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 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.
Ensysce Biosciences (NASDAQ:ENSC) issued its 2023 shareholder letter, highlighting significant progress in clinical programs aimed at combating opioid abuse and overdose. The company reported positive clinical results and is advancing its lead product, PF614, through various studies. Ensysce's technology platforms, TAAP and MPAR, are designed to enhance drug safety while addressing the opioid crisis. Financially, the company secured $8 million via convertible notes and closed a $4.1 million public offering. Future clinical data is expected in early 2023, reinforcing Ensysce's commitment to improving prescription drug safety.
Ensysce Biosciences (NASDAQ:ENSC, OTC:ENSCW) announced the successful completion of its clinical study PF614-104, aimed at evaluating the oral abuse potential of PF614 compared to oxycodone. This study contributes to FDA abuse-deterrent labeling efforts. The trial involved 32 recreational drug users, assessing measures like 'drug liking.' Results are expected by March 2023. PF614 is designed to resist misuse, providing safer pain management. The company emphasizes its commitment to addressing opioid abuse while offering effective treatment alternatives.
Ensysce Biosciences has reported promising results from its clinical study of PF614-MPAR, aimed at providing overdose protection for opioid pain relief. Conducted by Dr. Maria Bermudez, the trial demonstrated that the product limits oxycodone release in cases of deliberate or accidental overdose due to its unique formulation with nafamostat. The study achieved its goal by showing comparable oxycodone delivery and exhibited reduced oxycodone uptake with higher doses of PF614-MPAR. Ensysce plans to further evaluate the product in early 2023, emphasizing its potential to save lives.
Ensysce Biosciences has priced an underwritten public offering of 2,900,000 shares of common stock and warrants to purchase up to 5,800,000 shares at an effective price of $1.40 per share. The offering is expected to yield gross proceeds of approximately $4.1 million, closing on or around December 9, 2022. Funds will be allocated as follows: 20% for repaying convertible notes and the remainder for clinical developments and working capital. Lake Street Capital Markets is the sole underwriter. A prospectus related to the offering has been filed with the SEC.
Ensysce Biosciences has completed the clinical portion of study PF614-MPAR-101 Part A, focusing on its innovative pain management product designed to reduce opioid overdose risk. The study evaluated the pharmacokinetics of oxycodone and PF614, alongside nafamostat, in healthy subjects. CEO Lynn Kirkpatrick emphasized the urgency of addressing opioid overdoses, revealing plans for further study in 2023 to enhance overdose protection. Ensysce's MPAR technology aims to mitigate abuse through a unique combination of a prodrug and a trypsin inhibitor, potentially revolutionizing treatment for severe pain.
Ensysce Biosciences, a clinical-stage biotech firm, reported Q3 2022 financials highlighting a net loss of $9.9 million, a decrease from $17.2 million year-over-year. Cash reserves stood at $4.5 million, up from $3.7 million in the previous quarter. The CEO noted positive topline results from the human abuse potential study of PF614, indicating its advantages over existing products. Furthermore, the FDA provided guidance supporting PF614's development for acute pain. R&D expenses surged to $4.8 million, reflecting ongoing clinical activities.
Ensysce Biosciences (NASDAQ:ENSC) announced receiving FDA guidance regarding its lead product, PF614, indicating that pursuing an acute pain indication is advisable. The FDA's non-binding guidance suggests conducting two clinical trials comparing PF614 with a placebo and an immediate-release opioid like oxycodone. This strategy may reduce the development timeline and costs, compared to a chronic pain focus. Ensysce plans to advance PF614 for acute pain while continuing chronic pain development, aiming to complete human abuse potential studies and initiate Phase 3 trials in the upcoming year.
Ensysce Biosciences has announced positive topline results from a human abuse potential (HAP) study of PF614, an innovative oxycodone product designed to deter abuse. The study demonstrated that PF614 resulted in significantly lower peak 'drug liking' compared to traditional oxycodone. This is crucial for its FDA approval process, aligning with the agency's guidance on evaluating abuse potential. The company is committed to advancing this product into Phase 3 studies, addressing a significant need for safer analgesics in chronic pain management.
FAQ
What is the current stock price of Ensysce Biosciences (ENSC)?
What is the market cap of Ensysce Biosciences (ENSC)?
What is Ensysce Biosciences, Inc.?
What technologies does Ensysce use in its drug development?
What are the core products in Ensysce’s development pipeline?
What recent achievements have Ensysce made?
What is the significance of FDA Breakthrough Therapy designation?
How is Ensysce addressing the opioid epidemic?
What financial strategies support Ensysce’s operations?
What partnerships has Ensysce formed to advance its drug development?
What future projects is Ensysce Biosciences involved in?
Where can more information about Ensysce Biosciences be found?
