Update

AwesomeStocks Don’t want emails from us anymore? Click [here]( to unsubscribe. Hello! We wanted to update ENSC, our new alert, discussing more in-depth the company’s news from this morning. Here is the announcement from this morning: “Ensysce Biosciences Reports First Quarter 2024 Financial Results” “SAN DIEGO, CA / ACCESSWIRE / May 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, today reported financial and operational results for the first quarter ended March 31, 2024.” As the company explains: “Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "In the first quarter of 2024, we continued to accelerate the progress of our clinical programs toward regulatory approvals. Early in the quarter, a constructive end of Phase 2 meeting was held with the U.S. Food & Drug Administration (FDA) for our lead opioid product, PF614, providing solid guidance for a Phase 3 clinical trial expected to initiate in the second half of 2024. The FDA also provided guidelines to reduce the regulatory risks for our commercialization plan.” “Additionally, in January, the FDA's grant of Breakthrough Therapy designation for PF614-MPAR affirms belief in our novel approach to providing the ‘Next Generation' of opioid products. This exclusive designation, granted to fewer than 300 drugs since its introduction in 2012, was based on data generated in our Phase 1 study, PF614-MPAR-101, which demonstrated that the unique combination can add oral overdose protection to our prescription TAAP (Trypsin-Activated Abuse Protection) products. This designation is intended to accelerate product development and provide guidance to aid the design of our PF614-MPAR programs to efficiently move toward a new drug application (NDA) submission and approval of this innovative opioid. Coupled with the previously granted Fast Track designation for PF614, Breakthrough Therapy designation for PF614-MPAR demonstrates the FDA's recognition of these transformational pain medications." “Dr. Kirkpatrick added, "We look forward to beginning our Phase 3 clinical trials in the second half of 2024. We believe the data we have generated to date from multiple clinical studies de-risk our path to commercialization. These studies have verified PF614 delivers oxycodone in an equivalent manner to commercially available opioids and provides pain relief with reduced abuse potential. We believe our TAAP and MPAR (Multi-Pill Abuse Resistance) opioids have a proven safety profile that surpasses the current slate of extended-release opioid analgesics, and we look forward to providing additional milestones and updates in the months ahead," concluded Dr. Kirkpatrick.” “TAAP TM (Opioid Abuse Deterrent Program) Update” “Our lead product, PF614, is a Trypsin-Activated Abuse Protection (TAAP TM ) extended-release oxycodone and a potential "next generation" analgesic for severe pain. The Company's TAAP TM technology is designed to control release, be highly resistant to tampering, and reduce abuse through a unique chemical modification. PF614's TAAP TM modification makes it inactive until it is swallowed, following which it is activated or "turned on" to release oxycodone by the body's own trypsin, an enzyme in the small intestine. As mentioned, Ensysce recently received FDA guidance on the strategy and design of its Phase 3 clinical program and expects to commence enrollment for the Phase 3 clinical trial in the second half of 2024.” “MPAR® (Opioid Abuse Deterrent and Overdose Protection Program) Update” “PF614-MPAR is a combination product of the TAAP prodrug PF614 with a trypsin inhibitor, designed to treat severe pain while providing overdose protection. MPAR® (Multi-Pill Abuse Resistance) reduces or "turns off" the release of the opioid to prevent an overdose, providing an additional layer of protection to Ensysce's TAAP™ medications. Over the past year, clinical data demonstrated that the MPAR® technology reduces release and absorption of oxycodone from PF614 when consumed in more than a prescribed dose.” “Ensysce received notice from the FDA that it had granted Breakthrough Therapy designation for PF614-MPAR, specifically acknowledging the potential impact of the innovative MPAR® overdose protection technology. Breakthrough Therapy is an elite designation that expedites the development and review of drugs that are intended to treat a serious condition where the drug may demonstrate substantial improvement over available therapies.” “In February, the Company received additional productive guidance from the FDA to aid the execution of our PF614-MPAR programs to efficiently move toward a new drug application (NDA) submission and approval to bring this innovative drug to market.” Following the news this morning, ENSC opened at 0.55 and so far, rallied to a high of 0.59, upside of 7%. As a reminder, ENSC could be presenting a unique opportunity where it has significantly deviated from its 50 day moving average. ENSC has a 50 day moving average of 0.70, 27% above today’s open. While an increased gap does not suggest that it will get smaller, it does create the opportunity for upside potential. In the event that ENSC holds above its recent lows, there exists potential for a rally higher. We are continuing to monitor this opportunity. Sources: [CDC]( [CE]( [Presentation]( [PR1]( [PR2]( [PR3]( [PR4]( [PR5]( [PR6]( [PR7]( [Website]( [Chart]( Happy Trading! AwesomeStocks Note: We encourage all traders and investors to develop personal trading rules that you can follow and that work for you. Always protect your downside and note that we alert extremely volatile short-term opportunities. Before investing in securities, you should always consult with your financial, tax and legal advisor and never invest money you cannot afford to lose. 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