Psychedelics

LOS ANGELES- Colorado lawmakers have introduced House Bill 25-1063, a bipartisan proposal that would permit the prescription of crystalline polymorph psilocybin—a synthetic form of the psychedelic compound—contingent upon approval by the U.S. Food and Drug Administration (FDA). The bill, sponsored by Representatives Anthony Hartsook (R) and Kyle Brown (D), aims to provide healthcare providers with an additional treatment option for patients experiencing conditions such as post-traumatic stress disorder (PTSD) and treatment-resistant depression. Representative Hartsook, a combat veteran, emphasized the potential benefits for veterans, stating, "This bill is about a prescription-level medication that's a derivative... designed to treat veterans or anybody that has PTSD, a traumatic brain injury, depression that hasn't ...

LOS ANGELES- Recent studies indicate that psilocybin-assisted psychotherapy may alleviate depression among healthcare professionals affected by the COVID-19 pandemic. A randomized clinical trial conducted by the University of Washington involved 30 frontline clinicians experiencing moderate to severe depression. Participants received either a 25 mg dose of psilocybin or a placebo, alongside psychotherapy sessions. The psilocybin group exhibited a significant reduction in depression symptoms compared to the placebo group, with improvements sustained over six months. This research suggests that psilocybin, combined with psychotherapy, could be a viable treatment for depression in healthcare workers resulting from pandemic-related stress. However, experts emphasize the necessity for larger-scale studies to confirm these findings and to assess ...

LOS ANGELES- Compass Pathways, a biotechnology company specializing in mental health innovations, has commenced the UK segment of its global Phase 3 clinical trial evaluating COMP360 psilocybin therapy for treatment-resistant depression (TRD). This initiative follows approval from the UK's Medicines and Healthcare products Regulatory Agency. The Phase 3 program comprises two pivotal trials: COMP 005 and COMP 006. The COMP 006 trial, now active in the UK, will assess three dosage levels of COMP360 (25mg, 10mg, and 1mg) across multiple research sites, including the newly established Centre for Mental Health Research and Innovation in London. The Centre for Mental Health Research and Innovation, officially opened on November 15, 2023, is ...

LOS ANGELES- In Ottawa, several storefronts openly selling psilocybin, the psychoactive compound in magic mushrooms, continue to operate with minimal interference from local law enforcement. This contrasts with actions in other Canadian municipalities, where authorities have conducted raids and shut down similar establishments. The Golden Teacher, located at the corner of Rideau and Dalhousie streets, has been in operation since December 2021, offering products such as dried mushrooms, gummies, chocolates, and microdose capsules containing psilocybin. Another retailer, Shroomyz, situated on Preston Street, commenced operations in May 2022. Despite the illegality of psilocybin sales under the Controlled Drugs and Substances Act, these businesses have remained largely unimpeded. In August 2023, Ottawa ...

LOS ANGELES- Kaya Holdings, Inc. a in wellness and mental health solutions, has announced an inaugural open house event for its psilocybin treatment center, The Sacred Mushroom™. The event will take place on Friday, December 27, 2024, from 5:00 PM to 8:00 PM, at its facility in Portland, Oregon. The open house offers attendees an exclusive opportunity to explore the center's private treatment rooms, indoor garden, and therapeutic activities, which include artistic expression, music, movement, and mindfulness practices. Guests will also receive detailed information on the center's services and the upcoming series of psilocybin microdosing sessions. The Sacred Mushroom™ is launching a new initiative, “Community, Culture, and a Touch of ...

LOS ANGELES- The U.S. Food and Drug Administration (FDA) has issued a warning regarding the use of Amanita muscaria (fly agaric) mushrooms and their psychoactive compounds—muscimol, ibotenic acid, and muscarine—in food products. The FDA has determined that these substances are not approved for use in conventional foods and may pose health risks to consumers. This action follows reports of adverse health events, including illnesses and fatalities, linked to the consumption of edibles containing these compounds. Notably, products marketed as "psychedelic edibles" or "legal psychedelics," which often resemble conventional snacks, have been associated with serious health issues such as seizures, confusion, and abnormal heart rates. The FDA's assessment concluded that Amanita ...

LOS ANGELES- Recent studies indicate that psychedelics, particularly psilocybin, may help reduce depression, anxiety, and existential distress in patients with terminal illnesses. A systematic review published in Psychopharmacology analyzed data from various studies and found that psychedelic-assisted therapy led to significant reductions in these symptoms among patients facing life-threatening conditions. Another review in Current Oncology Reports highlighted psilocybin's potential benefits in palliative care, noting its favorable safety profile and sustained anxiolytic and antidepressant effects. However, the review also emphasized the need for more extensive research to address limitations such as selection bias and short follow-up periods. Despite these promising findings, challenges remain in integrating psychedelic therapies into standard end-of-life care. ...

The global psychedelic drugs market is projected to expand from $0.7 billion in 2022 to $2.6 billion by 2032, reflecting a compound annual growth rate (CAGR) of 13.4%.According to Allied Market Research This growth is driven by increasing acceptance of alternative mental health treatments and substantial investments in psychedelic research and development. Market Drivers Rising Prevalence of Mental Health Disorders: The increasing incidence of conditions such as depression, anxiety, and post-traumatic stress disorder (PTSD) has led to a demand for innovative therapeutic options, including psychedelic-assisted therapies. Advancements in Clinical Research: Ongoing studies are exploring the efficacy of substances like psilocybin and ketamine in treating various mental health conditions, contributing to ...

LOS ANGELES- HYTN Innovations Inc., a pharmaceutical company specializing in psychoactive and psychotropic compounds, including cannabis and psilocybin, has received initial orders and import permits from the United Kingdom's 4C Labs. This development enables HYTN to commence exporting cannabis-based pharmaceuticals to the UK under recently established agreements. The first shipment, produced in compliance with Good Manufacturing Practices (GMP) standards, signifies HYTN's commitment to delivering high-quality cannabis products to international markets. CEO Elliot McKerr remarked, "This milestone underscores the strength of our collaboration and signals the shift from a domestic to international cannabis company." To facilitate this export, HYTN completed registration with the UK's National Drugs Control System (NDS), authorizing transactions ...

LOS ANGELES- Cybin Inc., has announced promising results from its Phase 2 study of CYB003, a proprietary deuterated psilocybin analog developed for the treatment of major depressive disorder (MDD). The study demonstrated that 79% of patients achieved remission from depression symptoms six weeks after receiving two 12mg doses of CYB003. The trial also reported rapid and significant improvements in depression symptoms following a single dose of CYB003. Patients experienced an average reduction of 13.75 points on the Montgomery–Åsberg Depression Rating Scale (MADRS) at the three-week mark, a statistically significant difference from the placebo group. The administration of a second dose at six weeks resulted in an additional 5.8-point improvement on ...

LOS ANGELES- A new study published in Molecular Psychiatry has identified psilocybin, a psychedelic compound, as a promising candidate for the treatment of obsessive-compulsive disorder (OCD) and Tourette's syndrome. Conducted by researchers at the Hadassah-Hebrew University Medical Center, the study highlights the long-lasting therapeutic effects of psilocybin in preclinical trials using animal models. Led by Professor Bernard Lerer, the research focused on genetically modified mice that exhibit behaviors akin to OCD-like symptoms—such as excessive grooming—and tics, which are characteristic of Tourette's syndrome. The study evaluated the impact of a single dose of psilocybin, a psychedelic mushroom extract, or a placebo, with researchers observing the results over a three-week period. The ...

LOS ANGELES- Massachusetts voters have rejected a proposed measure to legalize the medical use of certain psychedelics, with 57% voting against and 43% in favor. The initiative sought to permit the use of psilocybin, psilocin, dimethyltryptamine (DMT), ibogaine, and mescaline for therapeutic treatment in patients aged 21 and older. It would have allowed patients to grow these substances at home and undergo treatment at licensed centers under the guidance of certified facilitators. The measure's supporters argued that psychedelic therapies could significantly benefit patients struggling with mental health issues such as depression, PTSD, and cancer-related anxiety. They also suggested the initiative could create a pathway to tax revenue from a regulated ...

LOS ANGELES- Cybin Inc., a neuropsychiatric biopharmaceutical company, announced that it has secured a U.S. patent (No. 12,122,741) covering the composition of matter for key molecules in its CYB005 program. This patent represents a strategic step for Cybin in developing non-hallucinogenic treatment options targeting central nervous system (CNS) disorders. The company’s CYB005 compounds, derived from the phenethylamine class, are being investigated for their ability to address mental health conditions by engaging serotonin 5-HT1A and 5-HT2C receptors—well-known targets in CNS therapeutic research. In recent years, interest in non-psychedelic treatments within the psychedelics field has risen, as companies seek compounds that can yield therapeutic benefits without hallucinogenic effects. Doug Drysdale, Cybin’s CEO, ...

LOS ANGELES- Psyence Biomed, a biopharmaceutical company focused on psychedelic therapeutics, has provided an update on its development of high-purity psilocybin in collaboration with PsyLabs. The company is working towards producing Active Pharmaceutical Ingredients (APIs) certified under the European Union’s Good Manufacturing Practices (GMP). This certification is critical for advancing psilocybin as a treatment for Alcohol Use Disorder (AUD). The progress update highlights PsyLabs' commitment to supplying high-purity, pharmaceutical-grade psilocybin for future clinical trials. Psyence Biomed’s partnership with PsyLabs also includes a pending acquisition of an equity stake, which will further integrate the two companies. This collaboration is expected to streamline the production and distribution of nature-derived psilocybin, facilitating its ...

LOS ANGELES- The psychedelics market in the U.S. is witnessing rapid expansion, driven by both regulatory advancements and increasing investor interest. The sector, valued at approximately $603.1 million in 2024, is projected to grow at a compound annual growth rate (CAGR) of 7%, with expectations of reaching $1.18 billion by 2034. This growth stems largely from the rising interest in psychedelics as treatments for mental health conditions such as post-traumatic stress disorder (PTSD), treatment-resistant depression, and addiction. Key regulatory developments have bolstered the industry. In 2024, the U.S. Food and Drug Administration (FDA) granted breakthrough therapy designations for psilocybin and MDMA, signaling accelerated development and testing of these drugs for ...

LOS ANGELES- Massachusetts voters are set to decide on Question 4 in the upcoming November 5 ballot, which proposes the legalization and regulation of certain psychedelic substances for therapeutic and personal use. If approved, Massachusetts would join Oregon and Colorado as states that have enacted similar measures. Recent polling indicates a closely contested issue: 42% of voters support the initiative, while 44% oppose it. The proposed law would permit adults aged 21 and over to possess, cultivate, and use specific natural psychedelics, including psilocybin, psilocyn, mescaline, DMT, and ibogaine, under regulated conditions. Advocates highlight potential mental health benefits, citing research that suggests these substances can aid in treating conditions like ...

LOS ANGELES- The New Jersey Senate Budget and Appropriations Committee has approved Senate Bill 2283, advancing legislation to legalize the therapeutic use of psilocybin for medical purposes. The bill, sponsored by Senate President Nick Scutari (D), comes after months of deliberation and amendments that shifted the focus from adult recreational use to strictly medical applications. The bill, if enacted, would allow individuals with qualifying medical conditions, as determined by a licensed health care professional, to use psilocybin under a regulated system. The New Jersey Department of Health would oversee the production and distribution process, granting licenses for five specific sectors: testing laboratories, manufacturers, facilitators, service centers, and psilocybin workers. The ...

LOS ANGELES- Psyence Biomedical Ltd. a life science biotechnology company focused on natural psychedelics for mental health, has issued updates on its progress in clinical research and corporate development. The company is leading efforts to develop natural psilocybin products for palliative care, with a focus on addressing psychological trauma and mental health challenges. Psyence is currently conducting a double-blind, placebo-controlled Phase IIb clinical trial in Australia, testing nature-derived psilocybin in three doses (25mg, 10mg, and 1mg) combined with psychotherapy. The trial aims to improve the quality of life for patients suffering from Adjustment Disorder, particularly those with life-limiting illnesses. The study’s primary endpoint is the change in the Hamilton Anxiety ...

LOS ANGELES- Silo Pharma, Inc. a developmental stage biopharmaceutical company, has submitted a proposal for FDA approval of its PTSD treatment, SPC-15, through the 505(b)(2) regulatory pathway. This pathway is designed to shorten clinical timelines and reduce development costs. The company recently completed a pre-Investigational New Drug (pre-IND) meeting with the FDA, receiving feedback to support opening an IND for first-in-human trials of SPC-15, an intranasal treatment for PTSD and stress-induced anxiety. CEO Eric Weisblum stated that the company now has a clear path to clinical development, with plans to bring SPC-15 to market following FDA approval. Silo is currently conducting pharmacokinetic and pharmacodynamic studies as part of its ongoing ...

LOS ANGELES- Recent research suggests that the active ingredient in psychedelic mushrooms, psilocybin, may offer significant benefits for individuals struggling with depression, pending approval from the U.S. Food and Drug Administration (FDA). With roughly one in 10 American adults experiencing depressive illness annually, the potential for psilocybin therapy to alleviate symptoms has garnered increasing attention. Psilocybin has shown promise in treating major depressive disorder, with studies suggesting that just two doses could provide relief for up to a year. Although the FDA has not yet approved psilocybin-assisted therapy, several breakthrough therapy designations have been granted for its use in treatment-resistant depression. This condition affects individuals who have not responded to ...

LOS ANGELES- Mind Medicine (MindMed) Inc., a clinical-stage biopharmaceutical company focused on developing novel treatments for brain health disorders, announced its participation in three significant investor conferences in September 2024. MindMed’s management team will engage in discussions on the evolving role of psychedelics in psychiatry and brain health treatments. The company’s schedule includes: A panel discussion at the H.C. Wainwright Global Investment Conference on September 10. A fireside chat at Baird’s Global Healthcare Conference on September 11. A second fireside chat at the Cantor Global Healthcare Conference on September 17. All events will take place in New York, and audio webcasts of the presentations will be accessible through MindMed’s Investor ...

LOS ANGELES- Awakn Life Sciences Corp. announced the screening of its first patient for the Phase 3 trial of AWKN-001, a new treatment targeting severe Alcohol Use Disorder (AUD). The trial, known as MORE-KARE, represents a significant milestone in assessing the effectiveness of AWKN-001. AWKN-001 combines intravenous ketamine, an N-methyl-D-aspartate receptor modulator, with structured psycho-social support. The treatment aims to reduce heavy drinking days and improve overall outcomes for individuals with severe AUD. The MORE-KARE study, co-funded by the UK’s Medical Research Council (MRC), the National Institute for Health and Care Research (NIHR), and Awakn Life Sciences, will be conducted at eight NHS sites across the UK. The trial will ...

LOS ANGELES- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) announced a public offering aimed at raising $75 million through the sale of approximately 9.2 million shares at $7 each. The company is also offering around 1.4 million shares at a slightly discounted price of $6.99 to select investors. The offering is expected to close on August 12, with Leerink Partners and Evercore ISI acting as joint bookrunning managers. Proceeds from the offering will be used to support research and development for MindMed’s psychedelic treatments, particularly those in clinical trials targeting anxiety disorders. During its first-quarter earnings call in May, the company reported a cash reserve of $252.3 million, expected to sustain ...

LOS ANGELES- Mind Medicine (MindMed) Inc. announced a public offering aimed at raising $75 million through the sale of approximately 9.2 million shares at $7 each. The company is also offering around 1.4 million shares at a slightly discounted price of $6.99 to select investors. The offering is expected to close on August 12, with Leerink Partners and Evercore ISI acting as joint bookrunning managers. Proceeds from the offering will be used to support research and development for MindMed’s psychedelic treatments, particularly those in clinical trials targeting anxiety disorders. During its first-quarter earnings call in May, the company reported a cash reserve of $252.3 million, expected to sustain operations until ...

LOS ANGELES- Optimi Health, a GMP-approved and Health Canada-licensed psychedelics pharmaceutical manufacturer, has entered into a non-binding Letter of Intent (LOI) with Psyence Biomedical Ltd. . This partnership positions Optimi as the exclusive supplier of nature-derived (non-synthetic) psilocybin extract for Psyence's global drug development and commercialization efforts, particularly within the FDA-approved palliative care context. Under the terms of the LOI, Optimi will provide Chemistry, Manufacturing, and Control (CMC) support for Psyence’s regulatory submissions and any future Investigational New Drug (IND) applications. Psyence will secure exclusive rights to Optimi’s drug candidate for treatment use in palliative care. Optimi CEO Bill Ciprick highlighted the partnership’s potential to advance psilocybin-based therapies, while Psyence ...