Tharimmune, Inc. shares surge over 100% after announcing results from pharmacokinetic simulation analysis of TH104, trading at $2.27

Tharimmune, Inc. shares surge over 100% after announcing results from pharmacokinetic simulation analysis of TH104, trading at $2.27

Tharimmune, Inc. (THAR) saw its shares surge over 100% on July 2, 2025, following the announcement of positive pharmacokinetic simulation results for TH104, its buccal film formulation of nalmefene. The company's stock traded at $2.27, reflecting investor optimism about the potential of TH104 as a prophylactic treatment against fentanyl-induced respiratory depression.

The simulation analysis revealed that TH104 achieves protective effects within 30 minutes post-dose and maintains protection for approximately 24 hours, potentially offering superior duration compared to existing treatments like naloxone. The non-injectable buccal delivery system provides rapid absorption and convenient administration for first responders and military personnel.

The FDA has indicated that no additional clinical trials appear necessary before a 505(b)(2) New Drug Application (NDA) submission, streamlining the path to potential approval. This accelerated pathway could substantially reduce time-to-market and development costs.

Tharimmune's TH104 shows promising 24-hour protection against fentanyl-induced respiratory depression, potentially outperforming short-acting naloxone. The pharmacokinetic simulations indicate TH104 reaches protective concentrations within 30 minutes post-administration and maintains this protection for approximately 24 hours, representing a significant improvement over naloxone injections, which typically provide protection for only 30-90 minutes.

The prolonged prophylactic window of TH104 could be crucial in high-risk environments where exposure is a constant threat and immediate access to medical personnel may be limited. The buccal film delivery of TH104 is designed as a non-injectable, rapid absorption and convenient-to-use administration, which may be advantageous for first responders who may be wearing full protective gear.

The recent positive feedback from the U.S. Food and Drug Administration (FDA) confirms that no additional clinical trials appear necessary prior to a 505(b)(2) New Drug Application (NDA) submission, providing a path forward for Tharimmune to advance TH104.

References:
[1] https://www.tradingview.com/news/tradingview:ac31c8ef9a0d8:0-tharimmune-inc-sec-10-q-report/
[2] https://stockanalysis.com/markets/gainers/
[3] https://www.stocktitan.net/news/THAR/tharimmune-reports-pharmacokinetic-simulation-results-for-th104-as-mr9yaebvjjfd.html