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BRIDGEWATER, NEW JERSEY - Tharimmune Inc. (NASDAQ:THAR), a clinical-stage biopharmaceutical company currently valued at $2.53 million, has received positive feedback from the U.S. Food and Drug Administration (FDA) for its drug candidate TH104, a buccal film designed for rapid absorption to potentially prevent respiratory and nervous system depression caused by exposure to high-potency opioids. According to InvestingPro data, the company maintains a healthy balance sheet with more cash than debt, despite its stock trading near $1.20, significantly below its 52-week high of $6.45. This feedback suggests that no further clinical trials may be needed before submitting a New Drug Application under the 505(b)(2) regulatory pathway.
The development of TH104 is in response to increasing concerns about national security threats posed by weaponized opioids, such as fentanyl and its analogues. The U.S. Strategic National Stockpile (SNS) market assessment has highlighted the urgent need for medical countermeasures against such threats. TH104 is positioned as a promising solution for military personnel and chemical incident responders who may encounter these dangerous substances.
The Department of Defense (DoD) and the Administration for Strategic Preparedness and Response (ASPR), part of the Department of Health and Human Services (HHS), have underscored the importance of having prophylactic measures ready for use in the field. TH104’s buccal film delivery system could offer a significant advantage over current naloxone formulations, particularly in operational environments requiring full protective gear.
Randy Milby, CEO of Tharimmune, emphasized the importance of the FDA’s positive response, stating it marks a crucial step forward in countering the potential weaponization of fentanyl and its derivatives. The company’s focus is to ensure that TH104 becomes available to those at the front lines, providing a significant advantage in protecting against the immediate effects of opioid exposure. While InvestingPro analysis shows the company maintains a current ratio of 1.54, indicating adequate short-term liquidity, investors should note that analysts do not expect profitability this year.
Tharimmune’s commitment to addressing chemical threats aligns with the U.S. government’s focus on preparedness. The company’s broader portfolio includes therapeutic candidates targeting immunology, inflammation, oncology, and other indications for TH104, such as chronic pruritus in primary biliary cholangitis. Additionally, Tharimmune is developing TH023 for autoimmune diseases and a multispecific biologic platform for solid tumors through its proprietary EpiClick™ Technology.
The information in this article is based on a press release statement from Tharimmune Inc. It should be noted that forward-looking statements in the press release are not guarantees of future performance and are subject to various risks and uncertainties. InvestingPro analysis reveals an analyst price target of $5.00, though the company’s overall Financial Health Score remains weak at 1.35. Subscribers to InvestingPro can access 6 additional ProTips and comprehensive financial metrics to better evaluate the investment potential of THAR and similar biotech opportunities.
In other recent news, Tharimmune, Inc. has received positive feedback from the U.S. Food and Drug Administration (FDA) for its regulatory submission strategy concerning TH104. The FDA has allowed Tharimmune to proceed with a New Drug Application for TH104 through the 505(b)(2) pathway without additional clinical trials. Additionally, Tharimmune unveiled HS1940, a new cancer treatment candidate that targets both PD-1 and VEGF receptors, and plans to advance preclinical testing. In organizational developments, Tharimmune announced the retirement of two board members, Leonard Mazur and Dr. Lynne Bui, at the 2025 Annual Meeting of Stockholders. The company also faced a Nasdaq non-compliance notice due to falling below the stockholders’ equity requirement, prompting it to explore compliance options. Meanwhile, Tharimmune appointed Don Kim as the new Chief Financial Officer following Thomas Hess’s resignation. These developments reflect the company’s ongoing efforts to maintain its strategic direction and compliance while expanding its product pipeline.
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