Ensysce BiosciencesNASDAQ: ENSC

Phase 3 Study to Assess PF614 Efficacy in Treating Post-Surgical Pain SAN DIEGO, CA / ACCESSWIRE / September 19, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced it has submitted to the FDA its PF614-301 protocol of the study, "A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty". Included in the Phase 3 study is the Company's statistical analysis plan for review and input by the FDA.

~ PF614 and PF614-MPAR Highlighted at Symposium on Severe Pain ~ SAN DIEGO, CA / ACCESSWIRE / September 13, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, has made available two video segments from its August 8th symposium at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain in Amsterdam, Netherlands. The Company's symposium emphasized opioid use worldwide, the current landscape for treating severe pain, including post-surgical and cancer pain treatment, and discussed Ensysce's innovative new class of opioid drug products.

SAN DIEGO, CA / ACCESSWIRE / August 29, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced that it has entered into definitive agreements, providing the Company with aggregate gross proceeds of $5 million, for the issuance and sale of an aggregate of 3,553,194 of its shares of common stock (or common stock equivalents in lieu thereof) at a purchase price of $0.47 per share (or common stock equivalent in lieu thereof) in a registered direct offering. The Company also entered into definitive agreements to exercise certain outstanding warrants to purchase up to an aggregate of 7,203,504 shares of common stock of the Company originally issued in February 2024, having an exercise price of $1.06 per share, at a reduced exercise price of $0.47 per share.

Next Clinical Trial of FDA Breakthrough Therapy PF614-MPAR Supported by $14 Million Federal Government Grant SAN DIEGO, CA / ACCESSWIRE / August 27, 2024 / Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ:ENSC), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced that it has received Investigational Review Board ("IRB") approval of the PF614-MPAR-102 protocol, ‘A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co‑Administered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects.' Ensysce has continued its collaboration with Quotient Sciences to conduct this second clinical study of MPAR using their Translational Pharmaceutics® platform.

NEW YORK, Aug. 23, 2024 (GLOBE NEWSWIRE) -- Diamond Equity Research, a leading equity research firm with a focus on small capitalization public companies has released an Update Note on Ensysce Biosciences, Inc. (NASDAQ: ENSC). The update note includes information on Ensysce Biosciences' business model, services, industry, financial results, valuation, and risks.

~ PF614 and PF614-MPAR Discussed in Satellite Symposium on Severe Pain ~ SAN DIEGO, CA / ACCESSWIRE / August 8, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, provides a summary of its successful symposium at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain in Amsterdam, Netherlands. The Company's symposium illustrated the current landscape of severe pain, including post-surgical and cancer pain treatment, and discussed potential innovative treatment options, noting the limited number of new therapeutic agents approved in the last ten years.

~ Ready to Commence PF614 Phase 3 Clinical Trial in 2024 ~ ~ Continued Clinical Development of Overdose Protection Breakthrough Therapy ~ ~ Identified Lead Clinical Candidate for Opioid Use Disorder Program ~ SAN DIEGO, CA / ACCESSWIRE / July 23, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today provides a Company review and update on a successful first half of 2024, including achievement of Breakthrough Therapy designation from the U.S. Food & Drug Administration (FDA). Recent clinical and development highlights: PF614: Successfully completed a PF614 End of Phase 2 meeting with the FDA, which provided guidance on strategy and design of the Phase 3 clinical program.

~ Dr. Lynn Kirkpatrick, CEO, to Introduce Satellite Symposium on Severe Pain: A New Chapter for Safer Analgesics ~ SAN DIEGO, CA / ACCESSWIRE / July 9, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today announced that the Company will host a symposium at the International Association for the Study of Pain (IASP) 2024 World Congress on Pain on August 8, 2024 in Amsterdam, Netherlands. The Symposium entitled: ‘Severe Pain: A New Chapter for Safer Analgesics' will feature Dr. Lars Arendt-Nielsen, Professor of Aalberg University of Medicine, Denmark, and Dr. William Schmidt, Chief Medical Officer of Ensysce Biosciences, two leading authorities on pain, pain treatment and analgesic drug development.

~ Selects Lead Candidate with Abuse Deterrence and Improved Safety Profile to Treat Opioid Use Disorder ~ SAN DIEGO, CA / ACCESSWIRE / June 6, 2024 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing the potential for opioid misuse, abuse and overdose, today announced the achievement of a critical milestone in its opioid use disorder (OUD) program with the selection of a lead drug candidate to move into Investigational New Drug (IND) enabling studies. Designed with the application of Ensysce's TAAP platform to reduce the abuse profile, lead candidate PF9001 has shown lower potential for cardiovascular side effects associated with traditional methadone opioid use disorder (OUD) treatments.