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SAN DIEGO - Ensysce Biosciences, Inc. (NASDAQ:ENSC), a clinical-stage pharmaceutical company with a market capitalization of $10.44 million, has announced positive interim data from a clinical trial evaluating its drug candidate PF614-MPAR for overdose protection. The study, known as PF614-MPAR-102, tested a 100 mg dosage form and demonstrated significant overdose protection when subjects consumed a greater-than-prescribed dose. According to InvestingPro data, the company maintains a healthy financial position with more cash than debt and a strong current ratio of 3.24.
The trial compared the maximum blood concentration of oxycodone in subjects taking PF614-MPAR versus PF614 alone. Results showed a substantially lower concentration in those receiving the MPAR product, indicating overdose protection. No difference was observed in subjects taking a single 100 mg dose of PF614 or PF614-MPAR, and no unexpected adverse events were reported.
PF614-MPAR, which combines an immediate release solution with an extended release capsule, had previously received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) in 2024. The development of the drug has been supported by a $14 million award from the National Institute on Drug Abuse (NIDA).
The ongoing trial will proceed to evaluate potential food effects and repeat dosing over several days. This interim data will guide the company in finalizing the drug product for commercialization.
Dr. Bill Schmidt, Chief Medical (TASE:PMCN) Officer at Ensysce, highlighted the FDA's recognition of PF614-MPAR's unique overdose protection. Dr. Lynn Kirkpatrick, CEO of Ensysce, expressed optimism about the early data and the company's progress towards bringing this overdose-protected opioid to the market. The company has shown impressive revenue growth of 40.41% over the last twelve months, though InvestingPro analysis indicates it's not yet profitable. The stock has demonstrated strong momentum with an 11.73% return over the past week, reflecting investor interest in these developments. InvestingPro subscribers have access to 10+ additional key insights about ENSC's financial health and market position.
Ensysce specializes in developing tamper-proof treatments for pain that reduce the risk of drug abuse and overdose, using its proprietary TAAP™ and MPAR® platforms. The company aims to provide safer options for severe pain management and help prevent deaths from medication abuse. For investors seeking deeper analysis of biotechnology companies like Ensysce, InvestingPro offers comprehensive financial metrics, Fair Value assessments, and expert insights to make informed investment decisions.
This report is based on a press release statement from Ensysce Biosciences.
In other recent news, Ensysce Biosciences has announced a reverse stock split, consolidating every 15 shares of issued and outstanding common stock into one share. This move is part of the company's strategy to maintain its listing on The Nasdaq Capital Market. Additionally, Ensysce Biosciences has secured substantial funding, including a $5 million financing transaction and a $14 million grant from the National Institutes of Health, to bolster the development of its opioid products, PF614 and PF614-MPAR.
The company has submitted a Phase 3 Protocol for PF614 to the FDA and plans to submit a New Drug Application by 2026. Ensysce has also been granted a Nasdaq listing extension, meeting the equity requirement as per Listing Rule 5550(b)(1). Furthermore, the company has amended its bylaws to reduce the quorum requirement for stockholder meetings.
Continental Stock Transfer & Trust Company, Ensysce Biosciences' transfer agent, will manage the reverse stock split process. Stockholders holding shares through brokerage accounts will not need to take any action as the exchange of their shares will be handled by their broker. These are the recent developments in the company's operations.
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