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ATAI Life Sciences

ATAI Life Sciences NV is a clinical-stage biopharmaceutical company aiming to transform the treatment of mental health disorders. Its product candidates include COMP360/Psilocybin therapy, PCN-101/R-ketamine, RL-007/Compound, DMX-1002/Ibogaine, GRX-917/Deuterated etifoxine, VLS-01/DMT, EMP-01/MDMA derivative, RLS-01/Salvinorin A, KUR-101/Deuterated Mitragynine, and DMX-1001/Noribogaine. The business operates geographically in two regions being the United States and Germany.

ATAI Life Sciences NV

HC Wainwright &amp; Co. analyst Patrick Trucchio reiterates ATAI Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) with a Buy and maintains $10 price target.

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Price Target

Reiteration

Analyst Ratings

ATAI

HC Wainwright & Co. Reiterates Buy on ATAI Life Sciences, Maintains $10 Price Target

Co Reports: - A single dose of BPL-003, combined with relapse prevention therapy, produced meaningful and sustained reductions in alcohol use, with 50% of patients maintaining complete abstinence out to three months
- BPL-003 was well-tolerated with no serious or severe adverse events reported

Biotech

General

Atai Life Sciences Highlights Topline Results From Beckley Psytech's BPL-003 Phase 2a Open-Label Study For Alcohol Use Disorder

HC Wainwright &amp; Co. analyst Patrick Trucchio maintains ATAI Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) with a Buy and lowers the price target from $15 to $10.

HC Wainwright & Co. Maintains Buy on ATAI Life Sciences, Lowers Price Target to $10

Canaccord Genuity analyst Sumant Kulkarni maintains ATAI Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) with a Buy and maintains $11 price target.

Canaccord Genuity Maintains Buy on ATAI Life Sciences, Maintains $11 Price Target

Advanced <a href="https://www.benzinga.com/topic/ai">AI</a> has evolved over decades through research in computer science, neuroscience and machine learning. Early AI was rule-based, but breakthroughs in data processing, neural networks and deep learning have enhanced its ability to recognize patterns and learn from experience. With advances in algorithms, AI now handles complex tasks like healthcare diagnostics and personalized mental health treatments, paving the way for integration with <a href="https://www.benzinga.com/topic/psychedelic-assisted-therapies">psychedelic therapies</a>. 
According to a new <a href="https://nyaspubs.onlinelibrary.wiley.com/doi/full/10.1111/nyas.15229">white paper</a> from Psychae Therapeutics, a Melbourne-based pharmaceutical company, the application of AI for the <a href="https://www.benzinga.com/general/biotech/24/05/38768537/from-hype-to-reality-ai-reshapes-pharmaceutical-industry-across-drug-discovery-to-marketing-stock">discovery and development of new drugs</a> could reshape the future of mental health care. As Double Blind <a href="https://doubleblindmag.com/ai-is-changing-psychedelic-medicine/">reported</a>, the paper explores the potential of AI to revolutionize psychedelic medicine, highlighting the significant progress already underway.
<h3 class="wp-block-heading">Accelerating Drug Discovery With AI</h3>
AI is revolutionizing drug discovery by rapidly screening thousands of compounds to identify new psychedelic medicines. This speeds up the process of predicting a drug's effects, safety and efficacy, helping develop treatments that maintain therapeutic benefits while reducing side effects.
Pharmaceutical companies are already utilizing AI for drug discovery. For instance, researchers at the University of California-San Francisco recently <a href="https://www.benzinga.com/general/biotech/24/05/38711266/google-deepmind-develops-latest-ai-model-to-aid-scientists-in-fighting-disease">used AI program AlphaFold</a> to identify hundreds of thousands of potential new psychedelic compounds, which could be promising candidates for treating mental health disorders like depression.
<h3 class="wp-block-heading">Enhancing Clinical Trials Through AI</h3>
AI is making clinical trials for psychedelic therapies <a href="https://www.benzinga.com/markets/cannabis/23/06/32788090/ai-powered-psychedelic-treatments-special-status-and-next-gen-contests-winners">faster and more precise</a>. By analyzing patient data, AI can help determine the best dosing strategies and predict which patients are most likely to benefit from specific treatments. This tailored approach is a step beyond current practices like genetic screening, offering a more individualized treatment plan.
Moreover, AI can utilize wearable technology during clinical trials to monitor patients in real-time, providing immediate feedback on how the psychedelic treatments are affecting them. This data-driven approach can help fine-tune therapies and ensure more effective outcomes.
<h3 class="wp-block-heading">AI's Role In Shaping The Psychedelic Experience</h3>
Though the white paper does not specifically mention virtual reality (VR), <a href="https://www.benzinga.com/markets/cannabis/23/09/34097039/psychedelic-journeys-2-0-how-virtual-reality-is-revolutionizing-therapy">other recent developments </a>suggest that VR could enhance the psychedelic experience. AI could be used to <a href="https://www.benzinga.com/markets/cannabis/24/10/41215655/ketamine-clinics-los-angeles-partners-with-fireflyvr-for-virtual-reality-enhanced-patient-care">augment the therapeutic setting</a>, employing visual algorithms and personalized sensory inputs to create tailored environments that amplify the effects of the treatment. This could include immersive VR experiences designed to enhance the therapeutic impact of psychedelic sessions.
<h3 class="wp-block-heading">Supporting Post-Treatment Integration With AI</h3>
AI's influence extends beyond the treatment session itself. After therapy, AI-powered tools could offer personalized support to help patients integrate their psychedelic experiences into everyday life. By tracking patients' progress, these tools could provide ongoing strategies for maintaining mental health improvements, making post-treatment care more effective.
<h3 class="wp-block-heading">Addressing Ethical Concerns In Psychedelic Medicine</h3>
As AI becomes more deeply integrated into psychedelic medicine, ethical issues cannot be overlooked. While AI has shown promise in assisting with ethical decision-making, there are still significant concerns around data privacy and the protection of sensitive patient information. Ensuring that AI applications in this field adhere to strict ethical standards is critical, especially given the deeply personal nature of psychedelic therapies.
<h3 class="wp-block-heading">Innovative Companies Paving The Way</h3>
MindMed (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNMD#NASDAQ">MNMD</a>), Atai Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>), COMPASS Pathways (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMPS#NASDAQ">CMPS</a>) and Delic Holdings (OTCQB:<a class="ticker" href="https://www.benzinga.com/stock/DELCF#OTCQB">DELCF</a>) are leading the way in integrating AI with psychedelic medicine to advance mental health treatments. MindMed uses AI to identify psychedelic compounds and optimize treatments for anxiety, depression, and addiction. Atai Life Sciences partners with AI firms to improve clinical trials for treatment-resistant depression and anxiety. COMPASS Pathways applies AI to enhance data analysis and personalize depression treatments, while Delic Holdings integrates AI into its wellness services to create personalized plans. Together, these companies are transforming psychedelic medicine and mental health care with AI.
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Cannabis

Psychedelics

CMPS

DELCF

MNMD

AI And Psychedelics: A Marriage Made In Heaven For Mental Health Care?

Atai Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>), a clinical-stage biopharmaceutical company focused on mental health innovation, announced its third-quarter 2024 financial results Wednesday as well as updates on its clinical and corporate strategies. With notable advancements in its investigational programs, the company remains optimistic about its pipeline's potential to address <a href="https://www.benzinga.com/topic/psychedelic-assisted-therapies">treatment-resistant mental health conditions</a>.
<h3 class="wp-block-heading">Financial Overview: Strategic Investments And Cash Runway</h3>
Despite a challenging market environment, Atai's financial position remains strong, with sufficient resources to fund operations into 2026. The company reported cash, cash equivalents and short-term securities totaling $101 million as of September 30, 2024, compared to $154.2 million at the end of 2023. The decrease was primarily driven by operating expenses and strategic investments, including a $10 million commitment to <a href="https://www.benzinga.com/topic/beckley-psytech">Beckley Psytech</a>.
<ul>
<li>R&amp;D and G&amp;A Expenses: Research and development expenses for Q3 totaled $12.4 million, a slight decline from $13.3 million in Q3 2023. This reduction was attributed to lower personnel-related costs, partially offset by increased spending on advancing clinical trials. General and administrative expenses dropped to $10.3 million, down from $13.6 million in the prior year period, reflecting a $3.3 million reduction due to cost-saving measures.</li>
<li>Net Loss: Atai reported a net loss of $26.3 million for Q3 2024, compared to a net income of $44.2 million in the same period last year. The previous year's results were bolstered by a significant, non-cash gain from changes in the fair value of investments, an advantage not repeated this year.</li>
</ul>
<h3 class="wp-block-heading">Corporate Developments: Acquisition And Future Catalysts</h3>
In a strategic move to bolster its drug delivery capabilities, Atai completed the acquisition of IntelGenx Corp., a firm specializing in innovative oral thin film technologies. Notably, the transaction was structured without using Atai's cash or equity, underscoring the company's disciplined approach to capital management.
Looking ahead, Atai has set its sights on several key milestones:
<ul>
<li>Initiation of Phase 2 trials for VLS-01 and EMP-01 by year-end 2024.</li>
<li>Topline data from Beckley Psytech's BPL-003 Phase 2b trial for treatment-resistant depression, expected in Q2 2025.</li>
<li>Results from the ongoing Phase 2b study of RL-007, targeting cognitive impairment associated with schizophrenia, anticipated by mid-2025.</li>
</ul>
<h3 class="wp-block-heading">Key Pipeline Advancements</h3>
Atai&#8217;s pipeline gains momentum, with two major Phase 2 trials set to launch by year-end 2024:
VLS-01 for Treatment-Resistant Depression: Atai has received FDA approval for its IND application for VLS-01, a buccal film formulation of DMT for treatment-resistant depression. This novel delivery method, applied to the inside of the cheek, offers a streamlined two-hour in-clinic treatment. Atai plans to begin a Phase 2 study by the end of 2024 to evaluate VLS-01's safety, efficacy and durability in TRD patients.
EMP-01 for Social Anxiety Disorder: EMP-01 is an oral R-MDMA formulation with dose-dependent effects similar to classical psychedelics. Atai plans to begin a Phase 2 trial for social anxiety disorder (SAD) by the end of 2024. The trial will assess EMP-01's safety, tolerability and efficacy, addressing an unmet need as no new treatments for SAD have been approved in over 20 years.
IBX-210: IV Ibogaine for Opioid Use Disorder: Atai has completed a pre-IND meeting with the FDA for IBX-210, an intravenous ibogaine formulation for opioid use disorder. The company plans further non-clinical studies before launching a Phase 1b trial to explore its potential for substance use disorder, as part of Atai's broader research into addiction treatments.
<h3 class="wp-block-heading">Strategic Focus On Mental Health Innovation</h3>
"Atai is committed to transforming mental health treatment," emphasized Dr. Srinivas Rao, Co-CEO of Atai. "We believe that by advancing our diversified pipeline with scientific rigor, we are paving the way for novel, effective therapies for patients who have long been underserved by traditional treatments."
The company's emphasis on innovative delivery methods and AI-informed drug design highlights its strategic focus on developing <a href="https://www.benzinga.com/markets/cannabis/24/10/41191696/psychedelics-2-0-companies-explore-safer-more-targeted-therapies">next-generation therapies</a>. By targeting complex conditions such as treatment-resistant depression, social anxiety disorder and opioid use disorder, Atai aims to address significant gaps in the mental health treatment landscape.
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Earnings

Atai Q3 Report: Strong Cash Position, Clinical Pipeline Growth

ATAI Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) reported quarterly losses of $(0.16) per share which met the analyst consensus estimate. This is a 164 percent decrease over earnings of $0.25 per share from the same period last year. The company reported $40.00 thousand in sales this quarter. This is a 54.02 percent decrease over sales of $87.00 thousand the same period last year.

ATAI Life Sciences Q3 EPS $(0.16), Inline, Sales $40.00K Down From $87.00K YoY

Researchers from Emory University, the University of Wisconsin-Madison and UC-Berkeley have identified a significant opportunity for <a href="https://www.benzinga.com/topic/psilocybin-assisted-therapy">psilocybin-assisted therapy</a> in the U.S. mental healthcare landscape. As U.S. News <a href="https://www.usnews.com/news/health-news/articles/2024-09-13/over-5-million-americans-could-benefit-if-psilocybin-approved-for-depression-study">reported</a>, if approved by the <a href="https://www.benzinga.com/topic/food-and-drug-administration">FDA</a>, psilocybin could be used to treat depression, with an estimated 5.1 to 5.6 million Americans potentially benefiting from the therapy.
Examining a group of patients undergoing treatment for depression, researchers determined that psilocybin could be a game-changing solution, particularly for individuals suffering from major depressive disorder (MDD) or treatment-resistant depression (TRD). These conditions, which affect millions across the country, are typically unresponsive to standard treatments, underscoring the urgent need for new solutions.
<h3 class="wp-block-heading">A Breakthrough Approach To Treating Depression</h3>
The study, <a href="https://pp.genomicpress.com/wp-content/uploads/2024/09/PP0025-Rab-2024.pdf">published</a> in Psychedelics by Genomic Press, explored the FDA's consideration of psilocybin from <a href="https://www.benzinga.com/markets/cannabis/22/11/29549541/the-strongest-magic-mushroom-species">Psilocybe cubensis</a> mushrooms as a <a href="https://www.benzinga.com/general/biotech/24/03/37665900/fda-grants-cybin-breakthrough-therapy-status-for-major-depression-psilocybin-therapy-company-anno">breakthrough therapy,</a> which is a designation that allows drugs with the potential to address life-threatening conditions like severe depression, to be fast-tracked through the approval process. If green-lighted, psilocybin would likely be reserved for individuals with the most severe forms of depression or those who have not responded to traditional treatments.
The study found that some 1.7 million Americans with TRD could immediately benefit from psilocybin-assisted therapy. When including those with MDD, the number of potential beneficiaries rises to 5.6 million. Dr. Syed Fayzan Rab, an MD candidate at Emory University and the study's lead author, highlighted the importance of recognizing the scope of this opportunity. "This underscores the importance of understanding the practical realities of rolling out this novel treatment on a large scale."
<h3 class="wp-block-heading">A Market Ready To Take Off</h3>
Implications of this study go beyond healthcare. The psilocybin-assisted therapy market holds immense economic potential. A 2023 <a href="https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1293243/full">report</a> estimated that a single psilocybin-assisted therapy session could cost around $1,500 per patient. Considering the millions of individuals who may be eligible for treatment, this could translate into billions of dollars in revenue once psilocybin gains FDA approval.
Several companies are already preparing to capitalize on this potential market. Compass Pathways (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMPS#NASDAQ">CMPS</a>), Atai Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) and Mindset Pharma (OTC:<a class="ticker" href="https://www.benzinga.com/stock/MSSTF#OTC">MSSTF</a>) are among the pharmaceutical firms actively developing psilocybin-based treatments. 
<h3 class="wp-block-heading">Beyond Depression: Psilocybin's Expanding Horizon</h3>
While psilocybin's most immediate application lies in depression treatment, its therapeutic potential extends further. Ongoing studies are investigating psilocybin's efficacy in treating chronic pain and <a href="https://www.benzinga.com/topic/ptsd">post-traumatic stress disorder</a>. These developments signal that psilocybin could revolutionize not just mental healthcare but also the treatment of other chronic conditions.
However, psilocybin remains classified as a <a href="https://www.benzinga.com/topic/controlled-substances-act">Schedule I</a> drug at the federal level, meaning it is considered to have no accepted medical use and a high potential for abuse. This classification, shared with substances like marijuana, heroin and <a href="https://www.benzinga.com/topic/lsd">LSD</a>, complicates the path toward legalizing its medical use. 
Despite these federal restrictions, several U.S. states and local jurisdictions have <a href="https://www.benzinga.com/topic/psychedelics-decriminalization">decriminalized psilocybin</a> in recent years, signaling a growing push for policy reform at higher levels. 
"It's our hope that these findings spur productive discussions and proactive preparations to optimize the benefit to patients while minimizing unintended consequences," said Dr. Charles Raison, a professor of psychiatry at the University of Wisconsin and co-author of the study. 
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Regulations

Health Care

MSSTF

Could Psilocybin Be A Game-Changer For Millions Battling Depression? New Study Says Yes

Psychedelics have shown promise in treating various mental health issues, including <a href="https://www.benzinga.com/topic/ptsd">PTSD</a> and depression, but they&#8217;ve often faced notable challenges. Side effects like nausea, cardiovascular risks, and the potential for "bad trips" have raised concerns among both clinicians and patients. As Time <a href="https://time.com/7027173/new-psychedelic-drug-companies/">reported</a>, companies like Mindstate Design Labs and Atai Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) are developing new forms of psychedelics, sometimes called Psychedelics 2.0, designed to offer therapeutic benefits with fewer risks.
<h3 class="wp-block-heading">Challenges And Limitations Of Traditional Psychedelics</h3>
Traditional psychedelics like <a href="https://www.benzinga.com/topic/psilocybin">psilocybin</a>, <a href="https://www.benzinga.com/topic/mdma">MDMA</a> and <a href="https://www.benzinga.com/topic/lsd">LSD</a> work by <a href="https://www.benzinga.com/markets/cannabis/23/02/30965404/delix-elucidating-how-psychedelics-actually-induce-neuroplasticity-vs-ssris">promoting neuroplasticity</a>, which helps the brain form new connections and process trauma. However, these substances can be time-intensive, sometimes requiring patients to endure hours-long sessions under medical supervision. This protocol not only strains mental health resources but can also be daunting for patients.
Dillan DiNardo, CEO of <a href="https://www.benzinga.com/topic/mindstate-design-labs">Mindstate Design Labs</a>, describes classic psychedelics as "effective, but they're scary and unpredictable." His company aims to refine psychedelics to retain their mental health benefits while minimizing adverse effects. These novel drugs may also ease the burden on the mental health system, as the reduced risk could potentially allow for fewer monitoring requirements.
The FDA recently <a href="https://www.benzinga.com/markets/cannabis/24/08/40300943/fda-rejects-mdma-for-ptsd-treatment-calls-for-more-research-on-psychedelic-therapy">withheld approval of MDMA for PTSD treatment</a>, citing concerns over potential heart risks and the need for constant monitoring. Dr. Srinivas Rao, co-CEO of Atai Life Sciences, explains that these challenges have encouraged companies to find safer alternatives. One such development is <a href="https://www.benzinga.com/general/biotech/24/03/37973466/pharmalas-novel-mdma-mixture-awarded-us-patent-enabling-ip-protection-and-further-development">R-MDMA</a>, which offers a more introspective experience with fewer side effects.
<h3 class="wp-block-heading">Rethinking Psychedelic Therapy</h3>
Companies like Enveric Biosciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ENVB#NASDAQ">ENVB</a>) are taking a different approach by attempting to strip psychedelics of their hallucinogenic effects altogether. Enveric's CEO Joseph Tucker suggests that a <a href="https://www.benzinga.com/markets/cannabis/22/12/30007837/tripping-without-the-trip-non-hallucinogenic-psychedelics">non-hallucinogenic version of psychedelics</a>, if effective, could function much like an antidepressant, providing relief without the need for extensive in-clinic sessions.
This approach has its critics, however, with some researchers arguing that the psychedelic experience itself is essential to therapeutic progress. Studies suggest that feelings of connectedness, common in psychedelic experiences, are linked to improved mental health outcomes.
<h3 class="wp-block-heading">Selective Psychedelics: Targeted Effects For Improved Safety</h3>
Mindstate Design Labs is exploring ways to create psychedelics with more targeted effects on the brain. DiNardo likens psychedelics to "promiscuous molecules" that influence various neural pathways. By honing in on specific effects, Mindstate seeks to reduce the chaotic nature of traditional psychedelics and make the treatment experience more predictable.
<h3 class="wp-block-heading">The Future Of Psychedelic Therapy</h3>
While these developments offer promising solutions, the path to FDA approval and widespread acceptance remains complex. Whether future psychedelics can provide mental health benefits without the downsides of traditional compounds will depend on ongoing research and clinical trials. As DiNardo notes, "psychedelics do not work for everyone in a positive way." But with advances in Psychedelics 2.0, companies seem to be optimistic about creating more patient-friendly therapies for mental health challenges.
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ENVB

Psychedelics 2.0: Companies Explore Safer, More Targeted Therapies

The U.S. Food and Drug Administration (FDA) has issued a complete response letter for <a href="https://www.benzinga.com/topic/mdma-assisted-therapy">MDMA-assisted psychotherapy (MDMA-AT)</a> for treating post-traumatic stress disorder (PTSD) in which it calls for an additional phase 3 trial to further evaluate its safety and efficacy. As Psychiatric Times <a href="https://www.psychiatrictimes.com/view/with-mdma-on-hold-whats-next-for-psychedelics">reported</a>, this decision puts on hold what could have been a landmark approval for the treatment of PTSD with MDMA, also known as midomafetamine.
Despite the <a href="https://www.benzinga.com/markets/cannabis/24/08/40300943/fda-rejects-mdma-for-ptsd-treatment-calls-for-more-research-on-psychedelic-therapy">setback</a>, <a href="https://www.benzinga.com/topic/lykos-therapeutics">Lykos Therapeutics</a>, the company behind the MDMA-AT treatment, remains determined. Lykos has expressed confidence that the FDA's concerns could be addressed using "existing data, post-approval requirements or through reference to the scientific literature." Discussions between the company and the FDA are ongoing, as Lykos seeks a clear path forward.
<h3 class="wp-block-heading">Other Psychedelics In The Pipeline</h3>
While MDMA's future remains in question, several other psychedelic treatments continue to progress through clinical trials. Atai Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) recently announced promising results from a <a href="https://www.benzinga.com/markets/cannabis/24/08/40376236/atais-dmt-depression-drug-shows-promise-prepares-for-phase-ii-trial-and-future-collaboration-wit">phase 1b trial of VLS-01</a>, a buccal film formulation of N,N-dimethyltryptamine (DMT), for treatment-resistant depression (TRD). The next phase 2 study is expected to start by the end of 2024, focusing on safety, efficacy and durability of response.
Numinus Wellness (OTC:<a class="ticker" href="https://www.benzinga.com/stock/NUMIF#OTC">NUMIF</a>), another key player in the psychedelic space, is <a href="https://www.benzinga.com/markets/cannabis/23/11/35548014/single-dose-of-cybins-psilocybin-shows-compelling-patient-outcomes-phase-2-results-find">moving forward with studies</a> involving Cybin's CYB003, a deuterated psilocybin molecule designed for treating moderate to severe depressive disorders. Meanwhile, Compass Pathways (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMPS#NASDAQ">CMPS</a>) is testing COMP360, a synthetic form of psilocybin, which <a href="https://www.benzinga.com/markets/cannabis/23/09/34291309/compass-pathways-explores-ai-powered-predictive-model-on-psilocybin-therapy-for-depression">has shown promising early results</a> in treating PTSD. These developments highlight the continued push toward psychedelic-assisted therapies for a range of psychiatric conditions.
<h3 class="wp-block-heading">Progress With LSD And Ketamine</h3>
MindBio Therapeutics (NASDAQU:MBIO) has also made strides with MB22001, <a href="https://www.benzinga.com/markets/cannabis/24/04/38512570/lsd-microdosing-for-pms-after-confirming-antidepressant-effects-clinical-trials-will-assess-if-i">a titratable microdosing form of LSD</a>, showing promise in phase 2a trials for major depressive disorder (MDD). They are investigating LSD's potential for treating other conditions like premenstrual dysphoric disorder and depression associated with cancer. MindMed is <a href="https://www.benzinga.com/markets/cannabis/22/08/28637136/mindmed-keeps-hitting-the-news-now-dosing-on-their-clinical-trial-on-lsd-for-anxiety">progressing with its own LSD compound</a>, MM-120, which has shown potential for treating generalized anxiety disorder (GAD), with a phase 3 trial set to begin this year.
Ketamine-based therapies are advancing as well, with Awakn Life Sciences (OTC:<a class="ticker" href="https://www.benzinga.com/stock/AWAKNF#OTC">AWAKNF</a>) leading the charge in <a href="https://www.benzinga.com/markets/cannabis/23/06/32820420/awakn-to-focus-on-r-d-of-addiction-therapies-moves-away-from-ketamine-treatment-for-alcoholism">addressing alcohol use disorder</a>. Their MORE-KARE phase 3 trial is underway, testing the efficacy of ketamine infusions combined with psychosocial support.
<h3 class="wp-block-heading">Lykos And The Future Of MDMA</h3>
As the psychedelic field expands, all eyes are on Lykos Therapeutics as they navigate the FDA&#8217;s requirements for MDMA-assisted psychotherapy. The company has undergone a <a href="https://www.benzinga.com/markets/cannabis/24/08/40421048/lykos-therapeutics-strategic-reorganization-following-fdas-decision-rejecting-mdma-for-ptsd-trea">significant reorganization</a>, including a 75% reduction in workforce, and appointed Dr. David Hough as senior medical advisor to guide the next phase of clinical work. Hough has extensive experience in psychiatric drug development, having led successful projects such as Spravato.
Rick Doblin, PhD, founder of the Multidisciplinary Association for Psychedelic Studies (MAPS), has stepped down from Lykos to focus on public advocacy for global access to MDMA and other psychedelics. Doblin&#8217;s resignation from the Lykos Board comes as the company continues its dialogue with the FDA.
<h3 class="wp-block-heading">What's Next?</h3>
Despite the challenges facing <a href="https://www.benzinga.com/topic/mdma-assisted-therapy">MDMA-assisted psychotherapy</a>, the field of psychedelic research remains vibrant. With more than 185 clinical studies on psilocybin, 104 on MDMA and 58 on LSD ongoing according to clinicaltrials.gov, the future holds promise for these novel treatments. As companies continue their work, patients and researchers alike are hopeful that these therapies will become more widely available in the near future.
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AWAKNF

MBIO

NUMIF

MDMA Therapy For PTSD Faces FDA Delay: Are There Other Ways Forward?

The global <a href="https://www.benzinga.com/markets/psychedelics">psychedelic drugs</a> market is poised for significant growth over the next five years, with an estimated increase of USD 1.37 billion from 2024 to 2028, according to a <a href="https://www.prnewswire.com/news-releases/psychedelic-drugs-market-to-grow-by-usd-1-37-billion-from-2024-2028--driven-by-increasing-mental-health-disorders-report-highlights-ais-impact-on-the-market-landscape---technavio-302236016.html">report</a> by Technavio. The market is projected to grow at a compound annual growth rate (CAGR) of 11.82%, fueled by the rising prevalence of mental health disorders and the development of next-generation therapies for psychiatric conditions.
<h3 class="wp-block-heading">Expanding Market For Psychedelics In Mental Health</h3>
Increasing awareness of the <a href="https://www.benzinga.com/topic/psychedelic-assisted-therapies">therapeutic potential</a> of psychedelic substances, such as <a href="https://www.benzinga.com/topic/ketamine">ketamine</a>, <a href="https://www.benzinga.com/topic/psilocybin">psilocybin</a>, and <a href="https://www.benzinga.com/topic/mdma">MDMA</a>, has spurred investment in research and development. These substances have shown promise in treating disorders like treatment-resistant depression, PTSD, narcolepsy and addiction. The market is also witnessing a trend towards AI-driven advancements in the understanding and development of psychedelic therapies.
However, regulatory challenges and potential side effects associated with psychedelic drugs present obstacles to market growth. Many substances remain classified as <a href="https://www.benzinga.com/topic/federal-schedule-i">Schedule I</a> drugs, creating barriers to widespread availability, especially in hospital and retail pharmacies.
<h3 class="wp-block-heading">Major Players And Market Segments</h3>
Key players in the psychedelic drugs market include AbbVie Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>), ATAI Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>), COMPASS Pathways (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/COMP#NYSE">COMP</a>), Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and Mind Medicine Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNMD#NASDAQ">MNMD</a>). These companies are at the forefront of developing safe and effective psychedelic therapies for mental health conditions.
The market is segmented by type, including ketamine, GHB, MDMA and psilocybin. Distribution channels such as hospital pharmacies, retail pharmacies and others play a critical role in the accessibility of these therapies. Geographically, North America, Europe, Asia and the rest of the world (ROW) are identified as major regions driving growth.
<h3 class="wp-block-heading">AI's Role In Shaping The Psychedelic Drugs Market</h3>
<a href="https://www.benzinga.com/topic/artificial-intelligence">Artificial intelligence</a> is becoming an essential tool in drug development and market evolution, helping companies streamline research, clinical trials, and product development. By integrating AI, firms can accelerate the creation of targeted therapies and better understand the complex interactions between psychedelic drugs and mental health conditions.
<h3 class="wp-block-heading">Market Challenges And Ethical Concerns</h3>
Despite its growth potential, the psychedelic drugs market faces significant challenges, including regulatory scrutiny and ethical concerns. The potential for misuse and psychological distress associated with psychedelic substances, especially in forms like injectable or intranasal psilocybin, remains a concern. Cultural norms, conservative values, and religious beliefs also influence the pace of adoption in various regions.
<h3 class="wp-block-heading">Future Outlook</h3>
As companies continue to push forward with clinical trials and product development, the market for psychedelic drugs is expected to expand significantly. The anticipated approval of new psychedelic-based therapies, coupled with AI-driven innovations, holds promise for addressing the global mental health crisis. However, overcoming regulatory and cultural barriers will be critical to unlocking the full potential of this emerging field.

Press Releases

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Psychedelic Drugs Market Set To Grow By $1.37B By 2028, Driven By Mental Health Disorders And AI Integration

HC Wainwright &amp; Co. analyst Patrick Trucchio reiterates ATAI Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) with a Buy and maintains $15 price target.

HC Wainwright & Co. Reiterates Buy on ATAI Life Sciences, Maintains $15 Price Target

Atai Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) announced promising preliminary results on Tuesday for its DMT-based depression therapy, <a href="https://www.benzinga.com/markets/cannabis/23/10/35070268/atai-life-sciences-completes-phase-1-clinical-study-of-oral-film-dmt-formulation">VLS-01</a>. As BioSpace <a href="https://www.biospace.com/drug-development/atai-touts-early-data-on-psychedelic-depression-drug-plans-phase-ii-trial">reported</a>, these findings from a Phase Ib study position Atai to move forward with a Phase II trial later this year, targeting patients with <a href="https://www.benzinga.com/topic/treatment-resistant-depression">treatment-resistant depression</a>.
<h3 class="wp-block-heading">Promising Phase Ib Results For DMT-Based Depression Therapy</h3>
VLS-01, an oral formulation of <a href="https://www.benzinga.com/topic/dmt">N,N-dimethyltryptamine (DMT)</a>, is designed to be administered via a buccal film applied to the lining of the cheek. This delivery method aims to induce a short, controlled psychedelic experience, potentially offering relief to those suffering from treatment-resistant depression. The active ingredient is different from other psychedelic therapies, such as <a href="https://www.benzinga.com/topic/lykos-therapeutics">Lykos Therapeutics'</a> MDMA, which was <a href="https://www.benzinga.com/markets/cannabis/24/08/40300943/fda-rejects-mdma-for-ptsd-treatment-calls-for-more-research-on-psychedelic-therapy">recently rejected by the FDA</a>, or <a href="https://www.benzinga.com/topic/compass-pathways">Compass Pathways'</a> psilocybin treatments, VLS-01 provides a unique approach to addressing mental health challenges, say company officials.
<h3 class="wp-block-heading">The Phase Ib Study</h3>
The research involved 17 healthy volunteers, who received a single intravenous dose of DMT followed by three different doses of the buccal formulation, administered 28 days apart. The study aimed to compare the safety, tolerability, pharmacokinetics and pharmacodynamics of the buccal film to the intravenous form. The results were encouraging, with the two higher doses (120mg and 160mg) achieving peak plasma concentrations comparable to the intravenous dose.
Atai <a href="https://www.globenewswire.com/news-release/2024/08/13/2929035/0/en/atai-Life-Sciences-Announces-Positive-Preliminary-Results-from-Phase-1b-Trial-of-VLS-01-Buccal-Film-DMT.html">reported</a> &#8220;dose-dependent and robust subjective effects&#8221; at these higher doses, with 13 out of 14 participants scoring greater than 7 out of 10 on the Subjective Intensity Rating Scale at the 120mg dose. The effects were noted to resolve completely after two hours, with participants describing the experience as &#8220;psychologically meaningful&#8221; and highlighting an increase in &#8220;levels of self-reflection.&#8221;
<h3 class="wp-block-heading">Safety Profile And Next Steps</h3>
The safety profile of VLS-01 was another positive outcome of the study. The most common treatment-emergent adverse events (TEAEs) reported were headache, dissociation, euphoric mood, and nausea. All adverse events were mild or moderate and resolved on the day of dosing, with no reports of vomiting or local irritation at doses of 120mg or less. Only one participant reported nausea at the 120mg dose, and there were no incidents of suicidality.
Building on these results, Atai has <a href="https://clinicaltrials.gov/study/NCT06524830">filed to conduct a Phase II</a> trial by the end of 2024, which will compare VLS-01 to a placebo in 142 patients with treatment-resistant depression. This study will evaluate the efficacy, safety, and durability of repeated doses of VLS-01 in patients with TRD, and is expected to provide topline data by the end of 2025.
<h3 class="wp-block-heading">Strategic Positioning And Future Outlook</h3>
"We're delighted with the positive results from the VLS-01 Phase 1b study, which further support its potential as a promising therapeutic option for the 100 million people worldwide suffering from treatment-resistant depression," said Dr. Srinivas Rao, co-CEO and co-founder of Atai.
Atai's strategic approach to developing a psychedelic that can be administered within a two-hour clinic visit could align it with existing infrastructure used for administering <a href="https://www.benzinga.com/topic/johnson-johnson">Johnson &amp; Johnson's</a> ketamine-based depression drug, <a href="https://www.benzinga.com/markets/cannabis/24/07/39913847/pharma-giant-johnson-johnson-asks-fda-to-approve-esketamine-nasal-spray-for-treatment-resistant-">Spravato</a>. 
Atai co-CEO Florian Brand, speaking at H.C. Wainwright's Neuro Perspectives Conference in June 2024, highlighted the potential to leverage the &#8220;very compelling infrastructure&#8221; established by Spravato&#8217;s more than 4,000 certified clinics. &#8220;With [J&amp;J] now guiding to achieve beyond a billion of sales this year, we believe we have a very compelling infrastructure that we can leverage with this compound,&#8221; Brand said.
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Atai's DMT Depression Drug Shows Promise, Prepares For Phase II Trial And Future Collaboration With Pharma Giant

Guidance

atai Life Sciences Expects Cash, Marketable Securities, And Committed Term Loan Funding To Fund Operations Into 2026

atai Life Sciences Q2 EPS $(0.36), Down From $(0.21) Last Year; License Revenue $273K, Up From $172K Prior Year

In a historic move for the psychedelics industry, PATOO, a Jamaica-based psychedelic consumer packaged goods (CPG) brand, has announced a partnership with Fontana Pharmacy, the island's leading pharmacy chain with more than 500 employees across 7 locations, <a href="https://www.benzinga.com/cannabis">Benzinga</a> has learned exclusively. This landmark collaboration introduces the first legal psilocybin-infused products to Jamaican pharmacy shelves, marking a significant step toward broader acceptance and accessibility of psychedelic wellness products.
<h2 class="wp-block-heading">Psychedelics At The Pharmacy? A Reality In Jamaica</h2>
&#8220;Jamaica has evolved into a sanctuary for those pursuing inner healing, and we are honored to offer our meticulously crafted products as alternative plant-based remedies to consumers. We prioritize safety and quality, rigorously testing each batch to ensure the utmost standards,&#8221; said Kevin Bourke, co-founder of PATOO.
Products include microdose capsules, handcrafted microdose honey, premium chocolate bars and vegan psilocybin gummies, all presented in childproof packaging to prevent underage consumption and ensure responsible use. 
Each batch of psilocybin products is rigorously tested to ensure the highest quality and safety standards, as emphasized by the commitment of PATOO and their partnership with Fontana Pharmacy. This includes adhering to local regulatory guidelines and ensuring product safety for consumers.
<h2 class="wp-block-heading">Psilocybin&#8217;s Global Presence: Legal Status And Access</h2>
Netherlands: In the Netherlands, psilocybin truffles have found a legal niche, despite psilocybin mushrooms being illegal. This loophole allows psilocybin truffles to be sold legally in &#8220;Smart Shops&#8221; across the country, providing a model for how psychedelics can be integrated into a retail environment under specific regulatory frameworks​.
Australia: Australia recently made headlines by allowing the prescription of psilocybin for certain psychiatric conditions such as PTSD and treatment-resistant depression. This regulatory change followed extensive clinical trials and approval from the Therapeutic Goods Administration (TGA). These prescriptions are tightly controlled and monitored, ensuring safe and effective use for medical purposes​.
Canada: In Canada, psilocybin can be accessed through the Special Access Program (SAP) for medical purposes, particularly for end-of-life distress, PTSD and depression. The approval process involves stringent applications and oversight by Health Canada, reflecting the country's cautious yet progressive stance on psychedelic therapy​.
<h2 class="wp-block-heading">The Jamaican Framework: A Model Of Controlled Access</h2>
Jamaica's approach to psilocybin is unique, given its historical tolerance and evolving regulatory landscape. Unlike the prescription-only models seen in Australia and Canada, Jamaica allows broader retail distribution of psilocybin products under controlled conditions. The Jamaican government actively promotes the country as a destination for psychedelic research and development, with interim protocols ensuring the safety and quality of psilocybin products​.
Products are stored securely behind the counter, and all retail displays and educational materials are labeled with age restrictions and safe use instructions. Staff at Fontana locations have undergone thorough training on dosage, benefits and safety measures, ensuring informed and responsible use by consumers, a PATOO spokesperson told Benzinga.
<h2 class="wp-block-heading">Broader Implications And Future Prospects</h2>
The introduction of psilocybin products into Jamaican pharmacies is more than a commercial achievement, it is a testament to the growing acceptance and integration of psychedelics into mainstream wellness practices. Jamaica, along with the Netherlands, Australia and Canada, is at the forefront of this movement, setting a precedent for other nations considering similar regulatory changes.
&#8220;We believe that PATOO's meticulously crafted products provide safe and effective plant-based alternatives for wellness, and we are excited to make these groundbreaking solutions accessible across Jamaica,&#8221; said Bourke. 
As the landscape of psychedelic wellness continues to evolve, the successful integration of psilocybin products into pharmacies in Jamaica and other forward-thinking nations offers a promising blueprint for the future. 
<h2 class="wp-block-heading">Key Publicly Traded Companies In The Psychedelics Industry</h2>
Several publicly traded companies are at the forefront of developing and commercializing psychedelic therapies, contributing to the growing legitimacy and acceptance of psychedelic treatments. Here are some notable companies:
<ul>
<li>Compass Pathways (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMPS#NASDAQ">CMPS</a>): Specializes in psilocybin-based therapies for treatment-resistant depression.</li>
<li>Atai Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>): Focuses on a portfolio of psychedelic substances, including psilocybin, through various partnerships and collaborations​.</li>
<li>Cybin Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CYBN#NYSE">CYBN</a>): Developing multiple psilocybin therapies for conditions like major depressive disorder and alcohol use disorder​​.</li>
<li>Mind Medicine (MindMed) Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MNMD#NASDAQ">MNMD</a>): Engages in psychedelic and plant-based therapies for mental health conditions such as anxiety and substance abuse​.</li>
<li>Mydecine Innovations Group Inc. (OTC:<a class="ticker" href="https://www.benzinga.com/stock/MYCOF#OTC">MYCOF</a>): A life sciences company focused on developing psychedelic medicine and natural health products, with several clinical trials underway.</li>
<li>Seelos Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SEEL#NASDAQ">SEEL</a>): Working on treatments for CNS disorders using ketamine and psilocybin​.</li>
<li>Revive Therapeutics Ltd. (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RVVTF#OTC">RVVTF</a>): Researching psilocybin-based therapeutics for various mental health conditions​.</li>
<li>Havn Life Sciences (CSE:<a class="ticker" href="https://www.benzinga.com/stock/HAVN#CSE">HAVN</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/HAVLF#OTC">HAVLF</a>): Engages in the research and development of natural health products and psychedelic compounds.</li>
<li>Red Light Holland (CSE:<a class="ticker" href="https://www.benzinga.com/stock/TRIP#CSE">TRIP</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/TRUFF#OTC">TRUFF</a>): Distributes legal recreational psilocybin truffles in the Netherlands​.</li>
</ul>
These companies are leading the charge in the development of psilocybin therapies, contributing to a broader acceptance of psychedelics in medical and wellness contexts.
Stay tuned to <a href="https://www.benzinga.com/cannabis">Benzinga</a> for more developments in the psychedelics industry.

Exclusives

CSE:HAVN

CSE:TRIP

CYBN

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MYDECINE INNOV GRP by MYDECINE INNOVATIONS GROUP INC.

MYCOF

RVVTF

SEEL

TRIP

RED LIGHT HOLLAND CORP by Red Light Holland Corp.

TRUFF

EXCLUSIVE: Legal Magic Mushroom Products Will Be Sold In Jamaica As Psilocybin Products Hit Pharmacy Shelves

Cantor Fitzgerald analyst Charles Duncan reiterates ATAI Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ATAI#NASDAQ">ATAI</a>) with a Overweight.

Cantor Fitzgerald Reiterates Overweight on ATAI Life Sciences

<ul>
<li>ELE-101 is a patent-protected, synthetic formulation of psilocin, designed to offer the therapeutic benefits of psilocybin in a more consistent, controllable, and shorter treatment paradigm of approximately two hours.</li>
<li>The Phase 2a part of the study will evaluate the safety, tolerability, subjective effects, and efficacy of a single intravenous (IV) dose of ELE-101 in 6-12 participants with Major Depressive Disorder (MDD). Results are expected in H2 2024.</li>
<li>The dose for Phase 2a was selected using preliminary pharmacokinetic (PK) and pharmacodynamic (PD) data from the Phase 1 randomized, double-blind, placebo-controlled, single ascending dose part of the study of ELE-101 in healthy participants, which showed that it was well-tolerated with no serious adverse events. ELE-101 showed a dose-proportional PK profile and a reliable induction of short-duration psychedelic experiences.</li>
</ul>

Atai Life Sciences Announced An Update On Beckley Psytech's Phase 1/2A Trial Of ELE-101 For Major Depressive Disorder, With Initial Results From Phase 1 And The Dosing Of The First Patients In The Phase 2A Part Of The Study

Psychedelic drug developer Lykos could get lifeline from former Tesla board member

In this edition of "Rising High," The Fly conducted an exclusive interview with Erez Aminov, Chairman & Chief Executive Officer of MIRA Pharmaceuti...

Rising High: Exclusive talk with pharmaceutical development company MIRA

In this edition of "Rising High," The Fly conducted an exclusive interview with Gibran Washington, Chief Executive Officer of ETHOS Cannabis, a mul...

Rising High: Exclusive talk with MSO ETHOS Cannabis

ATAI Life Sciences ( ($ATAI) ) has issued an announcement. On January 19, 2025, Michael Auerbach resigned from ATAI Life Sciences N.V.'s supervisor...

ATAI Life Sciences Board Member Resignation and Changes

atai Life Sciences (ATAI) announced topline results from Beckley Psytech's Phase 2a open-label study of BPL-003 in 12 patients with moderate to sev...

Atai Life Sciences announces results from BPL-003 Phase 2a open-label study

Patrick Trucchio, an analyst from H.C. Wainwright, reiterated the Buy rating on ATAI Life Sciences (ATAI – Research Report). The associated price t...

ATAI Life Sciences Rated Buy by Patrick Trucchio: Promising Phase 2a Trial Results and Favorable Valuation Analysis

Atai reports positive data for psychedelic drug BPL-003

Atai Life Sciences: Positive BPL-003 Data In AUD Leads To Another Catalyst

HHS Secretary nominee RFK Jr. faces contentious Senate hearing

In this week's "Psychedelic," The Fly's recurring series focused on psychedelic stock news, The Fly looks back on study results, an analyst initiat...

Psychedelic: atai Life Sciences reports BPL-003 study results

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Revolutionizing Mental Healthcare With The Rise Of Ketamine And Psychedelic Therapies

atai Life Sciences to Participate in the H.C. Wainwright 5th Annual Neuro Perspectives Conference

atai Life Sciences to Participate in the Canaccord Genuity 44th Annual Growth Conference

atai Life Sciences Announces Positive Preliminary Results from Phase 1b Trial of VLS-01 (Buccal Film DMT)

atai Life Sciences Reports Second Quarter 2024 Financial Results and Provides Corporate Updates

atai Life Sciences to Participate in the H.C. Wainwright 26th Annual Global Investment Conference

atai Life Sciences to Participate in the 2024 Maxim Healthcare Virtual Summit

Management

Altimmune Appoints Life Sciences Industry Veteran Greg Weaver as Chief Financial Officer

atai Life Sciences Reports Third Quarter 2024 Financial Results and Provides Corporate Updates

atai Life Sciences Announces Key Leadership Appointments as it Advances its Pipeline of Novel Psychedelic Therapeutics for Mental Health

atai Life Sciences Announces Positive Topline Results from Beckley Psytech's BPL-003 (intranasal 5-MeO-DMT benzoate) Phase 2a Open-Label Study for Alcohol Use Disorder

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