Psychedelics

NEW YORK – Compass Pathways PLC ADR announced a new grant program inviting U.S.-based organizations to develop training content for healthcare providers who could deliver its investigational COMP360 psilocybin treatment if regulators approve it. The London-based biotechnology company, which maintains offices in New York, said the grants will support the creation of structured materials focused on foundational psychedelic care plus a dedicated module on COMP360. The program builds on training already provided by established organizations that have prepared thousands of providers in psychedelic-assisted approaches. Compass plans to work directly with selected recipients to refine the content as it readies sites of care for a possible commercial launch of the therapy ...

PHOENIX – The Ninth U.S. Circuit Court of Appeals has ruled that the federal government must reimburse the Church of the Eagle and the Condor and its members more than $2 million in attorney fees after a settlement that permits the group to import and use ayahuasca for religious ceremonies. The three-judge panel reversed a U.S. District Court decision in Arizona that had denied the fees, finding that the church qualified as the prevailing party under federal law once the government agreed to resolve the case. The unpublished memorandum opinion remanded the matter to District Judge Susan R. Bolton with instructions to award the fees and costs. The Church of ...

SANTA FE – Gov. Michelle Lujan Grisham signed the state’s annual budget bill, setting aside $630,000 to create the Medical Psilocybin Treatment Equity Fund and extend access to supervised psilocybin therapy for low-income and rural New Mexicans. The allocation appears in House Bill 2 and backs a provision written into the New Mexico Medical Psilocybin Act, which the Legislature passed in 2025. That law established a regulated program allowing qualified patients to receive psilocybin-assisted therapy for treatment-resistant depression (TRD), post-traumatic stress disorder (PTSD), substance use disorders, and end-of-life distress. The equity fund, housed in the state treasury, will help cover treatment costs for patients who meet income criteria set by ...

NEW YORK – Deutsche Bank AG has begun formal research coverage of AtaiBeckley Inc., the Nasdaq-listed biopharmaceutical company created from the merger of atai Life Sciences and Beckley Psytech. David Hoang, a senior equity research analyst at Deutsche Bank who focuses on publicly traded companies in the healthcare and biotech sectors, assigned a ‘Buy’ rating and a $12 price target to the AtaiBeckley stock. The research reflects the bank’s evaluation of the company's portfolio of investigational treatments for mental health conditions often resistant to standard therapies. AtaiBeckley’s programs include BPL-003, a nasal spray formulation of mebufotenin (5-MeO-DMT) for treatment-resistant depression (TRD), and VLS-01, a DMT-based buccal film designed for the ...

NEW YORK – Gilgamesh Pharma, the clinical-stage neuroscience company formed last year after AbbVie acquired its predecessor’s lead psychedelic-derived program, announced it had completed an oversubscribed $60 million Series A financing. The round was led by Satori Neuro and included participation from Prime Movers Lab, which backed earlier rounds of the original Gilgamesh Pharmaceuticals, along with other new and returning institutional investors. The proceeds will advance the company’s pipeline of proprietary neuropsychiatric candidates and expand its discovery platform. All programs are new chemical entities protected by composition-of-matter patents. Gilgamesh Pharma inherited its current assets from the 2025 AbbVie transaction, which acquired the $1.2 billion bretisilocin program [a short-acting 5-HT2A agonist ...

BRUSSELS – The European Medicines Agency (EMA) has granted Priority Medicines (PRIME) eligibility to bretisilocin, an investigational compound from AbbVie Inc. aimed at treating major depressive disorder (MDD). The decision adopted at the Committee for Medicinal Products for Human Use meeting positions the drug as the first psychedelic candidate to receive this designation. PRIME offers early and ongoing dialogue with regulators to streamline development for medicines that address unmet needs. It functions much like the FDA’s Breakthrough Therapy Designation but stops short of any approval guarantee. Psychiatry has seen limited use of the program compared with fields like oncology, where dozens of candidates have qualified over the years. Bretisilocin, a ...

BOSTON – Massachusetts lawmakers have advanced legislation that would set up pilot programs for regulated psychedelic therapy, with one measure clearing a key committee in September 2025 and related proposals still under review. The Senate Bill S.1400, sponsored by Sen. Cindy Friedman, won favorable approval from the Joint Committee on Mental Health, Substance Use and Recovery. It directs the Department of Public Health to license up to three specialized mental health clinics for supervised administration of psychedelic materials to treat conditions like depression, anxiety, PTSD, and substance use disorders. Clinics would operate under strict rules set by the department, including on-site delivery by multidisciplinary teams, patient screening and ongoing data ...

HONOLULU – The Hawaii Senate approved legislation that would set up a state task force to examine ways to bring breakthrough mental health treatments, like psilocybin- and MDMA-assisted therapies, into clinical and policy discussions. Senate Bill 3199, sponsored by Sen. Chris Lee (D), cleared the chamber on a unanimous 24-0 vote with one senator excused. The measure now heads to the House of Representatives, where it received first reading on March 10 and was referred to the committees on Health and Human Services and Finance. The bill establishes the Mental Health Emerging Therapies Task Force, which would operate for two years under an entity experienced in scientific research and medical ...

SAINT PAUL – A Minnesota House committee has cleared a measure to set up a limited program for psilocybin-assisted therapy, marking a significant step toward regulated access for adults facing certain mental health issues. Yesterday, the Health Finance & Policy Committee approved HF 2906 on a bipartisan voice vote, sending it next to the Commerce Finance & Policy Committee for review. Moderate partisan bill (Democrat 6-1) would reschedule psilocybin from Schedule I to Schedule IV in state law, acknowledging its potential medical value and lower risk profile. It creates a three-year pilot allowing up to 1,000 patients aged 21-plus with qualifying conditions like depression, PTSD, anxiety, substance use disorders, or ...

HARTFORD – Connecticut's Joint Committee on Public Health approved a bill that broadens the state's pilot program for psychedelic-assisted therapy, opening it to adults beyond just veterans and first responders. The measure, Senate Bill 191, clears the way for qualified patients to access MDMA or psilocybin treatments through FDA-approved research studies administered by a state medical school. The legislation strikes a prior requirement that the program end once the federal Drug Enforcement Administration approves MDMA and psilocybin for medical use. Instead, it mandates the Department of Mental Health and Addiction Services to run the initiative within available funds, focusing on clinical trials for those 18-plus who meet eligibility standards set ...

LOS ANGELES – Psychedelic Alpha, the data-focused research and analysis group that monitors the psychedelics sector, published its latest Bullseye Charts showing the state of drug development programs as of the first quarter of 2026. The charts present the pipeline in two formats. One displays the full spectrum of candidates from discovery through potential approval. The second focuses on assets in Phase 2 and later stages, grouped by broad therapeutic indications like depression, anxiety, post-traumatic stress disorder, and substance use disorders. Concentric rings mark each development stage, with the center reserved for approved products. The update reflects several corporate name changes that occurred in late 2025 and early 2026. MindMed ...

NEW YORK – A single intravenous dose of the psychedelic compound dimethyltryptamine (DMT), combined with psychological support, produced rapid and sustained reductions in depressive symptoms among adults with moderate-to-severe major depressive disorder, according to results from a small Phase 2a clinical trial. The study, published in Nature Medicine, involved 34 participants with treatment-resistant depression (TRD). Researchers from Imperial College London and collaborators conducted a double-blind, placebo-controlled trial in which participants received either a 21.5 mg dose of DMT fumarate (SPL026 by Helus Pharma Inc.) or placebo infused over 10 minutes. All received preparatory and integrative psychotherapy sessions. The primary endpoint was the change in Montgomery–Åsberg Depression Rating Scale (MADRS) scores ...

LONDON – Compass Pathways PLC ADR, a UK-based mental health biotech company, announced that its second Phase 3 trial met the primary endpoint in evaluating COMP360, a synthetic formulation of psilocybin, for treatment-resistant depression (TRD). The COMP006 study, which involved 581 participants across North America and Europe, tested two fixed 25 mg doses administered three weeks apart against a 1 mg control dose. At the six-week mark, the 25 mg group showed a mean difference of -3.8 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) compared with the control arm, with a p-value less than 0.001 and a 95% confidence interval of [-5.8, -1.8]. Thirty-nine percent of participants in the ...

CONCORD – The New Hampshire House of Representatives has given initial approval to a bipartisan measure that would establish a state program allowing supervised therapeutic access to psilocybin for qualifying medical conditions. House Bill 1809, sponsored by Rep. Buzz Scherr (D), cleared the chamber on a voice vote through its consent calendar. The legislation previously received unanimous support from the House Health, Human Services and Elderly Affairs Committee in a 18-0 vote late last month. The bill directs the Department of Health and Human Services (DHHS) to develop rules for a program providing psilocybin in controlled, medically supervised settings. It creates an advisory board to review clinical data, monitor patient ...

SYDNEY – Bioxyne Limited, an Australian life sciences and wellness products company, has received its first commercial orders for GMP-manufactured psilocybin capsules through its subsidiary Breathe Life Sciences (BLS). The capsules, branded BLSPSIL25, are intended for investigational use in addressing treatment-resistant depression, as well as exploratory research into other mental health conditions like anxiety and substance use disorders, and PTSD. The initial orders cover 250 doses, sufficient to support treatment for about 60 patients over the next 12 months. Supplies are going to authorized prescribers in Queensland and Western Australia under Australia's Therapeutic Goods Administration (TGA) Authorised Prescriber pathway. This follows the company's 2024 achievement as the first [and for ...

WASHINGTON D.C. – The recent introduction of bipartisan legislation in the U.S. House of Representatives has drawn attention to Clearmind Medicine Inc.'s proprietary compound MEAI as part of efforts to broaden veterans' access to certain emerging therapies. Clearmind announced that MEAI was explicitly named in H.R. 7091, the Expanding Veterans’ Access to Emerging Treatments Act of 2026. The bill directs the Department of Veterans Affairs to set up programs for investigational research and extended access to innovative treatments addressing unmet needs among veterans, particularly for conditions such as alcohol use disorder and PTSD. Alongside MEAI, the legislation lists psilocybin, MDMA, 5-MeO-DMT, ibogaine, ketamine, and other compounds that the VA secretary ...

CHARLESTON–JACKSON – Lawmakers in West Virginia and Mississippi have advanced legislation to support research into ibogaine, a psychedelic compound derived from the iboga plant, with the goal of pursuing FDA approval for its use in treating opioid use disorder and related conditions. In West Virginia House Bill 4626 established a grant program to fund public-private partnerships for FDA drug development trials of ibogaine. The measure passed the House of Delegates unanimously (96-0) on February 1, 2026, and has moved to the Senate for further consideration. The bill directs the Secretary of Health to administer grants aimed at securing investigational new drug status and breakthrough therapy designation from the FDA. Additionally, ...

PORTLAND – The Psychedelic Pharmacists Association (PPA) has launched the Psychedelic Pharmacists Foundation (PPF), a new nonprofit entity focused on education, research, and public awareness of responsible psychedelic medicine integration. The PPF will operate as a sister organization to the PPA, which has served as a professional community for pharmacists and allies interested in the therapeutic use of psychedelics since its establishment. The PPA describes itself as the leading nonprofit devoted to pharmacists advancing psychedelics as medicines, with efforts centered on advocacy, education, and collaboration in clinical settings. According to the announcement shared across the PPA's social channels, the PPF will function as a dedicated home for psychedelic educational initiatives. ...

LOS ANGELES – A new survey from the RAND Corporation reveals that roughly 10 million adult Americans turned to microdosing psychedelics last year, taking sub-perceptual amounts of substances like psilocybin, LSD or MDMA to manage daily stresses or boost focus. The estimate, drawn from a nationally representative poll of 10,122 respondents, underscores an expansion in non-clinical use as federal and state regulators weigh paths forward for these compounds. Conducted in September 2025 through the AmeriSpeak panel managed by NORC at the University of Chicago, the 2025 RAND Psychedelics Survey weighted responses to mirror the nation's 259 million adults. It tracked self-reported consumption of 11 psychedelics over the prior 12 months, ...

WASHINGTON – A fresh survey reveals that a majority of Americans express interest in gaining more knowledge about psychedelics as potential tools for mental healthcare, even as public familiarity remains spotty and opinions split along demographic lines. The poll, conducted last Fall by Ipsos in partnership with Psychedelic Alpha, underscores readiness among respondents to engage with the topic. At its core, the study, based on responses from 1,022 U.S. adults surveyed online, probes how information flows to the public and shapes views on psychedelic compounds. Awareness is low. Seven in 10 Americans report encountering no news coverage on the subject in the prior three months. When exposure does occur, it ...

TRENTON – The New Jersey Legislature gave final approval last week to a measure that sets up a state-backed pilot program for psilocybin therapy, allocating $6 million to explore the compound's role in treating mental health conditions. The bill, S2283, now heads to Gov. Phil Murphy's desk for his expected review in the coming weeks. Lawmakers in the Assembly passed the legislation on Jan. 12 by a 48-23 margin, following swift Senate concurrence the same day in a 35-4 vote. Sponsored by Senate President Nicholas Scutari, a Democrat from Union County, the bill directs the state Department of Health to oversee an 18-month rollout, including licensing for manufacturers, testing labs, ...

NEW YORK – Mind Medicine (MindMed) Inc., a developer of treatments derived from psychedelics for mental health conditions, has changed its name to Definium Therapeutics Inc., a move that underscores its push into late-stage testing for anxiety and depression therapies. The company, which will begin trading under the Nasdaq symbol $DFTX on January 15, expects results from three Phase 3 studies of its lead LSD formulation in 2026, a step that could clarify the commercial path for such compounds in mainstream medicine. The rebranding comes as Definium readies submissions to the Food and Drug Administration (FDA) for its flagship product, DT120 [formerly MM120], an orally disintegrating tablet version of lysergic ...

TORONTO – Helus Pharma Inc., rebranded from Cybin Inc., opened trading on the Nasdaq Global Market under the ticker symbol $HELP, marking a shift from the NYSE American where it previously traded as $CYBN. The transition followed the company's last day on the NYSE American the prior Friday, a step designed to broaden its investor base in the competitive biotech arena. Based on company statements, the name change from Cybin to Helus Pharma underscores a deliberate shift toward the late-stage development of treatments targeting mental health disorders. Founded in 2019, the firm has built a portfolio around novel serotonergic agonists – molecules that stimulate serotonin receptors to foster brain plasticity ...