The Next Great Biotech Boom Has Arrived

FN Media Group Presents Market Commentary


London – March 19, 2024 – The U.S. Federal Drug Administration (FDA) has now designated psilocybin, a classical compound found in “magic mushrooms,” as a “breakthrough therapy” for the treatment of major depressive disorder three times.  And the world’s largest clinical trial ever into the use of psilocybin for treating depression at London hospital in what scientists are hailing as a “milestone” in mental health research.   Mentioned in today’s commentary includes:  Johnson & Johnson (NYSE: JNJ), COMPASS Pathways plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), Atai Life Sciences N.V. (NASDAQ: ATAI), AbbVie Inc. (NYSE: ABBV).


This new frontier in treatment has kickstarted a multi-trillion-dollar industry geared at fixing the brain through therapy.


Johnson and Johnson has gone all in on its fastest-growing drug for depression, SPRAVATO, which is the only FDA-approved psychedelic medicine on the market. In its Q4 2023 earnings released in January, JNJ reported a 74.1% increase in sales of SPRAVATO worldwide and views the drug as its next billion-plus product.


And some of the core team members behind the development of the SPRAVATO have now joined a small, but emerging NYSEAmerican-listed company, CYBIN (CYBN, CYBN.NE).


CYBIN has now been granted “Breakthrough Therapy Designation”, and is the first adjunctive psychedelic-based therapy for Major Depressive Disorder (MDD) ever to receive this FDA designation.


Oppenheimer initiated coverage on CYBN last year, saying it was encouraged by the results so far and believed the stock would have room to run further with new results. It has a price target of $4.


H.C.Wainwright & Co. took it further, with a price target of US $10.00 per share, after the recent Small Pharma acquisition.


But with impressive Phase 2 results showing remission after only two doses and a coveted FDA designation, this small company is now poised for much greater attention from investors.


Phase 2: Behind the Breakthrough Therapy Designation


CYBIN is developing differentiated, next-generation therapeutics that hope to offer fast, sustained therapeutic effects that are safe and tolerable, with efficacy in only 1-2 doses and short in-clinic times.


The company is on the leading edge of transformational psychedelic therapeutics, developing novel and proprietary therapeutics to improve clinical outcomes and patients’ mental health and well-being. The emerging biopharmaceutical company already has clinical validation of the novel, proprietary CYB003 molecule, which demonstrates a rapid-acting and robust psychedelic profile at a low dose. And it’s been pounding the patent pavement, too.


In August, CYBIN agreed to acquire Small Pharma Inc in an all-share transaction that creates an international clinical-stage leader in novel psychedelic therapeutics. The companies’ combined portfolios, at closing, will include two proprietary, advanced clinical programs in development for depression and anxiety disorders with demonstrated safety and efficacy. The combined portfolio creates the industry’s largest, most advanced, well protected DMT program.


The combined company has the intellectual property strength of 29 patents granted and 158 patents pending in the psychedelic drug development sector. That is the largest portfolio in the industry.


Phase 2 topline efficacy data for the company’s CYBOO3 was one of the biggest drivers of value for CYBIN in the near-term, and the results were even better than expected.


Now that it’s been granted “Breakthrough Therapy Designation”, CYBIN is targeting the potential for its CYB003 to achieve “Best-in-Class Status”, and it’s confident it has a solid shot at this.


In targeting depression, CYBIN’s CYB003 is hoping to offer a lifeline to a chronic illness that victimizes some 280 million people around the world. They are also targeting what is now recognized as the leading cause of disability in the world, which costs the global economy an estimated $1 trillion in lost productivity annually.


Nowhere But Up: The Next Near-Term Catalysts


CYBIN plans to initiate its Phase 3 study of CYBOO3 in MDD in the middle of this year, with the Phase 2 study of CYB004 in Generalized Anxiety Disorder (GAD) launched on March 15.


For the Phase 2 proof-of-concept study of CYB004, CYBIN is using its proprietary DMT molecule, which was developed for the treatment of GAD, following the FDA’s clearance of its new drug application in January.


“We are building on foundational investigative work from our Phase 2a trial of intravenous SPL026 (DMT) which showed preliminary evidence of effectiveness treating anxiety with rapid onset of antidepressant effects and reduction in anxiety scores,” Drysdale said in a press release.


“The molecular structure of psilocybin, a naturally occurring psychedelic compound found in ‘magic mushrooms,’ allows it to penetrate the central nervous system and the scientific and medical experts are just beginning to understand its effects on the brain and mind and its potential as therapeutics for mental illnesses,” according to Johns Hopkins Center for Psychedelic and Consciousness Research.   This is a space where proprietary IP is absolutely essential, and Cybin now has 29 patents granted and 158 patents pending.


CYBIN (CYBN, CYBN.NE) is a clear leader in the biotech race for an alternative to the antidepressant empire, and now it has breakthrough therapy status, and is the first adjunctive therapy known to achieve this for massive depressive disorder.


Big Pharma is Racing for a Piece of the Pie


Johnson & Johnson (JNJ) is a global leader in healthcare, with a diverse portfolio that spans pharmaceuticals, medical devices, and consumer health products. Within this vast array, Janssen, its pharmaceutical branch, has made significant strides in mental health with esketamine, marketed as Spravato. This nasal spray, a derivative of the anesthetic ketamine, represents a significant breakthrough, gaining FDA approval for use in treatment-resistant depression. The approval of Spravato underscores J&J’s commitment to addressing complex mental health challenges.


AbbVie (ABBV) emerged as a standalone biopharmaceutical entity following its split from Abbott Laboratories in 2013. Focused on discovering treatments for a wide range of diseases, including rheumatoid arthritis and various cancers, AbbVie’s acquisition of Allergan expanded its reach into the burgeoning field of psychedelics for mental health. Allergan, known for its pioneering work in this area, has enriched AbbVie’s pipeline with potential psychedelic-based therapies.


Atai Life Sciences (ATAI) is at the forefront of transforming mental health care, prioritizing the development of treatments for mental health disorders. Atai’s innovative strategy encompasses a wide array of compounds, including psychedelics. The company’s collaborative approach, partnering with leading firms to accelerate the development of groundbreaking therapies, exemplifies its commitment to pioneering advancements in mental health treatment.


Compass Pathways (CMPS) is pioneering the therapeutic use of psilocybin, focusing its research efforts on addressing treatment-resistant depression. The company’s clinical trials and research initiatives are part of a larger mission to establish psilocybin therapy as a validated treatment option, highlighting the potential of psychedelics to offer profound therapeutic benefits. Compass’s dedication to rigorous scientific inquiry and ethical research practices positions it as a leader in the psychedelic research community, contributing valuable insights that could reshape mental health care.


MindMed (MNMD) tands as an innovator in the neuro-pharmaceutical industry, delving into the therapeutic potential of psychedelics for treating a range of mental health conditions. MindMed’s exploratory work with substances such as LSD, MDMA, DMT, and psilocybin is driven by a vision to unlock new treatment pathways for conditions like anxiety, depression, and addiction. Recent advancements in MindMed’s research highlight the company’s role in pioneering the use of psychedelics as therapeutic agents, underscoring the potential of these substances to revolutionize mental health care.




PAID ADVERTISEMENT. This article is a paid advertisement. and its owners, managers, employees, and assigns (collectively “the Publisher”) is often paid by one or more of the profiled companies or a third party to disseminate these types of communications. In this case, the Publisher has been compensated by Cybin, Inc. (“Cybin” or “Company”) to conduct investor awareness advertising and marketing. Cybin paid the Publisher two hundred and fifty thousand US dollars to produce and disseminate one article profiling the Company over a period of one week. This compensation should be viewed as a major conflict with our ability to be unbiased.


Readers should beware that third parties, profiled companies, and/or their affiliates may liquidate shares of the profiled companies at any time, including at or near the time you receive this communication, which has the potential to hurt share prices. Frequently companies profiled in our articles experience a large increase in volume and share price during the course of investor awareness marketing, which often ends as soon as the investor awareness marketing ceases. The investor awareness marketing may be as brief as one day, after which a large decrease in volume and share price may likely occur.


This communication is not, and should not be construed to be, an offer to sell or a solicitation of an offer to buy any security. Neither this communication nor the Publisher purport to provide a complete analysis of any company or its financial position. The Publisher is not, and does not purport to be, a broker-dealer or registered investment adviser. This communication is not, and should not be construed to be, personalized investment advice directed to or appropriate for any particular investor. Any investment should be made only after consulting a professional investment advisor and only after reviewing the financial statements and other pertinent corporate information about the company. Further, readers are advised to read and carefully consider the Risk Factors identified and discussed in the advertised company’s SEC, SEDAR and/or other government filings. Investing in securities, particularly microcap securities, is speculative and carries a high degree of risk. Past performance does not guarantee future results. This communication is based on information generally available to the public and on interviews with company management, and does not (to the Publisher’s knowledge, as confirmed by Cybin) contain any material, non-public information. The information on which it is based is believed to be reliable. Nevertheless, the Publisher cannot guarantee the accuracy or completeness of the information.


SHARE OWNERSHIP. The Publisher owns shares and / or options of the featured company and therefore has an additional incentive to see the featured company’s stock perform well. The Publisher does not undertake any obligation to notify the market when it decides to buy or sell shares of the issuer in the market. The Publisher will be buying and selling shares of the featured company for its own profit. This is why we stress that you conduct extensive due diligence as well as seek the advice of your financial advisor or a registered broker-dealer before investing in any securities.


FORWARD LOOKING STATEMENTS. This publication contains forward-looking information which is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ from those projected in the forward-looking statements. Forward looking statements in this publication include, but are not limited to, the size and anticipated growth of the market for the companies’ products, the prospects for success of the Company’s drug pipeline, the reported scheduled release and commercialization of the Company’s drug pipeline, the ability to acquire customers and partners for the Company’s drug pipeline, and the projected growth and profit margins of the Company’s core product offerings.  Factors that could cause results to differ include, but are not limited to, the companies’ ability to fund its capital requirements in the near term and long term, the management team’s ability to effectively execute its strategy, the degree of success of the development and launch of the Company’s drug pipeline, competition, market saturation, market conditions, uncertain regulatory review, pricing pressures, etc. The forward-looking information contained herein is given as of the date hereof and we assume no responsibility to update or revise such information to reflect new events or circumstances, except as required by law.


INDEMNIFICATION/RELEASE OF LIABILITY. By reading this communication, you acknowledge that you have read and understand this disclaimer, and further that to the greatest extent permitted under law, you release the Publisher, its affiliates, assigns and successors from any and all liability, damages, and injury from this communication. You further warrant that you are solely responsible for any financial outcome that may come from your investment decisions.


TERMS OF USE. By reading this communication you agree that you have reviewed and fully agree to the Terms of Use found here If you do not agree to the Terms of Use, please contact to discontinue receiving future communications.


INTELLECTUAL PROPERTY. is the Publisher’s trademark. All other trademarks used in this communication are the property of their respective trademark holders.  The Publisher is not affiliated, connected, or associated with, and is not sponsored, approved, or originated by, the trademark holders unless otherwise stated. No claim is made by the Publisher to any rights in any third-party trademarks.


DISCLAIMER: is Source of all content listed above.  FN Media Group, LLC (FNM), is a third party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels. FNM is NOT affiliated in any manner with or any company mentioned herein.  The commentary, views and opinions expressed in this release by are solely those of and are not shared by and do not reflect in any manner the views or opinions of FNM.  FNM is not liable for any investment decisions by its readers or subscribers.  FNM and its affiliated companies are a news dissemination and financial marketing solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security.  FNM was not compensated by any public company mentioned herein to disseminate this press release.  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 FNM undertakes no obligation to update such statements.


Contact Information:

Media Contact e-mail:  U.S. Phone: +1(954)345-0611