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 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.
Ensysce Biosciences (NASDAQ:ENSC), a clinical-stage pharmaceutical company focused on developing pain relief solutions with reduced opioid abuse potential, has announced a $1.1 million registered direct offering priced at-the-market under Nasdaq rules. The company will issue 315,188 shares of common stock at $3.49 per share.
In a concurrent private placement, Ensysce will issue Series A-5 and A-6 warrants, each to purchase up to 315,188 shares at an exercise price of $3.24 per share. The A-5 warrants have an 18-month term, while A-6 warrants extend for 5 years. H.C. Wainwright & Co. serves as the exclusive placement agent.
The net proceeds will support the continued development of Ensysce's TAAP and MPAR programs and provide working capital. The offering is expected to close around March 31, 2025.
Ensysce Biosciences (NASDAQ:ENSC) has announced its upcoming symposium at PAINWeek 2025 on September 3, 2025, focusing on pain management perspectives. The company recently hosted a panel discussion titled 'The State of the Nation in Pain: A Discussion on Analgesics and Their Optimal Uses'.
The panel, moderated by Ensysce's CMO Dr. William Schmidt, included pain medicine experts Dr. Todd Bertoch and Dr. Jeff Gudin. They discussed various analgesics, treatment effectiveness, and advances in pain medicine, including Ensysce's next-generation opioid PF614.
A key finding from the discussion revealed that while new analgesic classes are needed, opioids remain the gold standard for severe pain treatment. The company's development of 'Next Generation' opioids with safety features, including overdose protection through products like PF614 and PF614-MPAR, could potentially offer significant societal benefits.
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