Ensysce Biosciences

ENSC

Market cap $6.27M

~ FDA Response Streamlines Path to Commercial Production of PF614~ SAN DIEGO, CA / ACCESS Newswire / November 20, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain and central nervous system therapeutics designed to minimize abuse and overdose risk, today announced that the Food and Drug Administration (FDA or Agency) provided Written Responses to a meeting request. Ensysce had requested guidance on its approach to the manufacture of PF614, wanting to understand the appropriateness of regulatory starting materials (RSMs) and specifications for PF614 drug substance and the RSMs.

~Funding supports Phase 3 clinical development of PF614 and continued innovation in abuse- and overdose-resistant analgesics~ SAN DIEGO, CA / ACCESS Newswire / November 17, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC)("Ensysce" or the "Company"), pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced the closing of a $4 million convertible preferred stock financing, with upside to potentially $16 million of additional funding available through future tranches over the next 24 months. The capital will accelerate the Phase 3 clinical program for PF614, Ensysce's flagship analgesic candidate, while supporting general corporate initiatives.

~ Third Quarter Highlighted by Initiation of Phase 3 Study of PF614, Underscoring Progress Toward Market Readiness and Commitment to Novel Opioid Solutions ~ ~ Further Program Advancement Supported by Preferred Stock Financing ~ SAN DIEGO, CA / ACCESS Newswire / November 14, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation severe pain therapeutics designed to minimize abuse and overdose risk, today reported financial and operational results for the third quarter ended September 30, 2025. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "It has been another highly productive quarter as we navigate tumultuous times in drug development.

~ Pain Management, RE-Invented: Ushering in a New Era for Analgesia ~ SAN DIEGO, CA / ACCESS Newswire / October 10, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering next-generation pain therapeutics designed to minimize abuse and overdose risk, has released video highlights from its widely attended symposium at PAINWeek2025, the world's largest pain management conference. The event, titled "Pain Management, RE-Invented: A New Era for Analgesia," was held in Las Vegas on September 3, 2025, and featured a distinguished panel of medical and scientific leaders.

~ Experts Spotlight TAAP™ and MPAR® as Next-Generation Solutions for Severe Pain ~ SAN DIEGO, CA / ACCESS Newswire / September 4, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage company developing innovative solutions for severe pain relief while reducing the potential for opioid abuse and overdose, today shared key takeaways from its standing-room-only symposium with about 400 attendees, "Pain Management, RE-Invented: A New Era for Analgesia", held September 3, 2025, at PAINWeek in Las Vegas-the world's largest pain management conference. Moderated by Dr. Lynn Kirkpatrick, CEO of Ensysce, the event brought together three leading authorities in pain medicine: Dr. Jessica McCoun, Principal Investigator at CenExel Atlanta, opened with strategies for controlling acute post-operative pain using multi-modal therapy to prevent chronification, the gradual transition from acute pain to chronic pain.

~ The Summit is the Premier Industry Event for Defining How New Product Planning Teams and Related Functions Make Informed, Value-Based, Data-Driven Decisions ~ ~ Ensysce Biopharma Leader to Deliver Opening Remarks and Present Case Study on Launching Successful Brands ~ SAN DIEGO, CA / ACCESS Newswire / August 19, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC), a clinical-stage company pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced that Geoff Birkett, Chief Commercial Officer of Ensysce, will chair the Fierce New Product Planning Summit 2025, held September 8-11, 2025 at the Pennsylvania Convention Center in Philadelphia. Mr. Birkett, recognized for his expertise in product launches and commercial strategy, will deliver the Opening Remarks, set the tone of the meeting, and present a case study on the launch process and how to maximize success.

New York, Aug. 15, 2025 (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 updates, management commentary, financial results, valuation, and risks.

Initiates Critical Milestone, Launching Phase 3 Trial of PF614 to Advance Next-Generation Opioid Therapy Toward Regulatory Approval Receives $5.3 Million Installment from NIDA To Support Overdose Protection Program Accelerates PF614-MPAR-102 Study with Full Enrollment of Part 2 SAN DIEGO, CA / ACCESS Newswire / August 13, 2025 / 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, 2025. Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Momentum continued in the second quarter as we forged ahead progressing, what we believe will be the next evolution in opioid therapeutics: safety features built in to help guard against both misuse and overdose.

~ Productive FDA Meeting Highlights Path Toward Overdose Protection Labeling and 505(b)(2) Regulatory Strategy ~ ~ FDA and Ensysce Aligned on Collaborative Approach to Ensure Product's Full Safety Benefits are Recognized ~ SAN DIEGO, CA / ACCESS Newswire / July 31, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical innovator focused on redefining opioid safety, today announced that it received positive feedback and constructive guidance from the U.S. Food and Drug Administration (FDA) on the development of PF614-MPAR, the Company's first-of-its-kind opioid analgesic designed with both abuse deterrence and overdose protection. PF614-MPAR has earned the FDA's prestigious Breakthrough Therapy designation and is uniquely engineered using Ensysce's proprietary TAAP™ (Trypsin-Activated Abuse Protection) and MPAR® (Multi-Pill Abuse Resistance) technologies.

~ FDA Protocol Review Completed ~ ~ Rho, Inc. Selected as Clinical Research Partner ~ SAN DIEGO, CA / ACCESS Newswire / July 16, 2025 / Ensysce Biosciences, Inc. (NASDAQ:ENSC) ("Ensysce" or the "Company"), a clinical-stage pharmaceutical company pioneering novel solutions for severe pain with built-in abuse and overdose protection, today announced the initiation of its pivotal Phase 3 study of PF614, the Company's lead product candidate. This landmark study, PF614-301, ‘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' is designed to demonstrate PF614's ability to effectively manage post-surgical pain while protecting from abuse and offering patients what is believed to be a safer alternative to conventional opioids.