MIAMI - MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA), a pre-clinical stage pharmaceutical company, received a favorable ruling from the U.S. Drug Enforcement Administration (DEA) regarding its investigational drug MIRA-55, clearing it from being classified as a controlled substance.
This decision, announced today, is pivotal for the company as it aims to advance the development of MIRA-55, which is being studied for the treatment of neuropathic pain, anxiety, and cognitive decline associated with early-stage dementia.
MIRA-55 has shown promise in pre-clinical studies, demonstrating the potential to enhance memory and cognitive performance. The drug's profile contrasts with the effects of marijuana, specifically THC, which can impair cognitive function. The DEA's ruling signifies a regulatory advantage for MIRA-55 over marijuana, which is still classified as a Scheduled drug, as it simplifies research and development processes by reducing legal and logistical barriers.
Erez Aminov, Chairman & CEO of MIRA Pharmaceuticals, expressed enthusiasm about the DEA's decision, highlighting MIRA-55's unique cognitive and anxiety benefits. The ruling is seen as an opportunity for MIRA Pharmaceuticals to tap into the traditional neurological and cannabis markets, which are valued at $90 billion and $30 billion, respectively.
Dr. Itzchak Angel, Chief Scientific Advisor of MIRA Pharmaceuticals, noted the high prevalence of anxiety disorders and cognitive impairment in the U.S., and the limitations of current treatments. MIRA-55 is positioned as a potential alternative offering quicker relief with fewer side effects.
MIRA Pharmaceuticals is also developing Ketamir-2, another investigational drug not considered a controlled substance by the DEA. Ketamir-2 is an oral ketamine analog being evaluated for ultra-rapid antidepressant effects in treatment-resistant depression and other conditions.
It is important to note that both MIRA-55 and Ketamir-2 are in early-stage preclinical development, and there is no assurance that they will proceed through development or receive FDA approval for marketing. The information in this article is based on a press release statement from MIRA Pharmaceuticals.
InvestingPro Insights
As MIRA Pharmaceuticals celebrates the favorable DEA ruling for its investigational drug MIRA-55, investors may be looking at the financial health of the company to gauge its ability to capitalize on this regulatory advantage. According to InvestingPro data, MIRA Pharmaceuticals has a market capitalization of $12.57 million, reflecting the current valuation of the company in the market.
An important metric to consider is the company's price to earnings (P/E) ratio, which currently stands at -1.09. This negative P/E ratio, which has adjusted slightly to -1.02 over the last twelve months as of Q1 2024, indicates that the company is not profitable at this time. This is further underscored by the company's return on assets, which was -587.64% for the same period, pointing to challenges in generating profit from its assets.
Despite these challenges, one of the InvestingPro Tips highlights that MIRA Pharmaceuticals holds more cash than debt on its balance sheet, which could provide some financial flexibility as it continues to develop its product pipeline.
Moreover, the company's liquid assets exceed its short-term obligations, suggesting a degree of financial stability in the near term. Investors should note that the stock has experienced a significant price decline over the last year, with a -88.54% one-year price total return as of the specified date in 2024.
For investors seeking a more comprehensive analysis of MIRA Pharmaceuticals, additional InvestingPro Tips are available on the platform, including insights into the company's gross profit margins and dividend policy. To access these tips and more, visit https://www.investing.com/pro/MIRA and consider using the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription. In total, there are 7 InvestingPro Tips available for MIRA Pharmaceuticals, which could help investors make more informed decisions.
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