Ensysce Biosciences Inc Stock Price, News & Analysis

Ensysce Biosciences (NASDAQ:ENSC) hosted a well-attended symposium titled "Pain Management, RE-Invented: A New Era for Analgesia" at PAINWeek 2025 in Las Vegas. The symposium, which drew approximately 400 attendees, featured presentations from leading pain medicine experts highlighting the company's innovative TAAP™ and MPAR® technologies.

The event showcased Ensysce's approach to developing safer opioids, featuring their lead candidate PF614. The technology uniquely uses the body's chemistry to activate pain relief with proper dosing while preventing overdose. Dr. William Schmidt presented data on PF614 and outlined plans for an upcoming Phase 3 trial in acute post-surgical pain.

Ensysce Biosciences (NASDAQ:ENSC) announced that Chief Commercial Officer Geoff Birkett will chair the Fierce New Product Planning Summit 2025, scheduled for September 8-11, 2025, in Philadelphia. Birkett will deliver opening remarks and present a case study on successful product launches.

The summit focuses on helping product planning teams make informed, value-based decisions for commercial success. At Ensysce, Birkett is leading the launch preparations for PF614, the company's first-in-class analgesic designed to combat severe pain while reducing abuse and overdose risks.

Birkett brings extensive experience from leadership roles at Eli Lilly, Lundbeck, and AstraZeneca, where he successfully launched several groundbreaking medicines in pain, addiction, and neuroscience.

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 announced a scientific symposium titled 'Pain Management, RE-Invented: A New Era for Analgesia' to be held at PAINWeek 2025 on September 3rd in Las Vegas. The symposium will feature three prominent experts: Dr. Jeff Gudin from University of Miami Pain Center, Dr. Todd Bertoch from CenExel JBR, and Dr. William Schmidt, Ensysce's CMO. These specialists will discuss current pain therapy challenges and explore Ensysce's innovative TAAP™ and MPAR® technologies, designed to prevent opioid abuse while maintaining effective pain relief. CEO Dr. Lynn Kirkpatrick emphasized the importance of addressing both acute and chronic pain management in the context of changing perspectives on analgesia.

Ensysce Biosciences (NASDAQ:ENSC) has received a $5.3 million grant from NIDA as part of a $15 million, three-year funding commitment to advance PF614-MPAR, their breakthrough opioid therapy. This FDA-designated Breakthrough Therapy combines TAAP and MPAR technologies to provide effective pain relief while incorporating built-in overdose protection. The funding, which began June 1, 2025, will support final drug formulation optimization and clinical evaluation as the company moves toward commercialization. Initial clinical studies have validated the drug's overdose prevention capabilities, and Ensysce plans to engage with the FDA to discuss development plans based on current data.

Ensysce Biosciences (NASDAQ:ENSC) reported Q1 2025 financial results and significant developments in its opioid treatment programs. The company received a U.S. patent for PF9001, their lead opioid use disorder (OUD) drug candidate, adding to their portfolio of over 100 patents. They completed Part 1 of the PF614-MPAR-102 clinical study, demonstrating overdose protection capabilities. Financial highlights include: cash position of $3.1M as of March 31, 2025, federal grant funding of $1.3M (up from $0.3M YoY), and a net loss of $1.9M (improved from $3.1M loss in Q1 2024). R&D expenses increased to $1.9M from $0.8M YoY. The company plans to initiate Phase 3 trials for PF614 in mid-2025 and continues development of their TAAP and MPAR® technologies for safer opioid pain management solutions.