Tharimmune received FDA approval of its pharmacokinetic simulation modeling plan for the TH104 buccal‑film nalmefene product, confirming that no additional clinical trials are required before filing a 505(b)(2) New Drug Application for the drug’s intended use as a prophylactic countermeasure against respiratory depression from high‑potency opioids.
The approval follows a formal Type D meeting in which the company presented its initial simulation results and detailed modeling plan. The FDA’s positive feedback removes a major development hurdle and aligns with Tharimmune’s strategy to advance a national‑security‑focused therapeutic that can be self‑administered by military personnel and first responders.
The announcement was well received by investors, reflecting confidence in the regulatory clarity and the accelerated development timeline for TH104.
By de‑risking the program, the company can potentially file its 505(b)(2) NDA earlier than anticipated, positioning TH104 in a niche market with limited competition and supporting a broader pivot from chronic pruritus to a critical countermeasure for opioid exposure.
CEO Randy Milby described the FDA feedback as a “significant milestone” that underscores the company’s progress toward commercial readiness and highlights the buccal‑film formulation’s advantage for rapid, self‑administered protection.
In addition to its clinical pipeline, Tharimmune is pursuing a digital asset treasury strategy, acquiring Canton Coin and raising approximately $540 million through a private placement to support this diversification.
With the regulatory milestone in place, TH104 is positioned for an earlier NDA submission, and the company’s dual focus on biotechnology and digital assets reflects a strategic effort to broaden its growth prospects while addressing a pressing national‑security concern.
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