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 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.
Ensysce Biosciences (NASDAQ: ENSC) reported its Q3 2021 financial results on November 15, 2021. The company completed a $15 million convertible note financing, enhancing its cash position to $6.8 million pre-financing. Key highlights include an increase in federal grants to $1.2 million and a rise in R&D expenses to $1.7 million due to clinical activities related to PF614. However, the company reported a net loss of $17.2 million, contrasting with a net income of $1.6 million in Q3 2020. Ensysce continues to develop opioid abuse deterrents and appointed Dr. Linda Pestano as Chief Development Officer.
Ensysce Biosciences has successfully completed a private placement for $15 million through senior secured convertible notes and warrants. The latest funding round closed on November 5, 2021, with $10 million raised. The convertible notes have a conversion price of $5.87, and the accompanying warrants allow for the purchase of common stock at $7.63. Funds will support the advancement of clinical trial programs, including critical studies related to opioid abuse prevention. This financing strengthens Ensysce's commitment to developing safer prescription drugs.
Ensysce Biosciences has appointed Linda Pestano, PhD, as Chief Development Officer effective October 15, 2021. Dr. Pestano brings over 20 years of experience in drug development and has worked on therapies for various indications. CEO Dr. Lynn Kirkpatrick highlighted her expertise as a boon for advancing their opioid products and addressing concerns in the opioid crisis. Ensysce is focused on developing safer prescription drugs through its proprietary platforms aimed at reducing abuse and overdose.
Ensysce Biosciences has secured a $15 million investment through a securities purchase agreement involving senior secured convertible notes and warrants. The initial $5 million was funded on September 24, 2021. The notes, convertible at $5.87, mature in 21 months, bearing 5% interest. Proceeds will support clinical programs, including studies on opioid treatment. CEO Dr. Lynn Kirkpatrick highlighted this financing as essential for combating the opioid crisis.
Ensysce Biosciences has commenced a second clinical study of PF614, a trypsin-activated opioid designed to deter abuse, with the first cohort enrolled on September 7, 2021. This Phase 1b trial will evaluate PF614's pharmacokinetics and safety, comparing it to OxyContin. The study aims to advance understanding of PF614's potential as a safer pain management option, contributing to solutions for the opioid crisis. Ensysce's innovative approach aligns with pressing healthcare needs, focusing on effective treatments for chronic pain while minimizing abuse risks.
FAQ
What is the current stock price of Ensysce Biosciences (ENSC)?
What is the market cap of Ensysce Biosciences (ENSC)?
