AwesomeStocks Donât want emails from us anymore? Click [here]( to unsubscribe. Hello! New Alert: Ensysce Biosciences, Inc. (NASDAQ: ENSC) ENSC is our new NASDAQ high volatility alert with a bounce opportunity. ENSC has a history of experiencing significant volatility in a short period of time. ENSC could be presenting a unique opportunity where it has significantly deviated from its 50 day moving average. While an increased gap does not suggest that it will get smaller, it does create the opportunity for upside potential. ENSC has a 50 day moving average of 0.71, more than 36% above Fridayâs close. In addition, ENSC has a RSI of only 29, suggesting the potential for increased upside. In the event that ENSC holds above its recent lows, there exists potential for a rally higher. ENSC is a NASDAQ listed âclinical-stage company using its proprietary technology platforms to develop safer prescription drugsâ. As the company further explains: âLeveraging its Trypsin-Activated Abuse Protection (TAAPâ¢) and Multi-Pill Abuse Resistance (MPAR®) platforms, the Company is developing unique, tamper-proof treatment options for pain that minimize the risk of both drug abuse and overdose.â The companyâs âproducts are anticipated to provide safer options to treat patients suffering from severe pain and assist in preventing deaths caused by medication abuseâ. Furthermore, âThe platforms are covered by an extensive worldwide intellectual property portfolio for a wide array of prescription drug compositions.â Sadly, according to the CDC, âOpioids were involved in 80,411 overdose deaths in 2021 (75.4% of all drug overdose deaths)â. In February, the company announced: âEnsysce Biosciences Announces Successful Meeting with FDA for PF614-MPAR, a Next Generation Opioid with Overdose Protectionâ As the company further explained: âThe meeting focused on the Company's non-clinical program for the combination product that is designed for the treatment of severe pain. The FDA provided helpful feedback and advice on non-clinical studies that are required for eventual new drug application (NDA) submission and approval. The guidance will aid in streamlining the development plans for this innovative drug candidate to bring PF614-MPAR to the market as quickly as possible.â Furthermore: âAs recently announced, PF614-MPAR was granted Breakthrough Therapy designation by the FDA which allows more frequent meetings and access to FDA experts. PF614-MPAR is a combination product of PF614, a trypsin-activated abuse protection (TAAP) oxycodone prodrug, and a trypsin inhibitor, nafamostat. PF614, Ensysce's lead drug candidate and the base for PF614-MPAR, has entered Phase 3 clinical development following its demonstration of efficacy and safety in recent trials and a recent End of Phase 2 meeting with the FDA.â Importantly: âThe clinical data demonstrated that PF614 delivers oxycodone with the benefit of a longer half-life than products currently on the market, providing what Ensysce believes will be more sustained pain relief with reduced adverse effects that occur following repeat dosing of shorter-acting opioid analgesics. PF614-MPAR takes the product to the next level with overdose protection, by the addition of nafamostat which "switches off" the release of oxycodone when too many doses are ingested simultaneously. This approach to drug safety is first-in-class and has the potential to beneficially impact many lives.â Here are some of the comments from this press release: "We are appreciative of guidance provided by the FDA to help us develop PF614-MPAR," commented Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce. "The fact that we have been granted Breakthrough Therapy status is a sign of the critical nature of this product. As a country, we are still losing two Americans every hour to opioid prescription overdose. My team now has an approach to attack this problem with what we believe will be a game-changing opioid analgesic that has the potential to reduce opioid overdoses while providing better control of severe acute and chronic pain. We also believe that our approach can benefit both new and existing drugs with improved therapeutic outcomes and reduced abuse." The company also announced: âEnsysce Biosciences Receives Positive Nasdaq Listing Determinationâ âSAN DIEGO, CA / ACCESSWIRE / February 27, 2024 / Ensysce Biosciences, Inc. (the "Company") (NASDAQ:ENSC), a clinical-stage company applying transformative chemistry to improve prescription drug safety, today announced that it has received notice from The Nasdaq Stock Market LLC ("Nasdaq"), as described in a decision dated February 26, 2024, that the Company may continue its listing on The Nasdaq Capital Market tier with an extension to May 13, 2024 in order to demonstrate compliance with the equity requirement in Listing Rule 5550(b)(1).â In March, the company announced: âEnsysce Biosciences Reports Fourth Quarter and Full Year 2023 Financial Resultsâ Here are some of the companyâs comments from this press release: "Importantly, the collective empirical data we've received from four completed clinical studies verify PF614's bioequivalence to commercially available opioids but with reduced abuse potential, and reaffirms our belief that Ensysce's PF614 will provide a "next generation" opioid family with the added value proposition of safer products with overdose protection. We have many reasons to remain optimistic on our path to regulatory approval as we advance through our Phase 3 clinical trials beginning in the second half of 2024. Progress in 2023 and early 2024 has provided further evidence that our innovative analgesics will provide prescribers and patients in severe pain with an alternative, effective option with safety advantages to address the opioid epidemic in the United States," concluded Dr. Kirkpatrick. In April, the company announced: - âEnsysce Biosciences' Presentation from the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference Publishedâ
- âEnsysce Biosciencesâ CEO Dr. Lynn Kirkpatrick Featured in Xtalks Clinical Edge Magazineâ In addition, just this morning, the company announced breaking news: âEnsysce Biosciences Reports First Quarter 2024 Financial Resultsâ Here are some of the highlights from this press release: - âPF614's Phase 3 Clinical Plans Affirm the Path to Regulatory Approvalâ
- âFDA Breakthrough Therapy Designation of PF614-MPAR Expedites Clinical Programâ Make sure to do your own due diligence. 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. DISCLAIMER You should read and understand this disclaimer in its entirety before joining the website or email/blog list of AwesomeStocks.com (the âPublisherâ). 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