Tharimmune’s TH104 receives positive feedback from FDA

Tharimmune (THAR) announced an update from the biotechnology side of the business. Its lead clinical asset, TH104, received positive feedback from the U.S. FDA on the company’s submitted simulation modeling plan. Tharimmune announced earlier this month its plans to develop a digital asset treasury strategy that leverages the Canton Coin to support the Canton Network’s ability to digitize traditional financial markets. In a formal Type D meeting with the FDA, Tharimmune presented its initial pharmacokinetic simulation results, and the plan for a more detailed pharmacokinetic modeling, for FDA review. This quantitative modeling plan represents a critical component in advancing TH104 as a prophylactic countermeasure to mitigate respiratory depression caused by fentanyl and other ultrapotent opioids. Following its review, the FDA concurred with Tharimmune’s proposed modeling plan and provided constructive guidance on specific technical elements, which the company intends to integrate into the finalized modeling. The FDA’s feedback further de-risks the TH104 program and aligns with Tharimmune’s development strategy for the planned 505(b)(2) New Drug Application submission. In parallel with this regulatory clarity, the company is on track to initiate a comprehensive Chemistry, Manufacturing, and Controls plan. The initiation of this plan represents a key operational milestone, focusing on scaling production and ensuring the quality and consistency of the TH104 buccal film product necessary for advanced clinical development and commercial readiness. The FDA feedback and ongoing CMC planning follow the company’s earlier positive pharmacokinetic simulation analysis for TH104, which further reinforces its potential as a potentially superior prophylactic treatment for military personnel and chemical incident responders who face high-potency opioid exposure.