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 reported its Q4 and full-year 2021 results, showing a net loss of $29.1 million, heavily influenced by non-cash expenses of $17.9 million related to convertible notes and warrants. Cash and equivalents increased to $12.3 million from $0.2 million year-over-year. The company successfully financed $15 million to support clinical trials, including the Phase 1 study for PF614-MPAR™, aimed at reducing opioid overdose. Federal grant funding rose to $3.5 million, despite a slight overall decrease compared to 2020. Upcoming BE data is expected to bolster regulatory efforts for PF614.
Ensysce Biosciences (NASDAQ:ENSC) is set to release its fourth quarter and full year 2021 financial results on March 31, 2022. The company specializes in developing safer prescription drugs through innovative technology platforms, focusing on reducing drug abuse and overdose. Following the earnings release, Ensysce will host a corporate update call on April 6, 2022, at 11:00 a.m. ET. This session will offer insights into the company's progress, with a chance for participant Q&A.
Ensysce Biosciences (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company focused on developing safer prescription drugs, announced its participation in the 34th Annual Roth Conference from March 13-15, 2022. CEO Lynn Kirkpatrick and CFO Dave Humphrey will be available for meetings with investors. The company leverages its novel technology platforms, including MPAR™, to create next-generation opioids aimed at reducing overdose risks and supporting those with severe pain. This focus is particularly relevant as drug overdose deaths reach record highs.
Ensysce Biosciences has announced the appointment of Lee Rauch to its board of directors. With nearly 40 years of experience in clinical development and company building, Rauch has previously served as CEO of Viridian Therapeutics and was a founding member of McKinsey & Co.'s International Pharmaceutical Practice. Dr. Bob Gower, Chairman of Ensysce, expressed enthusiasm for her leadership as the company progresses with its pipeline, focusing on safer prescription drugs and innovative opioid solutions to combat abuse and overdose.
Ensysce Biosciences has engaged MZ Group for a strategic investor relations program aimed at enhancing visibility in capital markets. The company focuses on developing safer opioid alternatives through its TAAP and MPAR technology platforms. Ensysce's lead product, PF614, has received FDA Fast-Track Designation, indicating potential for reduced regulatory risk and expedited market entry. The firm aims to address the opioid crisis with innovative drugs that combine abuse deterrence and anti-overdose features, meeting significant market demand.
Ensysce Biosciences announced the results of its special stockholder meeting on January 26, 2022. Key resolutions adopted include the issuance of common stock for convertible notes and warrant exercises, and the approval of the Amended and Restated 2021 Omnibus Incentive Plan. These developments are aimed at advancing Ensysce's efforts in creating safer prescription drugs through its proprietary technology platforms. The company focuses on developing tamper-proof opioids to combat pain and reduce the risk of abuse and overdose.
Ensysce Biosciences (NASDAQ: ENSC, OTC: ENSCW) has urged shareholders to vote at its special meeting on January 26, 2022. Key proposals include approving the issuance of shares linked to convertible notes and warrants, and an Amended and Restated 2021 Omnibus Incentive Plan. The Board recommends a 'FOR' vote on both proposals to comply with Nasdaq Listing Rules. The meeting will be virtual due to COVID-19, requiring prior registration to attend. Results will be reported in a Current Report on Form 8-K post-meeting.
Ensysce Biosciences has initiated the Bioequivalence (BE) study for its novel opioid, PF614, as a step towards FDA approval. This study will compare PF614 with OxyContin and aims to establish data supporting a 505(b)(2) regulatory path, allowing reference to existing safety data. Successful completion of this study is critical for PF614's market introduction, with results expected in the second quarter of 2022. The study builds on previous safety results and aims to demonstrate PF614's abuse protection features, enhancing prescription safety.
Ensysce Biosciences announced participation in the H.C. Wainwright BIOCONNECT Conference from January 10-13, 2022. CEO Lynn Kirkpatrick and CFO Dave Humphrey will engage in one-on-one meetings with investors. An on-demand presentation will be available on the company’s Investor Relations website starting January 10, 2022, at 7:00 am ET. Ensysce focuses on developing safer prescription drugs utilizing innovative technology platforms aimed at combating opioid abuse and overdose mortality.
Ensysce Biosciences has announced the successful completion of Part A of its Phase 1b clinical study PF614-102, assessing its novel opioid PF614 against OxyContin. All three dose levels were administered to healthy subjects with positive oversight from the Safety Review Committee. Following this, the study will progress to the Bioavailability/Bioequivalence stage, with results expected in Q2 2022. The trial aims to address the opioid crisis by developing a safer, abuse-deterrent treatment for severe pain. Preliminary pharmacokinetic data confirmed expected outcomes without adverse events.
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