Ensysce Biosciences Inc. (ENSC)
NASDAQ (CM) NASDAQ (CM) Primary 
Ensysce Biosciences Announces IRB Approval for Key MPAR Study
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.
Ensysce Biosciences Receives $14 Million NIH Grant for Clinical Development of Novel Opioid with Overdose Protection
~ Substantial Award Follows FDA Breakthrough Therapy Designation for PF614-MPAR ~ ~ Federal Grant Funding Awarded to Date Now at $40 Million ~ SAN DIEGO, CA / ACCESSWIRE / August 27, 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 receipt of a $14 million multi-year grant from the NIH and National Institute on Drug Abuse (NIDA) for the continued development of PF614-MPAR, an abuse-deterrent opioid with overdose protection that received Breakthrough Therapy designation from the FDA in January 2024. Funding from this award will be available over a period of approximately three years, allowing for the completion of the Phase 1b clinical trial, PF614-MPAR-102.
Ensysce Biosciences Reports Second Quarter 2024 Financial Results
PF614-MPAR Progressing to Phase 1b Study to Verify Both Overdose Protection and Effective Delivery of Oxycodone Opioid Use Disorder Program Advances with Selection of PF9001 as Lead Drug Candidate PF614 Phase 3 Protocol Being Finalized for Submission to FDA SAN DIEGO, CA / ACCESSWIRE / August 14, 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 reported financial and operational results for the second quarter ended June 30, 2024. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Our FDA-designated Breakthrough Therapy product candidate, PF614-MPAR, is a game-changer for Ensysce as we progress to a second clinical trial, PF614-MPAR-102.
Ensysce Biosciences Provides Key Themes Following IASP 2024 Symposium
~ 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.
Ensysce Biosciences Provides Mid-Year 2024 Update
~ 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.
Ensysce Biosciences Hosts IASP 2024 Symposium and Presents Clinical Dataset
~ 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.
Ensysce Biosciences Discusses Key Themes from the EPHMRA 2024 Annual Meeting
~ Geoff Birkett, Chief Commercial Officer, Provides Insight Following EPHMRA Meeting ~ SAN DIEGO, CA / ACCESSWIRE / June 27, 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 takeaways from Geoff Birkett, the Company's Chief Commercial Officer, following his participation on the opening panel of the European Pharmaceutical Market Research Association (EPHMRA) Annual Conference in London on June 25. Geoff Birkett discussed "The Future of Healthcare Research" with industry partners and underlined the importance of new healthcare technologies to address key problems for patients and the companies that serve them.
Ensysce Biosciences Announces Partnership to Scale and Manufacture New Drug Candidate
~ Collaboration with Purisys Positions Ensysce to Expedite Lead OUD Candidate, PF9001, to IND Studies ~ SAN DIEGO, CA / ACCESSWIRE / June 25, 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 an agreement with Purisys LLC ("Purisys") to scale the manufacture of the Company's lead opioid use disorder (OUD) drug candidate. PF9001, as recently announced, is a novel agent developed with Ensysce's unique TAAP technology to treat OUD that will potentially decrease the cardiovascular side effects associated with methadone.
Ensysce Biosciences Announces Major Milestone for Opioid Use Disorder Program
~ 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.
Ensysce Biosciences to Participate in the EPHMRA 2024 Annual Meeting
~ Geoff Birkett, Chief Commercial Officer, Invited to Serve on the Opening Panel at the EPHMRA 2024 Annual Conference ~ SAN DIEGO, CA / ACCESSWIRE / June 3, 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 that Geoff Birkett, the Company's Chief Commercial Officer, has been invited to present at the European Pharmaceutical Market Research Association (EPHMRA) Annual Conference in London on June 24-27, 2024. Geoff Birkett will participate in the EPHMRA opening panel discussion on Tuesday, June 25th titled "The Future of Healthcare Market Research".
