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BRIDGEWATER, NJ - Tharimmune, Inc. (NASDAQ:THAR), a biotechnology company specializing in immunology and inflammation with a current market capitalization of approximately $3 million, has received positive feedback from the U.S. Food and Drug Administration (FDA) regarding its regulatory submission strategy for TH104, the company announced today. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet, which could support its development initiatives. The FDA has confirmed that Tharimmune can submit a New Drug Application (NDA) for TH104 through the 505(b)(2) pathway without requiring additional clinical trials.
TH104, which is currently under development, is formulated as a buccal film and is intended for two indications. The first is for the treatment of moderate-to-severe chronic pruritus in patients with primary biliary cholangitis (PBC). The second, newly proposed indication is for the temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders exposed to high-potency opioids.
The FDA’s positive response is a significant milestone for Tharimmune, as it allows the company to leverage existing pharmacokinetic data and the established safety and efficacy profile of the active ingredient, nalmefene, to expedite the drug’s development. Nalmefene has been used in approved products for opioid overdose, and Tharimmune is now planning an "in silico" submission, which uses computer simulations to predict drug behavior based on existing human studies and published data.
In addition to the regulatory progress, Tharimmune is advancing its Chemistry, Manufacturing, and Controls (CMC) plan to meet the FDA’s rigorous standards for filing an NDA. This plan includes all aspects of manufacturing, quality control, and product stability to ensure the consistent production of TH104. While the company’s financial health score from InvestingPro indicates some challenges, with analysts forecasting a loss for the current fiscal year, the company’s solid cash position could provide runway for its development programs.
Tharimmune’s portfolio also includes other therapeutic candidates in immunology, inflammation, and oncology, such as TH023, an oral TNF-alpha inhibitor, and early-stage multispecific biologics targeting solid tumors through its EpiClick™ Technology.
The company’s recent developments and future plans will be detailed in the investor relations section of their website in upcoming filings. The information in this article is based on a press release statement. Despite the stock’s significant decline of about 78% over the past year, analysts maintain a $5 price target, suggesting potential upside from current levels. InvestingPro subscribers have access to 8 additional key insights about Tharimmune’s financial health and market performance.
In other recent news, Tharimmune, Inc. has announced the development of a new cancer treatment, HS1940, which utilizes a dual-action mechanism targeting both PD-1 and VEGF receptors. This innovative therapeutic candidate, supported by Tharimmune’s proprietary EpiClick Technology, aims to improve patient outcomes by engaging multiple epitopes and inhibiting tumor growth. The company plans to advance preclinical testing and begin IND-enabling studies in 2025. Additionally, Tharimmune is working on multispecific antibodies targeting HER2 and HER3, further expanding its pipeline of cancer therapies. In another development, Tharimmune has appointed Don Kim as the new Chief Financial Officer following the resignation of Thomas Hess. Kim, who brings extensive financial expertise from his previous roles at UroGen Pharma Ltd. and other companies, began his tenure on March 27, 2025. The transition in leadership is part of Tharimmune’s ongoing efforts to strengthen its financial operations while advancing its pharmaceutical portfolio.
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