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Ensysce Biosciences Inc - ENSC STOCK NEWS

Welcome to our dedicated news page for Ensysce Biosciences (Ticker: ENSC), a resource for investors and traders seeking the latest updates and insights on Ensysce Biosciences.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Ensysce Biosciences's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

Designed with both novice traders and seasoned investors in mind, our page aims to simplify the complex world of stock market news. By combining real-time updates, Rhea-AI's analytical insights, and historical stock performance data, we provide a holistic view of Ensysce Biosciences's position in the market.

Rhea-AI Summary
Ensysce Biosciences, Inc. reports financial results for Q4 and full year 2023, discusses FDA Breakthrough Therapy Designation, Phase 3 plans, and updates on TAAP and MPAR programs. The Company's CEO highlights progress in clinical studies and regulatory approvals, emphasizing the potential of their innovative opioid products.
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Rhea-AI Sentiment
End-of-Day
5.81%
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earnings
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Rhea-AI Summary
Ensysce Biosciences, Inc. (NASDAQ:ENSC) receives extension from Nasdaq to demonstrate compliance with equity requirement.
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-0.11%
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none
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Rhea-AI Summary
Ensysce Biosciences, Inc. (NASDAQ:ENSC) receives FDA guidance for its PF614-MPAR program, a 'Next Generation' opioid analgesic with overdose protection. The FDA provided feedback on non-clinical studies required for NDA submission and approval, streamlining development plans. PF614-MPAR, granted Breakthrough Therapy designation, aims to provide sustained pain relief with reduced adverse effects and overdose protection. Ensysce's lead drug candidate, PF614, has entered Phase 3 clinical development, demonstrating efficacy and safety.
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-2.11%
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none
Rhea-AI Summary
Ensysce Biosciences, Inc. announces positive results from the clinical study PF614-102 comparing PF614, a novel TAAP prodrug of oxycodone, to OxyContin. The study demonstrates a clear dose relationship between PF614 and oxycodone, achieving bioequivalence with OxyContin. PF614 offers advantages such as similar oxycodone exposures in fasted and fed states, a longer half-life, and potential as a twice-daily pain treatment. The manuscript published in Clinical and Translational Science highlights the safety and pharmacokinetics profile of PF614, positioning it as a promising analgesic for severe pain.
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Rhea-AI Sentiment
End-of-Day
-1.11%
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none
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Rhea-AI Summary
Ensysce Biosciences, Inc. (ENSC) announces the immediate exercise of warrants to purchase 3,601,752 shares of common stock at a reduced price, expecting gross proceeds of approximately $4.7 million. H.C. Wainwright & Co. acts as the exclusive placement agent for the offering.
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-24.56%
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Rhea-AI Summary
Ensysce Biosciences, Inc. (NASDAQ:ENSC) announced that their PF614-MPAR has been recognized as a potential medical breakthrough and was selected to present one of the top 12 best Flash Talks at the 2024 American Association of Pain Medicine (AAPM) Meeting. The company's novel PF614-MPAR is designed to provide optimal pain relief at prescribed doses yet limit accidental or intentional overdose by 'shutting down' opioid release if too much active drug is consumed. PF614-MPAR was granted Breakthrough Therapy designation by the FDA, recognizing its innovative approach to preventing prescription opioid overdoses. Ensysce's CEO and Chief Medical Officer expressed their enthusiasm and confidence in the potential of PF614-MPAR and its ability to disrupt the opioid market while mitigating the risk of overdose.
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Rhea-AI Sentiment
End-of-Day
-6%
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conferences
Rhea-AI Summary
Ensysce Biosciences, Inc. announces successful completion of End of Phase 2 meeting with FDA regarding its lead analgesic, PF614. The meeting facilitated affirmation of non-clinical program and constructive ideas exchange for Phase 3 trial designs. Clinical data shows PF614 is bioequivalent to OxyContin with a longer half-life, lower abuse potential, and significant analgesic activity. Phase 3 trials expected to begin in mid-2024.
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End-of-Day
12.5%
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clinical trial
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Rhea-AI Summary
Ensysce Biosciences, Inc. announces the presentation of their lead product, PF614-MPAR, at the NIH HEAL Initiative Scientific Meeting. The drug has been granted Breakthrough Therapy Designation by the FDA and has received funding from NIDA. The company aims to combat abuse and protect against oral opioid overdose, addressing the current opioid crisis. The presentation of the trial data reflects the successful optimization of the drug product, with potential to become a first-in-class 'Next Generation' opioid with abuse deterrent and oral overdose protection properties.
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Rhea-AI Sentiment
End-of-Day
12.78%
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conferences
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Rhea-AI Summary
Ensysce Biosciences, Inc. receives Breakthrough Therapy Designation (BTD) from the FDA for PF614-MPAR, a next-generation opioid with oral overdose protection. BTD is granted to drugs intended to treat serious conditions with potential for substantial improvement over available therapies. PF614-MPAR aims to provide pain relief while limiting accidental or intentional overdose, addressing the crisis of prescription overdose deaths in the US. The designation facilitates expedited development and review processes, highlighting the advancement made by Ensysce in treating severe pain.
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Rhea-AI Sentiment
End-of-Day
21.93%
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none
Rhea-AI Summary
Ensysce Biosciences, Inc. (NASDAQ: ENSC) made significant progress in 2023, focusing on delivering innovative approaches to severe pain with the unique benefit of overdose protection. The company aims to move its lead analgesic through to commercialization and expand its pipeline of products to treat pain. CEO Dr. Lynn Kirkpatrick expressed gratitude for shareholder support and outlined the corporate and clinical milestones achieved in the past year, with a focus on a transformational year in 2024.
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Rhea-AI Sentiment
End-of-Day
2.38%
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Ensysce Biosciences Inc

Nasdaq:ENSC

ENSC Rankings

ENSC Stock Data

5.86M
7.14M
5.7%
2.32%
2.74%
Pharmaceutical Preparation Manufacturing
Manufacturing
Link
United States
La Jolla

About ENSC

ensysce biosciences, san diego, ca, is an integrated drug delivery company for both small and large molecules. to overcome the major problem of non-medical use of opioid products, ensysce is using its prodrug technology to improve abuse deterrent properties. the tap bio-md™ abuse deterrent and mpar™ overdose resistant pain platforms, with worldwide intellectual patent protection, eliminate the ability to abuse opioid products by the non-oral route. this abuse is the fastest growing drug problem in the u.s. and it leads to billions in healthcare costs annually. for additional information about ensysce biosciences please visit www.ensysce.com.