Ensysce Biosciences (ENSC) issued its 2025 annual letter to shareholders from CEO Lynn Kirkpatrick, which read in part, “2025 was a year of meaningful execution and strategic advancement for Ensysce. I would like to thank our shareholders for your continued support as we advance our mission to deliver safer, more responsible opioid analgesics without compromising access to effective pain relief. Over the past year, we made substantial progress across clinical development, regulatory alignment, intellectual property, and financing- strongly positioning the Company for 2026 and beyond. Our efforts in 2025 were centered on advancing our clinical programs built on Ensysce’s proprietary TAAP and MPAR technology platforms. Together, these platforms are designed to fundamentally improve the safety profile of opioid medications by addressing both abuse and overdose risk while preserving therapeutic efficacy…As we enter 2026, Ensysce is positioned for continued momentum. Key anticipated milestones include: Continued enrollment and execution of the PF614-301 Phase 3 trial Advancement of PF614-MPAR under Breakthrough Therapy designation Additional FDA interactions supporting commercial manufacturing readiness Further data generation to support overdose-protection labeling for MPAR products Advancement of PF9001 toward IND-enabling activities We remain committed to advancing the next generation of powerful analgesics that address the severest of pain while incorporating safeguards aligned with modern public health priorities.”
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