Ensysce Biosciences shares jump 12.77% intraday after PF614 Phase 3 trial enrollment begins and FDA aligns with manufacturing path.

Ensysce Biosciences surged 12.77% intraday after announcing the initiation of its PF614-301 Phase 3 trial for PF614, a trypsin-activated opioid analgesic, at two clinical sites. The FDA aligned with the company’s manufacturing strategy for PF614, enabling commercial-scale production, while a new MPAR® patent extended intellectual property protection through 2042. The firm secured up to $20 million in funding, including a $4 million convertible preferred financing, to advance late-stage programs. These developments—key milestones in regulatory alignment, clinical progress, and financial stability—signaled strong near-term potential for PF614’s market launch and reinforced confidence in Ensysce’s ability to address unmet needs in pain management while mitigating abuse and overdose risks. The intraday rally reflected investor optimism over the company’s strategic advancements and strengthened IP and capital position ahead of 2026 milestones.