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 company whose news flow centers on the development of next-generation pain and central nervous system therapeutics that incorporate built-in abuse and overdose protection. Company updates frequently highlight progress across its proprietary TAAP™ (Trypsin-Activated Abuse Protection) and MPAR® (Multi-Pill Abuse Resistance) platforms, which are designed to create tamper-resistant prodrugs and overdose-protected medications.
Investors and healthcare observers following ENSC news can expect regular coverage of clinical milestones for PF614, the company’s TAAP™ extended-release oxycodone analogue for moderate to severe pain, including pivotal Phase 3 trial activities and regulatory interactions with the U.S. Food and Drug Administration. News items also describe the evolution of PF614-MPAR, which combines PF614 with MPAR® overdose protection and is advancing under FDA Breakthrough Therapy designation with support from multi-year NIDA grants.
Beyond pain management, Ensysce news includes developments in its ADHD pipeline, such as patent notices for PF8026, an immediate-release amphetamine prodrug that uses TAAP™ and MPAR® technologies to address stimulant abuse and overdose risk. Updates on PF9001, the company’s lead opioid use disorder candidate supported by a HEAL grant, also appear in the company’s communications.
Additional ENSC news covers intellectual property achievements extending MPAR® patent protection, federal grant awards, symposium presentations at major pain conferences, and financing transactions such as preferred stock offerings and registered direct offerings disclosed via SEC filings and press releases. This news page aggregates these announcements so readers can track Ensysce’s clinical, regulatory, intellectual property, and capital markets developments in one place.
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.