Welcome to our dedicated page for Ensysce Biosciences news (Ticker: enscw), a resource for investors and traders seeking the latest updates and insights on Ensysce Biosciences stock.
Overview of Ensysce Biosciences Inc.
Ensysce Biosciences Inc. is a clinical-stage pharmaceutical company dedicated to transforming patient care with innovative, abuse-deterrent technologies. Leveraging its proprietary TAAP (Trypsin-Activated Abuse Protection) and MPAR (Multi-Pill Abuse Resistance) platforms, the company is focused on developing tamper-proof, safer opioid therapies that address severe pain while reducing risks associated with opioid abuse and overdose. With a strategic emphasis on opioid abuse prevention, abuse-deterrent technology, and clinical-stage pharmaceutical innovation, Ensysce has positioned itself as a key player in the ongoing evolution of pain management.
Core Business and Clinical Programs
Ensysce Biosciences is at the forefront of overcoming challenges in the current opioid landscape. The company is actively progressing several clinical programs, including:
- PF614: A novel TAAP opioid designed to provide effective analgesia for severe pain while mitigating abuse potential by remaining inactive until activated in the body.
- PF614-MPAR: A breakthrough therapy candidate that pairs the innovative TAAP modification with an inbuilt overdose protection feature, offering an extra layer of safety for patients.
- PF9001: A lead candidate in the opioid use disorder (OUD) program developed using TAAP technology, aiming to reduce cardiovascular side effects compared to traditional OUD treatments.
Technological Innovation and Market Position
The science behind Ensysce’s platforms is designed with the dual goal of patient safety and therapeutic efficacy. By utilizing endogenous enzymes to activate drug release, the TAAP technology ensures that the medication’s active form is delivered only when appropriately ingested. In parallel, the MPAR strategy offers a safeguard against overconsumption, effectively 'turning off' drug release when an excessive dose is taken. This combination of strategies positions the company uniquely within the pharmaceutical industry, which faces increasing scrutiny over opioid safety and abuse.
Regulatory and Collaborative Milestones
Ensysce has achieved significant regulatory milestones, including Breakthrough Therapy designation from the FDA for its PF614-MPAR candidate. These endorsements reflect both the potential clinical benefits of its products and the rigorous scientific approach employed in their development. Moreover, the company’s strategic collaborations with experienced manufacturing partners and research organizations further enhance its capability to scale and optimize production, positioning it competitively in a challenging market environment.
Intellectual Property and Future Directions
Ensysce’s operations are supported by an extensive worldwide portfolio of intellectual property that covers a diverse range of prescription drug compositions. This robust IP framework safeguards its innovative platforms and supports long-term investment in research and development. Despite operating within a competitive and highly regulated space, Ensysce’s emphasis on tamper-proof, safer drug formulations provides a compelling value proposition for healthcare providers and patients alike.
Why Investors and Industry Experts Should Note Ensysce
The company's dedicated focus on mitigating prescription drug abuse and delivering safer pain management solutions aligns with pressing public health needs. Its dual-platform approach not only enhances patient safety but also sets new standards in drug development. This comprehensive, methodical approach to addressing opioid abuse and overdose distinguishes Ensysce Biosciences in the clinical-stage pharmaceutical sector.
Ensysce Biosciences (NASDAQ:ENSC) has received a positive determination from Nasdaq regarding its listing status. The company has been granted an extension until November 14, 2024, to demonstrate compliance with the equity requirement by filing its Form 10-Q. Additionally, Nasdaq extended the deadline to December 19, 2024, for meeting the Minimum Bid Price requirement and other applicable conditions to maintain its listing on The Nasdaq Capital Market.
Ensysce Biosciences (NASDAQ:ENSC) announced its leadership team's participation in the 18th Annual Pain Therapeutics Summit on October 28-29, 2024, in Boston. Dr. Lynn Kirkpatrick, CEO, will present "When All You Have is a Hammer ... A New Approach to Soften the Blow" on October 28th at 1:00 PM ET. She will discuss Ensysce's TAAP™ and MPAR® opioid classes, including PF614 and PF614-MPAR, which aim to provide effective pain relief with reduced abuse potential and overdose protection.
Dr. William Schmidt, CMO, will serve as Chairperson for the second consecutive year, providing opening remarks on both days. The summit brings together leaders in advanced medicine, science, academia, and government to discuss the latest advances in novel pain therapies development.
Ensysce Biosciences (NASDAQ:ENSC), a clinical-stage pharmaceutical company developing innovative solutions for severe pain relief while reducing opioid abuse potential, provided a shareholder update. Key points include:
1. The company believes it's in compliance with Nasdaq requirements and awaits a hearing to discuss maintaining compliance.
2. Ensysce raised $5 million in gross proceeds and received a $14 million NIH grant.
3. The PF614-301 Phase 3 Protocol for a pivotal study was submitted to the FDA, with results expected in late 2025.
4. PF614-MPAR studies are progressing with non-dilutive funding.
5. The company aims to submit a New Drug Application for PF614 by 2026, with potential commercialization by year-end.
6. Ensysce is in discussions with potential partners to expand commercial success of PF614 and PF614-MPAR.
Ensysce Biosciences (NASDAQ:ENSC) has announced its participation in two upcoming meetings in October 2024. At the Society for Neuroscience meeting on October 5, new data will be presented on their Opioid Use Disorder (OUD) program, showcasing a study on methadone's effects in a modified rat model of physical dependence. This research, conducted with Sygnature Discovery, aims to develop novel methadone analogues with reduced cardiovascular side effects and abuse potential using Ensysce's Trypsin Activated Abuse Protection (TAAP) technology.
On October 16, Ensysce's CEO, Dr. Lynn Kirkpatrick, will present at the Formulation & Delivery US 2024 meeting, discussing their TAAP and MPAR platforms and highlighting their lead products, PF614 and PF614-MPAR. These products have received Fast Track and Breakthrough Therapy designations from the FDA, demonstrating their unique approach to delivering effective drugs more safely and efficiently.
Ensysce Biosciences (NASDAQ:ENSC) has released two video segments from its symposium at the International Association for the Study of Pain (IASP) 2024 World Congress in Amsterdam. The symposium focused on opioid use worldwide and Ensysce's innovative opioid drug products for severe pain relief. Dr. William Schmidt, CMO, explained the government support received from NIH and FDA, and highlighted how PF614, Ensysce's lead agent, aligns with ideal pain product characteristics. CEO Dr. Lynn Kirkpatrick emphasized the company's novel approach using TAAP and MPAR platforms to develop opioids with reduced abuse and overdose potential. Ensysce plans to begin a Phase 3 pivotal trial soon and explore PF614's use in cancer treatment, aiming to provide prescribers with new options for effective patient care.
Ensysce Biosciences (NASDAQ:ENSC) has received a $14 million multi-year grant from the NIH and National Institute on Drug Abuse (NIDA) for the continued development of PF614-MPAR, an abuse-deterrent opioid with overdose protection. This follows the FDA's Breakthrough Therapy designation for PF614-MPAR in January 2024. The funding will support the completion of the Phase 1b clinical trial, PF614-MPAR-102, over approximately three years.
PF614-MPAR is designed to provide optimal pain relief at prescribed doses while limiting accidental or intentional overdose. This grant brings the total federal funding awarded to Ensysce to $40 million, supporting their mission to develop innovative solutions for severe pain relief with reduced potential for opioid abuse and overdose.
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 (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.
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