Hepion's GV104 Prevents Fentanyl-Induced Cardiac Arrest in Simulation of 200 Subjects

• Hepion Pharmaceuticals reported GV104 prevented every fentanyl-induced cardiac arrest in a simulation involving 200 virtual subjects.
• A single 16 mg nalmefene buccal film provided simulated protection when taken at least 15 minutes before exposure; untreated arrest risk reached 86.5%.
• The FDA reaffirmed the modeling approach but requested revisions to support demonstrating long-term prophylactic protection.
• The results remain simulation predictions, not clinical outcomes; revised analyses could change the predicted onset, duration and degree of protection.
• Remaining work before a new drug application centers on manufacturing controls, with commercial-scale registration batch production planned to begin in 2027.

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