Ensysce Biosciences, Inc.
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- Ensysce Biosciences, Inc. (NASDAQ:ENSC) is a clinical-stage pharmaceutical company that develops abuse-deterrent and overdose-resistant prodrug technologies for severe pain relief while reducing the potential for opioid misuse, abuse, and overdose. The company leverages its proprietary Trypsin Activated Abuse Protection (TAAP) platform, which creates tamper-proof oral prodrugs activated only in the small intestine to prevent abuse via snorting, extraction, injection, or chewing; and its Multi-Pill Abuse Resistant (MPAR) platform, which adds overdose protection by inhibiting activation when multiple pills are ingested, combining TAAP prodrugs with a trypsin inhibitor such as nafamostat. Lead product candidates include PF614, a TAAP-based extended-release oxycodone prodrug for moderate-to-severe chronic pain with FDA Fast Track and Breakthrough Therapy designations; PF614-MPAR, an enhanced version providing both abuse and overdose resistance; and nafamostat, under development for infection and pulmonary diseases beyond its overdose protection role. Ensysce operates in the biotechnology sector, targeting patients with high unmet needs in pain management, oncology, and related areas, with universal application potential across oral prescription drugs prone to abuse. Originally incorporated in Delaware in 2003 as PharmacoFore, Inc., renamed Signature Therapeutics in 2012, and rebranded Ensysce Biosciences following a 2021 business combination, the company maintains headquarters at 7946 Ivanhoe Avenue, Suite 201, La Jolla, California 92037. Recent developments include initiation of the pivotal Phase 3 PF614-301 trial in July 2025 for post-abdominoplasty pain; positive FDA feedback on Phase 3 design with enrollment planned for 2Q2025; a $14 million multi-year non-dilutive NIH/NIDA grant in 2024 to support PF614-MPAR studies and NDA preparation; an August 2024 $5 million financing; a November 2025 $4 million convertible preferred stock financing with up to $16 million more available; a key manufacturing and commercialization partnership with Purisys LLC (a Noramco subsidiary); engagement of Rho, Inc. for trial management; and plans for PF614 NDA submission in 2026 followed by potential commercialization.
Company News
Ensysce Biosciences Phase 2 Protocol for CY200 - A Neuroplastigen for the Treatment of CRPS - Submitted to the UK MHRA
Ensysce Biosciences Advances CRPS Program at Painweek 2026, Contributes to FDA Hearing on Psychedelic Drug Regulation
Ensysce Biosciences' Professor Richard Langford Selected to Speak at FDA Public Hearing on the Potential Future Therapeutic Use of Psychedelic Drugs
Ensysce Biosciences Announces Upcoming Conference and Industry Event Participation
Ensysce Biosciences Completes Final Phase of PF614-MPAR-102 Clinical Study
Ensysce Biosciences to Showcase "A New Era in Pain Therapeutics" at PAINWeek 2026 Symposium
Ensysce Biosciences, Inc. (ENSC) Discusses Acquisition of Cy Biopharma and Private Placement Financing Prepared Remarks Transcript
Ensysce Biosciences Reports Second Quarter 2026 Financial Results and Recent Business Highlights
Ensysce Biosciences (NASDAQ:ENSC) versus CannAmerica Brands (OTCMKTS:CNNXF) Head to Head Review
Ensysce Biosciences Announces Acquisition of Cy Biopharma and up to $77 Million Private Financing
Ensysce Biosciences Awarded $5.3 Million Installment in NIDA Funding Completing Multi-Year $15 Million Federal Grant
Ensysce Biosciences Enrolls First Patient in Final Phase of PF614-MPAR-102 Clinical Study
Ensysce Biosciences Reports First Quarter 2026 Financial Results
Ensysce Biosciences Announces Expansion of Patent Protection for Groundbreaking MPAR(R) Overdose Protection Technology
Ensysce Biosciences CEO Presents at Inaugural Clinical Pain Symposium in Amsterdam
Ensysce Biosciences Secures IRB Approval of Final Phase of PF614-MPAR-102 Clinical Study
Ensysce Biosciences Secures Second Financing From 2025 Agreement to Advance Breakthrough Pain Programs
Ensysce Biosciences Reports Fourth Quarter and Full Year 2025 Financial Results
Ensysce Biosciences, Inc. (NASDAQ:ENSC) Short Interest Down 59.3% in March
Ensysce Biosciences Initiates Live "Ask Me Anything" (AMA) Session Highlighting Growth and Future Plans