By Robb M. Stewart

Tharimmune's shares were under pressure Thursday despite the company's lead clinical asset receiving what it said was positive feedback from the Food and Drug Administration on a simulation modeling plan.

In premarket trading, the shares were down 6% after climbing sharply earlier in the morning. The stock has climbed almost 60% this year, last closing at $3.22.

Tharimmune said the FDA following a review concurred with its proposed modeling plan for its TH104 nalmefene buccal film opioid treatment, and provided guidance on specific technical elements that the company plans to integrate into the finalized modeling.

It said the FDA's feedback further de-risks the TH104 program.

Tharimmune said it presented its initial pharmacokinetic simulation results and a plan for a more detailed pharmacokinetic modeling for FDA review. The modeling plan represents a critical component in advancing TH104 as a prophylactic countermeasure to mitigate respiratory depression caused by fentanyl and other ultrapotent opioids.

Additionally, the company said it is on track to initiate a comprehensive chemistry, manufacturing, and controls plan, focusing on scaling production and ensuring the quality and consistency of the TH104 buccal film product for advanced clinical development and commercial readiness.

Write to Robb M. Stewart at robb.stewart@wsj.com

(END) Dow Jones Newswires

November 13, 2025 09:23 ET (14:23 GMT)

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