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) has secured a commitment for future supply of GMP nafamostat from Aurore Life Sciences. This agreement is important for PF614-MPAR, the company's overdose protection drug product, as nafamostat is a vital component. The partnership allows Ensysce to reference Aurore's Drug Master File and fully secures the supply chain for PF614-MPAR, which is currently advancing through clinical development. Additionally, the company has initiated other programs using nafamostat as a single agent for various indications, which will also benefit from this supply agreement.
Ensysce Biosciences (NASDAQ:ENSC) has announced a strategic partnership with a leading specialty drug manufacturer for the development and commercial launch of PF614 and PF614-MPAR drug products. The partnership includes a $10 million commitment and involves the manufacturer taking an equity position in Ensysce.
The collaboration will provide Ensysce with clinical trial material, drug products for regulatory submissions, and initial commercial batches. The partner will handle the complete manufacturing process, including packaging, labeling, and shipment. This partnership secures key Chemistry Manufacturing and Control (CMC) elements for the New Drug Application (NDA) submission, supporting the company's goal of achieving regulatory approval for their innovative pain relief solutions.
Ensysce Biosciences (NASDAQ:ENSC) has announced a 1-for-15 reverse stock split effective December 6, 2024, at 12:01 a.m. Eastern Time. The company's stock will continue trading under the symbol 'ENSC' with a new CUSIP number 293602 504.
The primary purpose of this reverse split is to increase the bid price of the company's common stock to meet Nasdaq's minimum bid requirement of $1.00 per share for continued listing. Every 15 shares will be automatically combined into 1 share, with fractional shares rounded up to the nearest whole number. Stockholders' proportional ownership will remain unchanged, except for minor adjustments due to fractional share treatment.
Ensysce Biosciences (NASDAQ:ENSC) has initiated dosing in the PF614-MPAR-102 study, marking a significant milestone for its breakthrough therapy-designated opioid drug. The trial aims to evaluate the pharmacokinetics of oxycodone and PF614 when co-administered with nafamostat. The study received a $14 million multi-year award from NIDA and expects early interim data in Q1 2025. The three-part trial will assess the full dosage range, food effects, and conduct multi-ascending dose studies of PF614-MPAR, which is designed to reduce deliberate and accidental overdoses in severe pain treatment.
Ensysce Biosciences (NASDAQ:ENSC) reported Q3 2024 financial results, highlighting a $14 million NIH grant for PF614-MPAR development and the initiation of its second clinical trial. The company submitted a pivotal Phase 3 protocol for PF614 to FDA review. Cash position improved to $4.2 million from $1.1 million at 2023-end. Q3 showed net income of $0.7 million, compared to a $2.7 million loss year-over-year, primarily due to increased federal grant funding of $3.4 million. R&D expenses decreased to $1.7 million from $1.9 million, while G&A expenses slightly declined to $1.1 million.
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 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.
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