Business
Ensysce Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results
~ Fourth Quarter Highlighted by Clinical and Regulatory Milestones Positioning PF614 for Late-Stage Advancement ~ SAN DIEGO, CA / ACCESS Newswire / March 30,
About this update from Ensysce Biosciences, Inc.
[{"type":"text","content":"~ Fourth Quarter Highlighted by Clinical and Regulatory Milestones Positioning PF614 for Late-Stage Advancement ~ SAN DIEGO, CA / ACCESS Newswire / March 30, 2026 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) (\"Ensysce\" or the \"Company\"), a clinical-stage pharmaceutical company developing innovative solutions for novel therapeutics while reducing the potential for abuse and overdose, today reported financial and operational results for the fourth quarter and full year ended December 31, 2025.\"2025 was a year of meaningful progress for Ensysce, marked by significant clinical advancement, productive regulatory engagement, and continued strengthening of our intellectual property portfolio,\" said Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce Biosciences. \"We initiated our Phase 3 trial for PF614 and had constructive dialogue with the FDA supporting our manufacturing pathway.\"Dr. Kirkpatrick continued, \"Enrollment in the PF614-301 Phase 3 study has progressed rapidly, while PF614-MPAR remains on an accelerated development path under Breakthrough Therapy designation. In parallel, we have advanced commercial manufacturing readiness for PF614 and have generated additional data supporting overdose-protection labeling for our MPAR platform. Beyond our late-stage programs, we strengthened the long-term value of our technology platforms through expanded patent protection and pipeline growth, including the advancement of PF9001 for opioid use disorder (OUD) and leveraging our TAAP™ and MPAR® technologies for additional indications such as attention deficit hyperactivity disorder (ADHD).\"Program UpdatesTAAPTM (Opioid Abuse Deterrent) Program UpdateEnsysce's lead drug candidate, PF614, is a Trypsin-Activated Abuse Protection (TAAPTM) extended-release oxycodone designed to deliver effective pain relief while incorporating built-in abuse protection. Through proprietary chemical modification of oxycodone, PF614 remains pharmacologically inactive until swallowed and exposed to trypsin in the small intestine, where it is activated to release oxycodone. This mechanism is designed to preserve therapeutic efficacy while significantly reducing the potential for tampering and abuse.In December 2025, Ensysce announced the enrollment of the first patient in its pivotal Phase 3 clinical trial (PF614-301) evaluating PF614 for the treatment ...