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Oregon to Become the First State to Legally Roll Out Psilocybin

FN Media Group Presents Microsmallcap.com Market Commentary

 

New York, NY – April 28, 2022 – Oregon is set to become the first US state to market legal psilocybin, the psychoactive substance found in magic mushrooms. Authorities plan to greenlight a particular species of magic mushroom for therapeutic use in the state starting in 2023. The psychedelics sector, which started to gain steam in 2021, is showing signs of potentially strong growth according to a new report by Defiance ETFs. The report states that growth drivers such as legislative changes in favor of psychedelics, increased investment in the space, clinical trials reporting positive results, and the increased demand for psychedelic-based treatments, particularly for mental illness. Companies developing psychedelic-based treatments like Cybin Inc (NYSEAmerican:CYBN) (NEO:CYBN), Mind Medicine (MindMed) Inc (NASDAQ:MNMD) (NEO:MMED), Compass Pathways (NASDAQ:CMPS), Seelos Therapeutics (NASDAQ:SEEL) and Johnson & Johnson (NYSE:JNJ) could gain momentum as the market for these alternative therapies emerges.

 

Focused on progressing “Psychedelics to Therapeutics™”, Toronto-based Cybin Inc (NYSE:CYBN) (NEO:CYBN) has been hyper-focused on advancing clinical trials. The biopharmaceutical company is studying derivatives of psilocybin and DMT to develop the next generation of psychedelics to potentially treat major depressive disorder (MDD), alcohol use disorder (AUD) and anxiety.

 

On April 21, Cybin announced a partnership with Clinilabs Drug Development Corporation to complete the Phase 1/2a clinical trial of CYB003, a proprietary deuterated psilocybin analog. Clinilabs has deep expertise in central nervous system drug development. CYB003 will be the first psilocybin analog to be evaluated in Phase 1/2a development for the treatment of MDD.

 

“We are delighted to partner with the Clinilabs team as we progress this important program toward a first-in-human Phase 1/2a trial. Clinilabs brings a unique combination of scientific and operational experience and deep expertise in clinical research across a range of psychiatric, neurological and substance use disorders,” said Cybin’s CEO Doug Drysdale. “Clinilabs is ideally suited to help us accelerate the regulatory pathway for this promising treatment candidate and ultimately, to effectively treat those suffering with MDD.”

 

CYB003 demonstrated significant advantages over conventional psilocybin in multi-species preclinical studies. Cybin plans to submit an IND to the FDA in the second quarter of 2022 and to start the Phase 1/2a trial in mid-2022.

 

Earlier in April, Cybin announced positive preclinical data from a pharmacokinetic study evaluating its proprietary deuterated dimethyltryptamine (DMT) molecule, CYB004, administered by inhalation. Inhaled CYB004 demonstrated significant advantages over intravenous and inhaled DMT, such as improved bioavailability and longer duration of action. Cybin is currently developing CYB004 for the treatment of anxiety disorders.

 

The company plans to file a regulatory filing for a pilot study in the second quarter of 2022 and to start the pilot study in the third quarter of the same year.

 

For more information about Cybin Inc (NYSE:CYBN) (NEO:CYBN), click here.

 

Biopharma Companies Are Advancing Studies on Psychedelics

 

Mind Medicine (MindMed) Inc (NASDAQ:MNMD) (NEO:MMED), a clinical-stage biopharmaceutical company developing new products to treat brain health disorders, announced on April 14 that Dr. Friederike Holze and Prof. Dr. Matthias Liechti, MindMed collaborators at University Hospital Basel (UHB), will present the results of the LSD-Assist study, an investigator-initiated Phase 2 clinical trial of LSD in the treatment of anxiety disorders, at the PSYCH Symposium in London on May 11, 2022. The presentation will present key preliminary safety and efficacy results of LSD in 46 patients with clinically significant anxiety. MindMed recently appointed François Lilienthal, MD, as Chief Commercial Officer. With more than 20 years of global biopharmaceutical experience and having served as a consultant to MindMed for the past six months, Dr. Lilienthal will assume this role to support the advancement of the company’s clinical development programs.

 

Compass Pathways (NASDAQ:CMPS), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, just announced a partnership with One Mind, a nonprofit research organization in leading California-based mental health, to sponsor three “2022 One Mind – COMPASS Rising Star Awards”. The One Mind Rising Star Awards are given annually to promising early career researchers who are pursuing research that has the potential to significantly advance the understanding and treatment of mental illness and improve patient outcomes. Up to three winners will be announced in September 2022 and will receive a Compass-sponsored $300,000 research grant over three years.

 

Johnson & Johnson (NYSE:JNJ) paved the way for psychedelic medicine’s mainstream approval with SPRAVATO®, an esketamine nasal spray taken with an oral antidepressant for adults with treatment-resistant depression and major depressive disorder (MDD) and the first FDA-approved psychedelic treatment. Last February, Johnson & Johnson announced that the European Union authorized the expanded use of SPRAVATO, co-administered with oral antidepressant therapy for adults experiencing a moderate to severe episode of MDD, as acute short-term treatment, for the rapid reduction of depressive symptoms, which according to clinical judgment constitute a psychiatric emergency.

 

Seelos Therapeutics (NASDAQ:SEEL), a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders and rare diseases, has received an acknowledgment letter of a Clinical Trial Notification from the Australian Government Department of Health Therapeutics Goods Administration for a pilot study of SLS-005 to treat patients with Alzheimer’s disease. Seelos has also received the authorization to conduct a separate open-label basket study in Australia to assess the efficacy, safety, and tolerability of SLS-005 on disease progression and severity in participants with selected neurodegenerative diseases, including Huntington’s disease. On April 11, Seelos announced an amendment to the agreement with Phoenix AG for the development of SLS-002 (Intranasal Racemic Ketamine Program) to repurchase the remaining royalties payable on any future net sales of SLS-002 in stock and cash, all future successes, business milestones and change of control fees if SLS-002 is acquired.

 

Doug Drysdale, Cybin’s Chief Executive Officer, presented at the KCSA Psychedelics Virtual Investor Conference on April 28, 2022. The webcast is available on the company’s investor relations website on the Events & Presentations page.

 

DISCLAIMER: Microsmallcap.com (MSC) is the source of the Article and content set forth above.  References to any issuer other than the profiled issuer are intended solely to identify industry participants and do not constitute an endorsement of any issuer and do not constitute a comparison to the profiled issuer. FN Media Group (FNM) is a third-party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated with MSC or any company mentioned herein. The commentary, views and opinions expressed in this release by MSC are solely those of MSC and are not shared by and do not reflect in any manner the views or opinions of FNM. Readers of this Article and content agree that they cannot and will not seek to hold liable MSC and FNM for any investment decisions by their readers or subscribers. MSC and FNM and their respective affiliated companies are a news dissemination and financial marketing solutions provider and are NOT registered broker-dealers/analysts/investment advisers, hold no investment licenses and may NOT sell, offer to sell or offer to buy any security.

 

The Article and content related to the profiled company represent the personal and subjective views of the Author (MSC), and are subject to change at any time without notice. The information provided in the Article and the content has been obtained from sources which the Author believes to be reliable. However, the Author (MSC) has not independently verified or otherwise investigated all such information. None of the Author, MSC, FNM, or any of their respective affiliates, guarantee the accuracy or completeness of any such information. This Article and content are not, and should not be regarded as investment advice or as a recommendation regarding any particular security or course of action; readers are strongly urged to speak with their own investment advisor and review all of the profiled issuer’s filings made with the Securities and Exchange Commission before making any investment decisions and should understand the risks associated with an investment in the profiled issuer’s securities, including, but not limited to, the complete loss of your investment. FNM was not compensated by any public company mentioned herein to disseminate this press release but was compensated twenty five hundred dollars by MSC, a non-affiliated third party to distribute this release on behalf of Cybin Inc

 

FNM HOLDS NO SHARES OF ANY COMPANY NAMED IN THIS RELEASE.

 

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected,” “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and MSC and FNM undertake no obligation to update such statements.

 

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Source: Microsmallcap.com

The post Oregon to Become the First State to Legally Roll Out Psilocybin appeared first on Financial News Media.

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