Ensysce Biosciences shares rise 21.88% premarket after initiating pivotal Phase 3 trial of PF614 for post-surgical pain.

Ensysce Biosciences surged 21.88% in premarket trading following the announcement that the first patient was enrolled in its pivotal Phase 3 trial of PF614, a next-generation opioid with built-in abuse protection. The trial, PF614-301, aims to evaluate the drug’s efficacy and safety for moderate to severe post-surgical pain while addressing abuse risks through an innovative chemical mechanism. The enrollment marks a critical step toward potential regulatory approval and commercialization, with the study designed to demonstrate consistent pain relief via twice-daily dosing. The news aligns with the company’s strategy to redefine opioid therapy safety, as highlighted by CEO Dr. Lynn Kirkpatrick, and underscores investor optimism about PF614’s market potential. Earlier updates, including FDA feedback and financing milestones, provided context but the Phase 3 trial initiation directly drove the premarket rally.