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 (NASDAQ: ENSC) news coverage tracks this San Diego-based pharmaceutical company's progress developing abuse-deterrent and overdose-resistant opioid medications. As a clinical-stage biotech focused on addressing the opioid crisis through prodrug technology, Ensysce generates news primarily from clinical trial milestones, regulatory interactions, and financing activities.
Follow Ensysce's development of PF614, its lead product candidate incorporating both the TAP Bio-MD abuse-deterrent and MPAR overdose-resistant platforms. News updates cover Phase 3 clinical trial enrollment and results, FDA feedback on regulatory pathways, and manufacturing developments critical to eventual commercialization.
Grant awards from the National Institute on Drug Abuse (NIDA) provide insights into federal recognition of Ensysce's scientific approach. Financial reports reveal cash runway and operational milestones, while conference presentations at pain management symposiums demonstrate industry engagement. Investor communications and SEC filings document strategic decisions and capital structure changes.
Bookmark this page to monitor Ensysce's progression through clinical development and its efforts to bring safer opioid alternatives to market.
Ensysce Biosciences (NASDAQ:ENSC) reported significant progress in Q2 2025 for its innovative opioid therapy programs. The company initiated a pivotal Phase 3 trial for PF614, its lead candidate for severe pain with built-in abuse deterrence. Additionally, Ensysce completed enrollment for Part 2 of the PF614-MPAR-102 study, advancing its overdose protection program.
Key financial highlights include a cash position of $2.2 million as of June 30, 2025, receipt of a $5.3 million NIDA grant installment, and R&D expenses of $1.9 million. The company reported a net loss of $1.7 million for Q2 2025, an improvement from the $2.0 million loss in Q2 2024.
The company's pipeline includes PF614 (TAAP™ technology) and PF614-MPAR (combining TAAP™ and MPAR® technologies), both designed to provide safer opioid therapies. Ensysce also advanced its OUD program with PF9001 as the lead candidate for opioid use disorder treatment.
Ensysce Biosciences (NASDAQ:ENSC) reported positive feedback from the FDA regarding PF614-MPAR, their breakthrough opioid analgesic with built-in overdose protection. The July 23, 2025 FDA meeting focused on achieving overdose protection labeling and confirmed eligibility for a streamlined 505(b)(2) regulatory pathway.
PF614-MPAR, which has received FDA's Breakthrough Therapy designation, utilizes Ensysce's proprietary TAAP™ and MPAR® technologies to maintain pain relief while automatically activating overdose protection if prescribed doses are exceeded. The development is supported by NIDA grants through May 2027.
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.
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