Tharimmune announces positive fda feedback on nda path for th104 for prophylaxis of respiratory and/or cns depression for ultrapotent opioid exposure

-received positive feedback on new drug application submission via the 505(b)(2) pathway -company leveraging existing human pharmacokinetic data with th104 -advancing cmc plan to meet requirements of a new drug application bridgewater, nj / access newswire / march 31, 2025 / tharimmune, inc. (nasdaq:thar) ("tharimmune" or the "company"), a clinical-stage biotechnology company focused on immunology and inflammation, today announced in addition to developing th104 for the proposed indication of moderate-to-severe chronic pruritus in patients with primary biliary cholangitis ("pbc"), which utilizes an approved active ingredient, now formulated as a buccal film, tharimmune is seeking to develop th104 for the additional proposed indication of "temporary prophylaxis of respiratory and/or nervous system depression in military personnel and chemical incident responders entering an area contaminated with high-potency opioids", for which we have submitted a pre-investigational new drug application ("pind"). with respect to our pind for this additional proposed indication for th104, tharimmune recently received positive feedback from the u.s. food and drug administration (fda) regarding a regulatory pathway that will allow the company to submit a 505(b)(2) new drug application (nda) for th104.
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