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Ensysce Biosciences, Inc. - ENSC STOCK NEWS

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

Ensysce Biosciences, Inc. (NASDAQ: ENSC) is a San Diego-based clinical-stage biotech company specializing in the development of safer prescription drugs using its proprietary technology platforms. The company focuses on creating new, tamper-proof opioids that aim to reduce drug abuse and prevent overdoses. Ensysce leverages its Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) platforms to develop innovative pain relief options with a lower risk of misuse.

The company’s core projects include two key drug platforms: the TAAP technology, which activates upon ingestion to release pain medication, and the MPAR technology, designed to prevent overdose by inhibiting further release of the drug when excess doses are consumed. These platforms are supported by global intellectual property protection, ensuring a wide array of prescription drug compositions.

Recent milestones include the FDA’s Breakthrough Therapy designation for PF614-MPAR, a combination product designed to provide overdose protection alongside effective pain relief. This designation accelerates the drug’s development and review process, highlighting its potential to offer substantial improvements over existing therapies. Ensysce’s lead candidate, PF614, is currently in Phase 3 clinical development, having demonstrated efficacy and safety in previous trials.

In terms of financial health, Ensysce has shown stability, with recent funding from federal grants and warrant exercises supporting ongoing research and development. The company's collaboration with Quotient Sciences aims to further optimize their PF614-MPAR drug product, enhancing its effectiveness and safety profile.

Ensysce is also expanding its product pipeline to address opioid use disorder (OUD) with PF9001, a TAAP-based candidate that has shown promise in reducing cardiovascular side effects compared to traditional treatments. Supported by a multi-year HEAL grant from the NIH and NIDA, this candidate is poised to enter human clinical studies within the next 12 to 18 months.

For more detailed information about Ensysce Biosciences, Inc. and its innovative projects, please visit www.ensysce.com.

News

Ensysce Biosciences Receives Positive Nasdaq Listing Determination

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Ensysce Biosciences, Inc. (NASDAQ:ENSC) receives extension from Nasdaq to demonstrate compliance with equity requirement.
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Ensysce Biosciences Announces Successful Meeting with FDA for PF614-MPAR, a Next Generation Opioid with Overdose Protection

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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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Ensysce Biosciences Announces Publication of Clinical Bioequivalence Manuscript

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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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Ensysce Biosciences, Inc. Announces Exercise of Warrants for $4.7 Million Gross Proceeds

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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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Ensysce Biosciences Selected to Present at American Association of Pain Medicine Annual Conference

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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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Ensysce Biosciences Announces Positive End of Phase 2 Meeting with FDA for PF614 to Treat Severe Pain

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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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Ensysce Biosciences to Present Groundbreaking Oral Overdose Protection for Opioids at the 5th Annual NIH HEAL Meeting

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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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Ensysce Biosciences Announces FDA Breakthrough Therapy Designation Granted for PF614-MPAR

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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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Ensysce Biosciences Issues 2024 Shareholder Letter

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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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Ensysce Biosciences Postpones Special Meeting of Stockholders to December 29, 2023

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Ensysce Biosciences, Inc. (NASDAQ:ENSC) postpones Special Meeting of Stockholders due to lack of required quorum, rescheduled for December 29, 2023.
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FAQ

What is the current stock price of Ensysce Biosciences (ENSC)?

The current stock price of Ensysce Biosciences (ENSC) is $8.1 as of December 20, 2024.

What is the market cap of Ensysce Biosciences (ENSC)?

The market cap of Ensysce Biosciences (ENSC) is approximately 9.8M.

What is Ensysce Biosciences, Inc.?

Ensysce Biosciences, Inc. is a clinical-stage biotech company in San Diego focused on developing safer prescription drugs using proprietary abuse deterrent and overdose protection technologies.

What technologies does Ensysce use in its drug development?

Ensysce employs its proprietary Trypsin-Activated Abuse Protection (TAAP™) and Multi-Pill Abuse Resistance (MPAR®) technologies to create tamper-proof drugs that minimize the risk of abuse and overdose.

What are the core products in Ensysce’s development pipeline?

The core products include PF614, an extended-release oxycodone utilizing TAAP technology, and PF614-MPAR, which combines overdose protection with effective pain relief.

What recent achievements have Ensysce made?

Ensysce has received Breakthrough Therapy designation from the FDA for PF614-MPAR, highlighting the product's potential to improve pain management while preventing overdoses.

What is the significance of FDA Breakthrough Therapy designation?

The Breakthrough Therapy designation expedites the development and review process for drugs that show substantial improvement over existing therapies, facilitating faster access to patients.

How is Ensysce addressing the opioid epidemic?

Ensysce is developing tamper-proof opioids that reduce the risk of abuse and overdose, with products like PF614-MPAR designed to prevent the release of excess doses and provide safer pain management options.

What financial strategies support Ensysce’s operations?

Ensysce’s financial health is bolstered by federal grants and warrant exercises, which help fund its ongoing research and development efforts.

What partnerships has Ensysce formed to advance its drug development?

Ensysce collaborates with Quotient Sciences to optimize and test its drug products, enhancing their safety and effectiveness through innovative translational pharmaceutics processes.

What future projects is Ensysce Biosciences involved in?

Ensysce is expanding its pipeline to include PF9001 for opioid use disorder (OUD), supported by significant funding from the NIH and NIDA to move into human clinical studies.

Where can more information about Ensysce Biosciences be found?

Additional details about Ensysce Biosciences can be found on their official website at www.ensysce.com.

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Ensysce Biosciences, Inc.

Nasdaq:ENSC

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ENSC Stock Data

9.79M
895.96k
1.17%
22.26%
42.61%
Biotechnology
Pharmaceutical Preparations
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