Psychedelics

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 ...

WASHINGTON – The Drug Enforcement Administration has approved expanded production limits for key psychedelics, setting the stage for increased scientific inquiry into substances like psilocybin and DMT next year. In a final order published Monday in the Federal Register, the agency established aggregate quotas at levels above its initial proposals, responding to demands from researchers and manufacturers. Under the new rules, psilocybin will see its annual production cap rise to 50,000 grams, up from 40,000 grams outlined in November's proposal and a marked increase from the 30,000 grams allowed in 2025. Psilocyn, a related Schedule I substance, gets an even sharper boost to 80,000 grams, more than double the prior ...

LONDON – Compass Pathways plans to hold a virtual webinar to outline its steps toward launching a psilocybin-based therapy for treatment-resistant depression (TRD) and to share details on upcoming trials for post-traumatic stress disorder (PTSD). The session will feature discussions from medical experts and industry executives on current challenges in treating these conditions, including care delivery models and economic factors for providers. Participants include: Gary Small, MD, Chair of Psychiatry at Hackensack University Medical Center, Geoff Grammer, MD, CMO at Greenbrook Mental Wellness Centers, Myriam Barthes, co-founder and CEO at Journey Clinical, and Dimitri Cavathas, CEO at HealthPort. Compass Pathways' lead candidate, COMP360, a synthetic form of psilocybin, received breakthrough ...

NEW YORK – AtaiBeckley N.V., the clinical-stage biopharmaceutical firm born from the November merger of atai Life Sciences and Beckley Psytech, has secured a place in the Nasdaq Biotechnology Index (NBI), a move that underscores its rising profile in mental health innovation. The addition follows shareholder approval for the company's redomiciliation to Delaware, a process set to finalize by year's end. This dual development positions AtaiBeckley to tap into deeper pools of U.S. institutional capital. Index inclusion often triggers automatic purchases from exchange-traded funds and mutual funds tracking the NBI, which holds about 200 biotech names selected for factors like market cap and trading volume. Shares of AtaiBeckley (NASDAQ: ATAI) ...

AUSTIN – The Texas Health and Human Services Commission has granted $50 million to a statewide consortium led by UTHealth Houston and the University of Texas Medical Branch at Galveston, marking the formal launch of clinical trials for ibogaine, a psychoactive compound derived from an African shrub. The two-year initiative, dubbed Ibogaine Medicine for PTSD, Addiction, and Cognitive Trauma (IMPACT), will test the substance's effects on opioid dependence, post-traumatic stress disorder (PTSD), and traumatic brain injuries (TBIs), conditions that disproportionately affect the state's 1.7 million veterans and serving military members. The funding stems from Senate Bill 2308, signed into law by Gov. Greg Abbott in June, which authorized the creation ...

PRAGUE – The Czech Republic has taken a measured step toward integrating psychedelic-assisted therapy into its healthcare system, approving detailed rules that will permit the controlled use of psilocybin for select patients beginning in January 2026. This development, rooted in a recent amendment to the nation's criminal code, positions the country as Europe's early adopter of such treatments, with administration confined to qualified psychiatrists addressing severe, unresponsive depression. The government's decree outlines precise protocols for psilocybin's application in cases of treatment-resistant depression, cancer-linked mood disorders, and other life-threatening mental health crises where conventional medications prove ineffective. Only synthetic psilocybin, prepared as custom compounded drugs, qualifies under the rules, capping usage ...

SANTA FE – State health leaders in New Mexico outlined plans this week to open a regulated psilocybin therapy program by the close of 2026, advancing the timeline a full year from the original statutory target. The move, shared during the inaugural session of the Medical Psilocybin Advisory Board, reflects strong public demand and positions the state as an early adopter in the growing field of guided psychedelic treatments. Dominick Zurlo, who directs the Department of Health's Center for Medical Cannabis and Psilocybin, told board members that officials aim to treat the first patients by December 31, 2026. "There has been such large interest in this and a push for ...

LOS ANGELES – The Food and Drug Administration is preparing to overhaul its evidence requirements for new drug approvals, making a single well-designed Phase 3 trial the standard rather than the exception. This adjustment, outlined by agency Commissioner Marty Makary, could streamline paths to market for therapies in mental health, including experimental psychedelic treatments for post-traumatic stress disorder (PTSD), depression, and anxiety. Makary emphasized the scientific foundation for the change. "You can achieve the same statistical power with one trial as you would with two trials when it’s designed and controlled appropriately," he said. The policy update, expected within three to six months, builds on existing flexibility. In 2024, 66% ...

LOS ANGELES – Federal health officials under the Trump administration have begun to signal stronger backing for psychedelic therapies, setting the stage for possible FDA approvals of MDMA and psilocybin treatments within the next 18 months, according to recent conversations with regulators, lawmakers, and industry executives. This shift comes as developers ramp up lobbying efforts and states introduce dozens of reform measures, though persistent concerns over clinical trial integrity continue to test the sector's progress. Health and Human Services Secretary Robert F. Kennedy Jr. has taken a direct role in championing these substances, testifying before Congress in June that his department aims to enable clinical access to psychedelic options for ...

WASHINGTON – A group of House and Senate lawmakers from both parties unveiled legislation to permit physicians to deliver Schedule I substances, including MDMA and psilocybin, to individuals grappling with terminal illnesses or severe mental health disorders. The Freedom to Heal Act, sponsored by Senators Cory Booker (D-N.J.) and Rand Paul (R-Ky.) alongside Representatives Madeleine Dean (D-Pa.) and Nancy Mace (R-S.C.), would carve out an exemption in the Controlled Substances Act to align these treatments with the existing federal Right to Try framework. Under the proposal, eligible patients [those who have exhausted standard FDA-approved options] could receive supervised administration of investigational therapies after a Phase 1 clinical trial demonstrates basic ...

NEW YORK – Psyence BioMedical Ltd. disclosed its entry into longevity science with a new program probing psilocybin's influence on key aging indicators. The initiative, conducted alongside South African academics, marks the company's first foray beyond mental health applications and establishes it as the sole public firm pursuing this angle on the Schedule I substance. At its core, the project deploys an accelerated preclinical framework to track shifts in cellular stress, inflammatory responses, mitochondrial efficiency, and telomere length following psilocybin exposure. Early lab work underpinning the effort points to psilocin [the compound's active form] prolonging survival rates in elderly rodents and boosting the viability of human skin and lung cells ...

TRENTON – New Jersey lawmakers advanced a bill that would allow supervised access to psilocybin for adults facing certain health challenges, establishing a regulated psilocybin therapy framework approved by the Assembly Health Committee. Assemblymember Anthony Verrelli, a Democrat and co-sponsor of the measure, framed the legislation during testimony as a targeted response to unmet mental health needs. "This bill gives another option for people to heal and get better," Verrelli said. "And by getting them better, it gives them the opportunity to make their communities, their families, and life in general better to break that cycle of trauma, however it looks." The bill, designated A3852 in the Assembly and S2283 ...

BERLIN – Switzerland's long-standing framework for psychedelic treatments has set a course for its neighbors, as Germany and the Czech Republic roll out their own programs to address stubborn mental health conditions. These steps mark a cautious expansion of therapies using psilocybin, with Switzerland also permitting limited use of LSD and MDMA, signaling a shift toward regulated access across the region. In Switzerland, the Federal Office of Public Health issued 723 authorizations for psychedelic-assisted therapy in 2024 alone [348 for psilocybin, 245 for MDMA, and 130 for LSD] administered by roughly 100 licensed physicians at 80 private practices and 15 institutions, including university hospitals. This builds on a program dating ...

CHICAGO – AbbVie Inc. disclosed in a recent securities filing that it handed over $900 million in cash at the outset of its acquisition of bretisilocin, the experimental psychedelic compound acquired from Gilgamesh Pharmaceuticals aimed at treating major depressive disorder (MDD). The revelation, uncovered in the company's Q3 2025 report, fills in a key blank from the $1.2 billion transaction announced in August and closed last month, showing that three-quarters of the value flowed immediately to the seller. That cash portion exceeds what deal watchers had anticipated for a Phase 2 asset in the nascent field of psychedelic medicines, where upfront payments often hover below 50% to hedge against clinical ...

LONDON & NEW YORK – Compass Pathways reported Q3 2025 financial results and signaled a faster path to market for its lead psilocybin-based therapy in treatment-resistant depression (TRD). The biotechnology firm now targets commercialization readiness 9 to 12 months ahead of schedule, a shift driven by completed enrollment in its second Phase 3 trial and encouraging feedback from U.S. regulators. The update comes as Compass wraps up the COMP006 study, which enrolled 585 patients to evaluate a single dose of COMP360 psilocybin therapy paired with psychological support. This follows positive topline results from the first Phase 3 trial, COMP005, in June, where the treatment showed statistically significant symptom reductions at ...