Mydecine Innovations Group (MYCOF) Submits Pre-Investigational New Drug Briefing Package to the FDA for MYCO-001

The biotech sector is also presenting exciting opportunities for investors. Many of the best biotech companies have both strong drug candidate pipelines and winning drugs already on the market. The COVID-19 pandemic has also created massive opportunities for biotechnology companies.

According to the Centers for Disease Control and Prevention (CDC), cigarette smoking is responsible for one out of every five deaths in the United States, roughly 480,000 people every year. Approximately 34.1 million Americans currently smoke cigarettes. About 68% have stated they would like to quit smoking, and 55% have made an attempt to quit, yet only 7.5% are successful (1).

Earlier this month, Mydecine Innovations Group (OTC US: MYCOF) (FSE: 0NFA), a biotechnology and digital technology company aiming to transform the treatment of mental health and addiction disorders announced in preparation for its FDA pre-Investigational New Drug (IND) meeting on February 28th, the company has submitted a pre-IND briefing package to the U.S. Food and Drug Administration (FDA) for a clinical study evaluating MYCO-001 in a structured smoking cessation treatment program (1).

“Even with a wide variety of approved treatments on the market, tobacco addiction continues to remain largely untreated,” added Mydecine CMO Dr. Rakesh Jetly. “With safety and efficacy concerns about current therapies, including the recall of the blockbuster treatment Chantix, there is a strong need for innovative and improved treatment options.” (1).

Earlier, in Jan 2022, Mydecine Innovations Group (NEO: MYCO) (OTC:MYCOF) (FSE:0NFA) had also announced a partnership with Combat Stress (Combat Stress) and the King’s College London to utilize psilocybin as part of psychoactive-assisted psychotherapy treatment for post-traumatic stress disorder (PTSD) in veterans. Combat Stress will be one of several sites for Mydecine’s upcoming clinical trials (2).

MYCOF is tradig at mere 14 cents and seems highly undervalued. 

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Mydecine Innovations Group™ (NEO:MYCO) (OTC:MYCOF) (FSE:0NFA) is a biotechnology and digital technology company developing innovative first- and-second-generation novel therapeutics for the treatment of mental health and addiction using world-class technology and drug development infrastructure. Mydecine was founded in 2020 to address a significant unmet need and lack of innovation in the mental health and therapeutic treatment environments. Our global team is dedicated to efficiently developing new therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. The Mydecine business model combines clinical trials and data outcome, technology, and scientific and regulatory expertise with a focus on psychedelic therapy, as well as other novel, non-psychedelic molecules with therapeutic potential. By collaborating with some of the world’s foremost authorities, Mydecine aims to responsibly fast-track the development of new medicines to provide patients suffering from mental health disorders with safe and more effective treatment options. Mydecine Innovations Group is headquartered in Denver, Colorado, USA, with international offices in Leiden, Netherlands.

Some other biotech stocks to place on radar would be Axsome Therapeutics (NASDAQ:AXSM), Theravance Biopharma (NASDAQ:TBPH), GH Research (NASDAQ:GHRS), CinCor Pharma (NASDAQ:CINC), Sundial Growers (NASDAQ:SNDL) and Reata Pharmaceuticals (NASDAQ:RETA). As alwasy, conduct your own due diligence.

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