Welcome to our dedicated page for Ensysce Biosciences news (Ticker: ENSC), a resource for investors and traders seeking the latest updates and insights on Ensysce Biosciences stock.
Ensysce Biosciences Inc (NASDAQ: ENSC) is a clinical-stage pharmaceutical innovator developing safer opioid therapies through its patented TAAP and MPAR technologies. This dedicated news hub provides investors and healthcare professionals with essential updates on the company's progress in addressing prescription drug abuse.
Access real-time information about clinical trial milestones, regulatory submissions, and strategic partnerships. Our curated collection features press releases covering product development breakthroughs, intellectual property updates, and operational developments in pain management solutions.
Key content includes updates on abuse-deterrent formulation testing, FDA communication statuses, manufacturing collaborations, and financial performance reports. All materials maintain strict compliance with financial disclosure regulations while emphasizing patient safety advancements.
Bookmark this page for streamlined tracking of ENSC's mission to transform opioid therapy through biochemical innovation and rigorous clinical validation. Check regularly for verified updates directly from corporate communications and authorized news sources.
Ensysce Biosciences (NASDAQ:ENSC) has launched its pivotal Phase 3 study of PF614, a next-generation opioid designed for severe pain management with built-in abuse and overdose protection. The study, designated PF614-301, will evaluate the drug's efficacy and safety in treating moderate to severe pain following abdominoplasty.
The company has partnered with Rho, Inc., a clinical research organization with extensive CNS and pain study expertise, having managed over 90 neurology trials across 840 sites in the past five years. The study aims to demonstrate PF614's ability to provide effective post-surgical pain relief while offering a safer alternative to conventional opioids.
Ensysce Biosciences (NASDAQ:ENSC) has announced full enrollment of Part 2 in their PF614-MPAR-102 clinical study, focusing on evaluating food effects on their MPAR overdose protection technology. The study is supported by a three-year NIDA grant extending through May 2027.
PF614-MPAR, which has received FDA Breakthrough Therapy designation, combines Ensysce's proprietary TAAP™ and MPAR® technologies to provide pain relief with built-in overdose protection. The technology is designed to maintain therapeutic efficacy while preventing overdose when doses exceed prescribed amounts.
Ensysce Biosciences (NASDAQ:ENSC) has appointed Tracy Hysong, CCRA as Senior Director of Regulatory Affairs. Hysong, a Certified Clinical Research Associate, brings extensive regulatory experience from UC Davis, where she helped establish the Clinical Trials Office. This strategic hire comes as Ensysce prepares for multiple clinical milestones:
- Initiating Phase 3 pivotal study for PF614 with planned NDA submission in 2026 - Ongoing clinical studies for overdose-protected pain medicine PF614-MPAR - Preparing IND Application and Phase 1 study for novel PF9001 opioid use disorder (OUD) treatment
The appointment strengthens Ensysce's regulatory capabilities as it manages three current INDs and prepares for a fourth IND submission for its OUD treatment.
Ensysce Biosciences (NASDAQ:ENSC) has announced the closing of warrant exercises generating $2.2 million in gross proceeds. The transaction involved the exercise of warrants to purchase 630,376 shares at $3.24 per share, originally issued in March 2025.
In exchange for the warrant exercise and an additional $0.125 per new warrant, the company issued new unregistered warrants for up to 1,260,752 shares at an exercise price of $1.90. Half of these new warrants have an 18-month term, while the remainder have a 5-year term.
The net proceeds will support the continued development of TAAP™ and MPAR® programs and working capital. H.C. Wainwright & Co. served as the exclusive placement agent for the offering.
Ensysce Biosciences (NASDAQ:ENSC) has announced the exercise of warrants that will generate approximately $2.2 million in gross proceeds. The agreement involves the immediate exercise of warrants to purchase 630,376 shares of common stock at $3.24 per share, originally issued in March 2025.
In exchange for the immediate exercise, the company will issue new unregistered warrants for up to 1,260,752 shares at an exercise price of $1.90 per share. Half of these new warrants will have an 18-month term, while the other half will have a 5-year term. H.C. Wainwright & Co. is serving as the exclusive placement agent.
The offering is expected to close around April 24, 2025. The company plans to use the net proceeds to continue development of its TAAP™ and MPAR® programs and for working capital.
Ensysce Biosciences (NASDAQ:ENSC) has received a U.S. Patent Notice of Allowance for PF9001, a novel treatment for opioid use disorder (OUD). The patent covers both composition of matter and method of use claims for enzyme-cleavable methadone prodrugs.
The innovative medication utilizes Ensysce's TAAP and MPAR technologies for abuse deterrence and overdose protection. PF9001 represents an advancement over traditional methadone treatment, showing reduced potential for cardiotoxicity and offering overdose protection. The drug demonstrates promise for once-daily dosing with prolonged and predictable effects.
The research, supported by the National Institute on Drug Abuse under Award Number UG3DA050271, aims to address limitations of current OUD treatments, particularly concerns over cardiac side effects, respiratory depression, and overdose risks.
Ensysce Biosciences (NASDAQ:ENSC) has announced positive results from Part 1 of its second clinical trial evaluating PF614-MPAR for opioid overdose protection. The study demonstrated that their combined TAAP and MPAR technologies can effectively deliver pain relief while protecting against overdose risks.
The trial confirmed that a 100 mg dosage of PF614-MPAR successfully delivers oxycodone for severe pain treatment while providing overdose protection at higher-than-prescribed doses. When subjects took three or more doses simultaneously, the maximum oxycodone release (Cmax) was reduced compared to unprotected PF614, with greater protection observed at five doses. No unexpected adverse events were reported.
The study will proceed with Part 2 to examine food effects and Part 3 to evaluate repeat dosing. PF614-MPAR is currently the only opioid product with FDA's Breakthrough Therapy designation. The company plans to discuss the complete analysis with the FDA regarding full development plans for commercialization.
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