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LONDON, March 19, 2024 /PRNewswire/ — 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

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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.

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“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.

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