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 announced Dr. Lynn Kirkpatrick's participation as a speaker at a seminar on March 22, 2023, in New York, highlighting the company's collaboration with Quotient Sciences. The seminar, part of DCAT Week, will showcase how the partnership has accelerated the development of Ensysce's overdose protection program, PF614-MPAR, which aims to combat opioid abuse. This unique platform integrates both abuse deterrence and overdose protection, potentially saving lives. The integration is facilitated by Quotient's Translational Pharmaceutics program, allowing real-time drug product evaluation.
Ensysce Biosciences (NASDAQ:ENSC) has locked its database for the oral Human Abuse Potential (HAP) study of PF614, a controlled-release oxycodone product, on February 24, 2023. This pivotal study is essential for obtaining Abuse Deterrent labeling from the FDA. Following unblinding on February 27, 2023, results are scheduled for release by the end of March 2023. The company leverages its Trypsin Activated Abuse Protection (TAAP) technology to develop safer pain management options that mitigate risks of abuse and overdose.
Ensysce Biosciences (NASDAQ: ENSC), a clinical-stage biotech company, issued a letter from CEO Dr. Lynn Kirkpatrick addressing shareholder questions. The company aims to improve drug safety, specifically focusing on opioid analgesics to combat the opioid crisis. Ensysce's unique technology chemically modifies opioids to reduce abuse potential. In 2022, the company initiated four clinical studies, achieving positive results in three, with expectations for upcoming data on the fourth study.
As of September 30, 2022, Ensysce had $4.5 million in cash and has taken measures to manage potential dilution and cash burn while advancing its clinical programs.
Ensysce Biosciences (NASDAQ:ENSC), a clinical-stage biotech company, announced on February 14, 2023, that the Nasdaq Hearings Panel granted its request for continued listing on the Nasdaq Stock Market. This decision is contingent on the company meeting criteria for the Nasdaq Capital Market tier, including a minimum bid price of $1.00 and stockholders' equity of at least $2.5 million by June 12, 2023. Ensysce focuses on innovative drug safety technologies to combat prescription medication abuse and overdoses through its proprietary platforms, TAAP and MPAR.
Ensysce Biosciences (NASDAQ:ENSC) announced that Geoff Birkett, Chief Commercial Officer, will present at the Annual NIH HEAL Meeting on February 22, 2023, in Washington, D.C. The HEAL initiative focuses on improving treatment strategies for opioid misuse and enhancing pain management. Ensysce will showcase its MPARTM platform, which includes PF614-MPAR, the first opioid with both abuse deterrent and overdose protection properties. Dr. Lynn Kirkpatrick emphasized the significance of federal support in advancing their mission to combat opioid abuse and potentially save lives.
Ensysce Biosciences (NASDAQ:ENSC) announced the closure of a registered direct offering, selling 3,571,431 shares at $0.84 per share, generating approximately $3.0 million in gross proceeds. A concurrent private placement involved issuing warrants for the same number of shares with an exercise price of $0.715, which are immediately exercisable.
The proceeds are intended for general corporate purposes including capital expenditures, working capital, and debt repayment. The shares were offered under a previously filed effective registration statement with the SEC, which also included a prospectus for investors.
Ensysce Biosciences, Inc. (NASDAQ:ENSC) announced a registered direct offering of 3,571,431 shares of common stock at $0.84 per share, totaling approximately $3 million in gross proceeds. Concurrently, the company will issue warrants for 3,571,431 shares with an exercise price of $0.715, exercisable immediately for five and a half years. The offering is expected to close around February 6, 2023, pending standard conditions. Proceeds will be utilized for corporate purposes, including capital expenditures, working capital, and debt repayment. H.C. Wainwright & Co. serves as the exclusive placement agent for this transaction.
Ensysce Biosciences has declared a dividend of 0.001 of a share of newly-designated Series A Preferred Stock for each outstanding share of common stock as of February 13, 2023. The Series A Preferred Stock will carry voting rights related to a reverse stock split and other specific matters. Each share will have 1,000,000 votes per share and will be automatically redeemed if not present at the stockholders' meeting. Ensysce is focused on developing safer prescription drugs using its proprietary technologies to minimize abuse and overdose risks. Detailed information about the Series A Preferred Stock will be released in upcoming SEC filings.
Ensysce Biosciences announces the initiation of the final stage of a Phase 1 study for PF614-MPAR, an innovative opioid with overdose protection features, aimed at enhancing pain management while reducing abuse risks. Conducted by Dr. Maria Bermudez at Quotient Sciences in Miami, this trial follows successful initial testing, demonstrating that PF614-MPAR can limit oxycodone release during overdose. With its dual safety mechanisms, PF614-MPAR is expected to address common abuse methods. CEO Lynn Kirkpatrick emphasizes the potential to revolutionize pain treatment with this breakthrough, targeting severely afflicted patients.
Ensysce Biosciences announced that CEO, Dr. Lynn Kirkpatrick, will present at the Diamond Equity Research 2023 Virtual Emerging Growth Invitational on January 25, 2023, at 12:20 p.m. Eastern Time. Ensysce, operating under the ticker symbols ENSC and ENSCW, is a clinical-stage biotech company developing tamper-proof prescription drugs to reduce abuse and overdose risk. The presentation will be followed by a Q&A session, and a live webcast will be available. Ensysce utilizes proprietary platforms, such as TAAP and MPAR, to create safer treatment options for severe pain.