BioMedNewsBreaks – Mydecine Innovations Group (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA) Announces Positive Pre-IND Meeting with FDA for Smoking Cessation Study

Mydecine Innovations (NEO: MYCO) (OTC: MYCOF) (FSE: 0NFA), a biotechnology company aiming to transform the treatment of mental health and addiction disorders, today announced a positive meeting with the Food and Drug Administration (“FDA”) regarding the company’s Investigational New Drug (“IND”) and breakthrough therapy status applications. During the meeting, Mydecine reviewed its IND application to administer MYCO-001, in combination with therapy, to humans as part of smoking cessation treatment. Dr. Matthew Johnson of Johns Hopkins University, a leading researcher of drug and substance abuse, will serve as the lead investigator for the multisite study. “The data from John Hopkins University’s ongoing studies assessing psychedelic-assisted therapy to treat nicotine addiction is showing efficacy rates two to three times higher than the current gold standard of treatment,” said Mydecine Chief Medical Officer Dr. Rakesh Jetly. “Our team is eager to start collecting the data needed to bring an approved drug product to market that could potentially save millions of lives.”

To view the full press release, visit https://ibn.fm/kFqFL

About Mydecine Innovations Group

Mydecine is a biotechnology and digital technology company developing innovative first-and-second-generation novel therapeutics for the treatment of mental health and addiction through 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. The company’s global team is dedicated to efficiently developing innovative therapeutics to treat PTSD, depression, anxiety, addiction and other mental health disorders. Mydecine’s business model combines clinical trials and data outcome, technology, 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. For more information about the company, please visit www.Mydecine.com.

NOTE TO INVESTORS: The latest news and updates relating to MYCOF are available in the company’s newsroom at https://ibn.fm/MYCOF

About BioMedWire

BioMedWire (BMW) is an information service that provides (1) access to our news aggregation and syndication servers, (2) BioMedNewsBreaks that summarize corporate news and information, (3) enhanced press release services, (4) social media distribution and optimization services, and (5) a full array of corporate communication solutions. As a multifaceted financial news and content distribution company with an extensive team of contributing journalists and writers, BMW is uniquely positioned to best serve private and public companies that desire to reach a wide audience of investors, consumers, journalists and the general public. BMW has an ever-growing distribution network of more than 5,000 key syndication outlets across the country. By cutting through the overload of information in today’s market, BMW brings its clients unparalleled visibility, recognition and brand awareness. BMW is where news, content and information converge.

To receive SMS text alerts from BioMedWire, text “STOCKS” to 77948 (U.S. Mobile Phones Only)

For more information please visit https://www.biomedwire.com

Please see full terms of use and disclaimers on the BioMedWire website applicable to all content provided by BMW, wherever published or re-published: http://BMW.fm/Disclaimer

BioMedWire (BMW)
San Francisco, California
www.biomedwire.com
415.949.5050 Office
Editor@BioMedWire.com

BioMedWire is part of the InvestorBrandNetwork

Chris@BMW

Share
Published by
Chris@BMW

Recent Posts

BioMedNewsBreaks — Cardio Diagnostics Holdings Inc. (NASDAQ: CDIO) Targets Precision Cardiology with Multi-Omic AI Platform

Cardio Diagnostics Holdings (NASDAQ: CDIO) is positioned for opportunity as cardiovascular diagnostics are undergoing a transformation as…

15 hours ago

BioMedNewsBreaks – Telomir Pharmaceuticals (NASDAQ: TELO) Receives FDA IND Clearance for Telomir-Zn in Triple-Negative Breast Cancer

Telomir Pharmaceuticals (NASDAQ: TELO), a clinical-stage biotechnology company, announced that the U.S. Food and Drug…

19 hours ago

BioMedNewsBreaks – Oncotelic Therapeutics, Inc. (OTCQB: OTLC) Advances AI and Robotics Platform Toward Initial Commercial Deployment

Oncotelic Therapeutics (OTCQB: OTLC), a clinical-stage biotechnology company, reported continued progress on its proprietary AI…

19 hours ago

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) to Host Q1 2026 Earnings Call and Provide Strategic Updates

HeartBeam (NASDAQ: BEAT), a medical technology company focused on cardiac care innovation, will host a…

20 hours ago

BioMedNewsBreaks — Earth Science Tech Inc. (ETST) Leveraging Vertical Integration to Target Precision Medicine Market

Earth Science Tech (OTC: ETST) was featured in a recent article that discussed its efforts to…

2 days ago

BioMedNewsBreaks – MindBio Therapeutics Corp. (CSE: MBIO; Frankfurt: WF6; OTCQB: MBQIF) Files Patent Applications for AI Voice Intoxication Detection Technology

This article has been disseminated on behalf of MindBio Therapeutics Corp. and may include paid…

2 days ago