Tharimmune, Inc. (NASDAQ:THAR) saw its stock climb 11% on Thursday after the company said U.S. regulators offered constructive feedback on the development pathway for TH104, its nalmefene buccal-film candidate designed to prevent respiratory depression caused by fentanyl and other high-potency opioids.
The company reported that the FDA agreed with its proposed simulation modeling strategy for TH104 during a formal Type D meeting and also provided technical recommendations to guide the next phase of modeling work. Tharimmune said the agency’s support lowers regulatory risk around the program, which is moving forward under the 505(b)(2) New Drug Application route, a pathway often used to streamline approvals.
Early pharmacokinetic simulations for TH104 have shown a rapid onset of action—reaching protective levels in about 30 minutes—and a protection window of roughly 24 hours, the company said. That duration is significantly longer than the 30–90 minutes typically offered by naloxone, suggesting TH104 could serve as a longer-acting countermeasure in environments where repeated dosing is impractical.
Tharimmune also noted that work is underway on its Chemistry, Manufacturing and Controls (CMC) plan, aimed at scaling up production of the buccal film. The company emphasized that the non-injectable format may be especially useful for first responders operating in hazardous conditions where protective gear makes injections difficult.
In previous correspondence, the FDA told the company that no additional clinical trials appear necessary ahead of the NDA submission, potentially accelerating the regulatory timeline for a product primarily aimed at military personnel and emergency teams that may confront opioid-related threats.
Alongside its clinical activities, Tharimmune — which labels itself as both a clinical-stage biotech and digital asset treasury firm — recently outlined plans to build a digital asset treasury strategy using Canton Coin to support market digitization within the Canton Network.