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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 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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Ensysce Biosciences Announces Key Efficacy Data for Lead Analgesic

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Ensysce Biosciences, Inc. (NASDAQ:ENSC) announced positive results from the PF614-201 study, demonstrating significant pain intensity reduction and fast onset of action for PF614, a next-generation analgesic. The study data supports the design of Phase 3 studies and FDA evaluation in 2024, positioning the company to advance the development of PF614 for the treatment of severe pain.
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Ensysce Biosciences Discusses TAAP and MPAR(R) Applications and OncoZenge Partnership with The Stock Day Podcast

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Ensysce Biosciences (NASDAQ:ENSC) is a clinical-stage company using proprietary technology platforms to develop safer prescription drugs. CEO Dr. Lynn Kirkpatrick discussed the company's progress on The Stock Day Podcast.
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Ensysce Biosciences Announces Completion of $1.7 Million Convertible Note Financing

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Ensysce Biosciences, Inc. (NASDAQ:ENSC) completes a private placement with investors for senior secured convertible notes and warrants, raising an aggregate investment of $1.7 million. The company's CEO, Dr. Lynn Kirkpatrick, expresses confidence in the unique technologies and the funding's support for the completion of a time of onset study and regulatory milestones for PF614, Ensysce's lead product. The private placement includes the issuance of notes convertible into common stock and warrants for the right to purchase additional shares, meeting the minimum price requirement established by The Nasdaq Stock Market.
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Ensysce Biosciences and OncoZenge Announce Letter of Intent for the Co-development of BupiZenge(TM) in the United States

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Ensysce Biosciences, Inc. (ENSC) and OncoZenge AB (ONCOZ) sign a letter of intent to collaborate on the development and commercialization of BupiZenge™, a non-opioid oral formulation of the local anesthetic bupivacaine for the treatment of oral mucositis associated with cancer treatment. OncoZenge has successfully progressed BupiZenge™ through Phase 2 in the EU and is planning for the registrational Phase 3 program. The collaboration aims to accelerate the introduction of BupiZenge™ to the US market to address critical unmet needs in analgesia and oncology.
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Ensysce Biosciences Announces Enrollment Completion for PF614-201 Clinical Study

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Ensysce Biosciences, Inc. (NASDAQ:ENSC) announced the completion of enrollment for the PF614-201 study, a critical step towards Phase 3 evaluation of PF614. The study aims to confirm the onset time for PF614 analgesic effects, with trial results expected in December 2023. The company's Chief Medical Officer highlighted the significance of this milestone, emphasizing the potential of PF614 to provide longer and safer exposure to analgesic levels compared to OxyContin, with lower abuse potential.
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Ensysce Biosciences Reports Third Quarter 2023 Financial Results

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Ensysce Biosciences, Inc. (NASDAQ: ENSC) reported Q3 2023 financial results and progress on clinical trials for PF614 and PF614-MPAR, with expected clinical study results by year-end. The company aims to enter Phase 3 evaluation of PF614 and PF614-MPAR for overdose protection, with a focus on improving prescription drug safety and reducing opioid abuse. The financial results show a decrease in cash and cash equivalents, but an increase in federal grants and a reduction in research and development expenses.
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Ensysce Biosciences Secures $1.7 Million Convertible Note Financing

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Ensysce Biosciences, Inc. has entered into a securities purchase agreement with investors for an aggregate investment of $1.7 million. The funding will support the clinical development of their lead product and advance their unique technologies. The Notes are convertible into shares of Ensysce common stock at a conversion price of $1.5675 and the Warrants have the right to purchase up to 1,255,697 shares of common stock at an exercise price of $1.5675.
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FAQ

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

The current stock price of Ensysce Biosciences (ENSC) is $0.65 as of November 1, 2024.

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

The market cap of Ensysce Biosciences (ENSC) is approximately 9.7M.

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

ENSC Rankings

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ENSC Stock Data

9.69M
14.91M
1.17%
3.35%
0.82%
Biotechnology
Pharmaceutical Preparations
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United States of America
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