Ensysce Biosciences Inc Stock Price, News & Analysis

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.

Ensysce Biosciences has enrolled its first patients in a Phase 1 clinical study for PF614-MPAR, designed to provide safety and pharmacokinetics data. This product combines PF614, a trypsin-activated oxycodone prodrug, with nafamostat to offer abuse and overdose protection. Dr. Lynn Kirkpatrick highlighted the urgent need to address opioid abuse and overdose deaths, aiming for safer pain management solutions. The clinical trial is seen as a crucial step toward the development of this innovative product, potentially paving the way for future trials.

Ensysce Biosciences has completed a positive safety review for its PF614 opioid study, advancing to the highest dose cohort. The Phase 1b study will evaluate dosing safety and pharmacokinetics compared to OxyContin, with results expected in early 2022. PF614 aims to provide enhanced pain relief while minimizing abuse potential through its Trypsin Activated Abuse Protection technology. The company has bolstered its management team, achieved significant milestones, and secured funding for further clinical initiatives, positioning itself for continued success in the opioid market.