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ENSYSCE BIOSCIENCE WTS - ENSCW STOCK NEWS

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Ensysce Biosciences, Inc. (NASDAQ:ENSCW) is a clinical-stage company specializing in developing safer prescription drugs utilizing transformative chemistry to enhance drug safety. The company's TAAP(TM) prodrug of oxycodone, PF614, has shown positive results in clinical studies and provides a longer half-life, benefiting severe pain treatment. Ensysce's technology platforms, TAAP(TM) and MPAR(R), aim to provide tamper-proof treatment options to minimize drug abuse and overdose risks, with a focus on reducing medication abuse deaths.

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Ensysce Biosciences (NASDAQ:ENSC) provides a mid-year 2024 update on its clinical-stage pharmaceutical developments for severe pain relief with reduced opioid abuse and overdose potential. Key highlights include:

1. PF614: Completed End of Phase 2 FDA meeting, published bioequivalence study results, and established manufacturing partnerships.

2. PF614-MPAR: Received FDA Breakthrough Therapy designation, applied for $15 million NIH/NIDA grant, and advanced to second clinical trial.

3. Opioid Use Disorder (OUD) program: Selected lead drug candidate PF9001, a TAAP methadone analogue with potentially lower cardiovascular side effects.

The company is finalizing the PF614 Phase 3 protocol and anticipates initiating enrollment later in 2024. Ensysce continues to seek non-dilutive federal funding to support its innovative pain relief solutions.

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Ensysce Biosciences (NASDAQ:ENSC) announced it will host a symposium at the IASP 2024 World Congress on Pain on August 8, 2024, in Amsterdam. The symposium titled 'Severe Pain: A New Chapter for Safer Analgesics' will feature Dr. Lars Arendt-Nielsen and Dr. William Schmidt, who will discuss the landscape of severe pain treatment, trends in treatment, and the safety and effectiveness of Ensysce's PF614 and PF614-MPAR based on clinical data. CEO Dr. Lynn Kirkpatrick emphasized the importance of the event for presenting their technology platforms, TAAP and MPAR, which aim to reduce prescription drug abuse and overdose.

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Ensysce Biosciences (NASDAQ:ENSC), a clinical-stage pharmaceutical company, announced a partnership with manufacturing expert Purisys to scale the production of its lead opioid use disorder (OUD) drug candidate, PF9001. Developed using Ensysce's TAAP technology, PF9001 aims to reduce the cardiovascular side effects commonly associated with methadone. This collaboration aims to expedite the drug's progression to IND studies. Ensysce is also advancing its pain treatment candidate, PF614, towards Phase 3 trials. CEO Dr. Lynn Kirkpatrick highlighted Purisys' expertise in controlled substance chemistry and its role in improving the manufacturing processes for PF614.

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Ensysce Biosciences (NASDAQ: ENSC) has achieved a critical milestone in its opioid use disorder (OUD) program. The company has selected PF9001, a lead drug candidate designed to reduce abuse potential and improve safety, particularly with lower cardiovascular risks compared to traditional treatments. The candidate will proceed to Investigational New Drug (IND) enabling studies, backed by a $15 million NIH and NIDA HEAL award. CEO Dr. Lynn Kirkpatrick highlighted the adaptability of Ensysce's TAAP technology in producing controlled-activation drug candidates. Human clinical studies are expected to begin within 12 to 18 months.

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Ensysce Biosciences announced that its Chief Commercial Officer, Geoff Birkett, will participate in the EPHMRA 2024 Annual Conference in London from June 24-27, 2024. Birkett will be part of the opening panel discussion on June 25, titled 'The Future of Healthcare Market Research,' and will lead a presentation on June 26 about customer engagement strategy development. Birkett, known for his expertise in market research and commercialization, is pivotal in preparing for the launch of Ensysce's lead product, PF614, and the innovative follow-on drug, PF614-MPAR, an opioid with oral overdose protection. His insights have been essential in advancing Ensysce's portfolio aimed at severe pain relief while mitigating opioid misuse and overdose.

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Ensysce Biosciences has renewed its collaboration with Quotient Sciences to advance the clinical development of its overdose protection platform, PF614-MPAR. This innovative opioid product, designed to prevent overdose by shutting off opioid release when too many pills are ingested, is undergoing a Phase 1b study to evaluate its efficacy and safety across different doses. The study, PF614-MPAR-102, will assess doses of 25 mg, 50 mg, and 100 mg administered twice daily for five days. PF614-MPAR, which has received Breakthrough Therapy designation from the FDA, aims to provide a safer solution for severe pain management and address the ongoing opioid overdose crisis in the U.S.

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Ensysce Biosciences reported their first quarter 2024 financial results, highlighting progress in their clinical programs with FDA breakthrough therapy designations for their lead opioid products, PF614 and PF614-MPAR. The company received positive feedback and guidance from the FDA, affirming their path to regulatory approval and commercialization. Ensysce is set to begin Phase 3 clinical trials in the second half of 2024, showcasing their innovative TAAP and MPAR opioids for severe pain relief with reduced abuse potential.

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Ensysce Biosciences, a clinical stage pharmaceutical company (NASDAQ: ENSC), presented at the Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference. The webcast discussed the Company's innovative solutions for pain relief with reduced opioid abuse risk. CEO Dr. Lynn Kirkpatrick highlighted TAAP and MPAR technology, lead drug candidates PF614 and PF614-MPAR, FDA Breakthrough Therapy designation for PF614-MPAR, and upcoming milestones.
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Ensysce Biosciences, Inc. (ENSC) announces participation in Noble Capital Markets Emerging Growth Virtual Healthcare Equity Conference. The company focuses on developing innovative solutions for severe pain relief while reducing opioid misuse. Dr. Lynn Kirkpatrick and Dave Humphrey will present at the conference, offering a Q&A session. Attendees can register for the event for free and access the webcast later. Ensysce's management team will also be available for one-on-one meetings.
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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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FAQ

What is Ensysce Biosciences known for?

Ensysce Biosciences is recognized for developing safer prescription drugs using transformative chemistry to enhance drug safety.

What is the key product of Ensysce Biosciences?

The key product of Ensysce Biosciences is PF614, a TAAP(TM) prodrug of oxycodone providing a longer half-life and benefits in severe pain treatment.

How does Ensysce Biosciences aim to minimize drug abuse and overdose risks?

Ensysce Biosciences aims to provide tamper-proof treatment options through its technology platforms, TAAP(TM) and MPAR(R), to reduce drug abuse and overdose risks.

What sets Ensysce Biosciences apart?

Ensysce Biosciences stands out for its focus on reducing medication abuse deaths and offering innovative solutions in drug development.

What recent achievement has Ensysce Biosciences made?

Ensysce Biosciences achieved a significant milestone by selecting a lead drug candidate, PF9001, to treat opioid use disorder, demonstrating a lower potential for cardiovascular side effects and abuse profile.

ENSYSCE BIOSCIENCE WTS

Nasdaq:ENSCW

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7.40M
Biotechnology
Healthcare
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United States of America
La Jolla