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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.
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.
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.
Ensysce Biosciences, a clinical-stage pharmaceutical company (NASDAQ: ENSC), shared key insights from the 2024 EPHMRA Annual Meeting, held in London on June 25-26. Geoff Birkett, Chief Commercial Officer, participated in discussions about the future of healthcare research and emphasized the importance of new technologies in addressing pain and opioid abuse. Ensysce's TAAP™ and MPAR® platforms were highlighted as examples of innovative solutions. Birkett also led a session on integrating AI and human intelligence in drug development, underscoring the need for active involvement from company staff and prescribers. He expressed optimism about the potential of advanced technologies to improve patient lives and stressed the ongoing importance of research in drug development. Additionally, the meeting reinforced the significance of combining AI with human insights.
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.
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.
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.
Ensysce Biosciences has regained compliance with Nasdaq's Listing Rule 5550(b)(1), according to a notice received on May 24, 2024.
The compliance relates to the equity requirement as per the Hearing Panel's decision dated February 26, 2024. As a result, Ensysce's common stock will continue to trade on Nasdaq's Capital Market tier.
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.
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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