Expanded Access program, investors may be keen on understanding the financial health and market performance of the company. According to InvestingPro data, Tiziana Life Sciences currently holds a market capitalization of 75.59 million USD, reflecting its size within the biotechnology sector. Despite the positive news, the company's Price to Earnings (P/E) ratio remains unavailable, indicating that it has not reported positive net income in the last twelve months as of Q2 2023. The Price/Book ratio stands at 5.71, suggesting that the stock is trading at a premium compared to the company’s book value.
An InvestingPro Tip highlights that Tiziana Life Sciences has more cash than debt on its balance sheet, which could provide some financial flexibility as it continues to develop its treatments. This is a critical factor for investors to consider, especially for a biotech firm that relies on sufficient funding to support its research and development activities. On the performance front, the stock has seen a notable return over the last week, with a 36.89% increase in price total return. This surge could reflect investor optimism following the recent FDA approval news.
Investors interested in a deeper dive into Tiziana Life Sciences' performance metrics and strategic outlook can find additional InvestingPro Tips on the company's page: https://www.investing.com/pro/TLSA. There are currently 11 more tips available, which can provide a more comprehensive analysis of the company's prospects. To access these insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
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