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 clinical-stage pharmaceutical innovator developing safer opioid therapies through its patented TAAP and MPAR technologies. This dedicated news hub provides investors and healthcare professionals with essential updates on the company's progress in addressing prescription drug abuse.
Access real-time information about clinical trial milestones, regulatory submissions, and strategic partnerships. Our curated collection features press releases covering product development breakthroughs, intellectual property updates, and operational developments in pain management solutions.
Key content includes updates on abuse-deterrent formulation testing, FDA communication statuses, manufacturing collaborations, and financial performance reports. All materials maintain strict compliance with financial disclosure regulations while emphasizing patient safety advancements.
Bookmark this page for streamlined tracking of ENSC's mission to transform opioid therapy through biochemical innovation and rigorous clinical validation. Check regularly for verified updates directly from corporate communications and authorized news sources.
Ensysce Biosciences held a special meeting of stockholders on September 8, 2022, where key resolutions were approved. Stockholders voted in favor of:
- Issuing shares of common stock to certain investors, ensuring compliance with Nasdaq Listing Rule 5635(d).
- Implementing a Reverse Stock Split at a ratio between one-for-five and one-for-twenty.
- Increasing the number of authorized shares of common stock.
The decisions aim to strengthen the company’s capital structure and support ongoing clinical development initiatives.
Ensysce Biosciences has launched a redesigned corporate website highlighting its innovative TAAP and MPAR technology platforms aimed at improving prescription drug safety. The website aims to enhance communication about its unique, tamper-proof pain treatment options and the company's mission to combat drug abuse and overdoses. CEO Dr. Lynn Kirkpatrick emphasized the importance of showcasing their transformative chemistry as they progress towards commercialization. The redesign was executed by London-based Flipside Health, specializing in digital healthcare solutions.
Ensysce Biosciences (NASDAQ:ENSC, OTC:ENSCW), a clinical-stage biotech firm, announced its participation in several upcoming conferences aimed at improving prescription drug safety. Key events include the PAINWeek Conference from September 6-9, 2022, where CEO Dr. Lynn Kirkpatrick will chair a symposium, and the H.C. Wainwright 24th Annual Global Investment Conference from September 12-14, 2022. The meetings will provide opportunities for one-on-one discussions with company executives regarding their transformative technologies for pain management.
Ensysce Biosciences announced the successful completion of the clinical portion of study PF614-103, assessing the nasal abuse potential of its product PF614 compared to oxycodone. This trial is crucial for obtaining Abuse Deterrent labeling from the FDA. Data from the trial is expected in September 2022, and the study aims to demonstrate that PF614 cannot be abused through nasal inhalation. The results will further Ensysce's efforts to market PF614 as a safer pain management option.
Ensysce Biosciences released an updated investor presentation on August 17, 2022, accessible on their investor relations website. This presentation features data from the Bioequivalence study of PF614, a novel abuse-protected opioid, which compared its release of oxycodone to OxyContin. The company is focused on improving prescription drug safety and performance to mitigate abuse and overdoses. A corporate update call is scheduled for the same day at 11 AM ET, featuring key executives discussing company progress.
Ensysce Biosciences reported Q2 2022 financial results, showing a net loss of $7.9 million, up from $1.0 million the previous year. The company completed an $8 million financing, aiding clinical trial advancements. Positive bioequivalence data for PF614, an opioid designed to reduce abuse and overdose, was achieved, supporting FDA approval plans. Cash reserves fell to $3.7 million from $8.4 million in Q1, and R&D expenses surged to $5.3 million. Ensysce maintains a focus on developing safer pain management solutions.
Ensysce Biosciences announced positive data from its PF614-102 bioequivalence study, demonstrating that PF614, an abuse-protected opioid, meets FDA standards compared to OxyContin. The study involved 57 healthy volunteers and showed minimal absorption variability under different meal conditions. The findings could facilitate PF614's path to FDA approval via the 505(b)(2) regulatory pathway. Dr. Lynn Kirkpatrick highlighted this as a critical step toward providing a safer pain management alternative. A corporate update call is scheduled for August 17, 2022.
Ensysce Biosciences has initiated the PF614-103 study, testing the abuse potential of PF614 compared to oxycodone in recreational opioid users. This double-blind trial, led by Dr. Glen Apseloff, aims to confirm that PF614 cannot be misused via nasal inhalation. Chief Medical Officer Dr. Nily Osman emphasized the importance of this study in establishing PF614's safety profile, as it requires trypsin activation for efficacy, significantly reducing abuse risk. Results are anticipated by October 2022, which will help differentiate PF614 from traditional opioids.
Ensysce Biosciences has secured $8 million in funding through a convertible note agreement with institutional investors, supporting its mission to enhance opioid safety. The financing includes senior secured convertible notes and warrants, with $4 million received in an initial closing. The funds will aid in advancing clinical studies for its abuse deterrent products. The notes are convertible at a 10% premium and bear a 6% interest rate, maturing in 18 months. The company continues to prioritize developing safer prescription drugs utilizing its unique technologies.
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