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.
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 submitted its Phase 3 protocol to the FDA for PF614, a novel opioid designed to treat moderate to severe post-surgical pain. The study, PF614-301, will evaluate the efficacy and safety of PF614 compared to placebo and an active comparator in patients undergoing abdominoplasty. Key features of PF614 include:
1. Longer-lasting pain relief (twice the duration of OxyContin)
2. Reduced abuse potential
3. Potential to address breakthrough pain between doses
The company expects to conduct the trial across 4-6 U.S. clinical sites, with results anticipated in late 2025. This submission marks a significant milestone in PF614's development as a 'next-generation opioid' for short-term severe pain management.
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 announced a $5 million concurrent registered direct offering and exercise of warrants. The company will issue and sell 3,553,194 shares of common stock at $0.47 per share. Additionally, certain outstanding warrants to purchase 7,203,504 shares will be exercised at a reduced price of $0.47 per share. In a private placement, Ensysce will issue unregistered Series A-3 and A-4 warrants to purchase up to 14,358,450 shares each. The offerings are expected to close around August 29, 2024. H.C. Wainwright & Co. is the exclusive placement agent. Ensysce plans to use the proceeds for developing its TAAP and MPAR programs and for working capital, supplementing a recent $14 million NIH grant for PF614-MPAR development.
Ensysce Biosciences (NASDAQ:ENSC) has received IRB approval for the PF614-MPAR-102 protocol, marking a significant milestone in the clinical development of their FDA-designated Breakthrough Therapy for severe pain relief. This study, supported by a $14 million federal grant, will evaluate the pharmacokinetics of oxycodone and PF614 when co-administered with nafamostat. PF614-MPAR is unique as the only opioid with both abuse and overdose protection to receive Breakthrough Therapy designation. The company plans to initiate the three-part trial immediately, with first data expected in mid-2025. This development brings Ensysce closer to introducing a new generation of safer pain management products.
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) reported Q2 2024 financial results and provided updates on its opioid programs. Key highlights include:
- PF614-MPAR advancing to Phase 1b study
- PF9001 selected as lead candidate for Opioid Use Disorder program
- PF614 Phase 3 protocol being finalized for FDA submission
- Q2 cash position of $1.0 million
- Q2 net loss of $2.0 million, down from $2.2 million in Q2 2023
- R&D expenses decreased to $0.9 million from $1.6 million year-over-year
The company is progressing its TAAP™ and MPAR® technologies to develop safer opioid analgesics with abuse deterrent and overdose protection features.
Ensysce Biosciences (NASDAQ:ENSC) hosted a successful symposium at the International Association for the Study of Pain (IASP) 2024 World Congress in Amsterdam. The symposium, titled 'Severe Pain: A New Chapter for Safer Analgesics', focused on innovative solutions for severe pain relief while reducing opioid abuse and overdose risks. Key discussions included:
1. Current landscape of severe pain treatment
2. new therapeutic agents in the past decade
3. Pros and cons of opioid use and genetic influences on pain
4. Ensysce's Trypsin Activated Abuse Protection (TAAP) and Multi-Pill Abuse Resistance (MPAR) technologies
5. Safety and effectiveness of PF614 and PF614-MPAR
6. Upcoming clinical studies and commercial positioning
The symposium received positive feedback on its content and Ensysce's clinical strategy.
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