Ensysce Biosciences shares surge 12.46% premarket after initiating pivotal Phase 3 trial of PF614 for post-surgical pain.

Ensysce Biosciences (NASDAQ:ENSC) rose 12.46% in premarket trading following the announcement that it has enrolled the first patient in its pivotal Phase 3 trial of PF614, a next-generation opioid with built-in abuse protection. The trial, PF614-301, is a multicenter, randomized, double-blind study evaluating the drug for moderate to severe post-surgical pain after abdominoplasty. This milestone marks a critical step in Ensysce’s path to commercialization and regulatory approval, with the trial designed to demonstrate PF614’s efficacy while addressing abuse and overdose risks through its proprietary chemical mechanism. Enrollment began at key clinical sites in Salt Lake City and Atlanta, led by principal investigators in anesthesiology. The news aligns with the company’s strategy to redefine pain management with safer opioid alternatives, generating optimism among investors about its potential market impact and regulatory progress.