Tharimmune Soars 22.06% on FDA NDA Approval for TH104

On April 1, 2025, Tharimmune's stock price surged by 22.06% in pre-market trading, reflecting significant investor optimism and market confidence in the company's recent developments.

Tharimmune has received positive feedback from the FDA regarding the submission of a New Drug Application (NDA) for TH104 through the 505(b)(2) pathway. This pathway allows the company to leverage existing human pharmacokinetic data, avoiding the need for additional clinical trials. The FDA's approval is a major milestone for Tharimmune, as it expedites the development and potential availability of TH104 for the treatment of moderate-to-severe chronic pruritus in patients with primary biliary cholangitis (PBC).

In addition to its work on TH104 for PBC, Tharimmune is also exploring the use of TH104 for the prophylaxis of respiratory and/or CNS depression in military personnel and chemical incident responders exposed to high-potency opioids. The company has submitted a Pre-Investigational New Drug Application (PIND) for this additional indication and received positive feedback from the FDA, which confirms that no additional clinical trials will be required prior to NDA submission for this indication.

Tharimmune is also advancing its Chemistry, Manufacturing, and Controls (CMC) plan to meet the stringent requirements for filing an NDA with the FDA. This comprehensive plan ensures the consistent production of a high-quality buccal film formulation known as TH104. The company's forward-looking statements indicate a strong commitment to its development pipeline, which includes TH023, an oral TNF-alpha inhibitor, and early-stage multispecific biologics targeting multiple solid tumors through its proprietary EpiClick Technology.