Tharimmune Stock Surges Over 200% on Opioid Countermeasure Data
Positive FDA feedback and promising 24-hour protection data for its fentanyl overdose prophylactic, TH104, fuel the rally.
Shares of Tharimmune, Inc. (Nasdaq: THAR) skyrocketed on Wednesday, posting a stunning 206% rally during regular trading hours and adding another 42% in after-hours activity. The surge followed the company's announcement of positive simulation results for its lead drug candidate, TH104, a potential countermeasure to fentanyl exposure, and favorable guidance from the U.S. Food and Drug Administration.
The clinical-stage biotechnology company reported that pharmacokinetic (PK) simulation data showed TH104 could provide sustained protection against respiratory depression caused by high-potency opioids for approximately 24 hours after a single dose. This represents a significant potential advantage over existing naloxone injection products, which typically offer a protection window of only 30 to 90 minutes. TH104 is a non-injectable buccal film formulation of nalmefene, designed for rapid absorption and ease of use, particularly for military personnel and first responders in high-risk environments.
Fueling investor optimism, Tharimmune also revealed it had received positive feedback from the FDA, which indicated that no additional clinical trials seem necessary before the company submits a 505(b)(2) New Drug Application (NDA). This streamlined regulatory path could significantly accelerate the timeline and reduce costs for bringing TH104 to market as a critical tool for national security.
Randy Milby, CEO of Tharimmune, stated, "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 company has secured global patents for the drug's delivery technology extending to at least 2040, bolstering its long-term commercial prospects. While the recent data is from simulations, it provides a strong scientific basis for the drug's potential efficacy as Tharimmune moves toward a pivotal NDA submission.