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SAN DIEGO - Ensysce Biosciences Inc. (NASDAQ:ENSC), a micro-cap pharmaceutical company with a market capitalization of $2.63 million, has received a Notice of Allowance from the U.S. Patent and Trademark Office for a patent on a new opioid use disorder (OUD) treatment, the company announced today. According to InvestingPro data, the stock has seen significant price movement, currently trading at $1.87, down about 77% over the past year. The patent covers PF9001, a medication that employs the company’s TAAP™ and MPAR® technologies to reduce the risks associated with traditional methadone therapy, including overdose and cardiotoxicity.
PF9001 represents a new class of treatment for OUD, aiming to provide a safer and more tolerable option for patients. The medication has shown promise in reducing cardiotoxicity potential and delivering a prolonged effect with once-daily dosing. This advancement comes as a response to the limitations of methadone, a standard treatment for OUD that carries risks of cardiac side effects, respiratory depression, and overdose.
Dr. Richard Dart, Director of the Rocky Mountain Poison and Drug Center, noted the potential of MPAR technology applied to methadone analogs in saving lives by reducing overdose risks. Dr. Lynn Kirkpatrick, CEO of Ensysce, expressed that PF9001 is the culmination of extensive research aimed at providing safer OUD medications. The project has garnered support from the National Institute on Drug Abuse, highlighting its significance in the field. InvestingPro analysis shows the company’s revenue grew by 133% in the last twelve months, though it maintains a weak financial health score of 1.72.
Ensysce Biosciences is known for developing innovative solutions for severe pain relief that minimize the potential for abuse and overdose. The company’s TAAP™ and MPAR® platforms are integral to its mission of introducing tamper-proof treatment options that address severe pain without the heightened risk of medication abuse.
The recent patent allowance marks a significant milestone for Ensysce as it continues its clinical-stage efforts to improve treatment outcomes for OUD patients. However, it’s important to note that PF9001 is still in clinical development, and its safety and efficacy must be established in ongoing trials before it can receive regulatory approval and be commercialized. InvestingPro indicates the company holds more cash than debt and maintains a healthy current ratio of 2.42, potentially providing sufficient runway for its development programs. Investors can access detailed financial analysis and 12 additional ProTips about Ensysce through an InvestingPro subscription, with the next earnings report expected on May 12, 2025.
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In other recent news, Ensysce Biosciences has concluded Part 1 of its second clinical trial for PF614-MPAR, a novel opioid medication designed for severe pain relief with built-in overdose protection. The trial results indicated that the protected version of the drug released a lower maximum concentration of oxycodone compared to its unprotected counterpart, suggesting enhanced safety. The company is in ongoing discussions with the FDA regarding the drug’s development path and plans to proceed with further trial phases. Additionally, Ensysce Biosciences announced a correction to its Annual Report filing, addressing an omission related to its Registration Statements on Form S-3. The revised document has been filed with the SEC, ensuring compliance without affecting previously reported financial results. In a separate development, Ensysce has raised approximately $1.1 million through a stock sale involving a registered direct offering and a concurrent private placement. The proceeds will support the further development of its TAAP™ and MPAR® programs and provide working capital. H.C. Wainwright & Co. acted as the exclusive placement agent for this transaction.
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