Psychedelics

NEW YORK – Definium Therapeutics Inc. has released topline results from the first of two Phase 3 studies testing its LSD-based candidate DT120 in adults with generalized anxiety disorder (GAD). The findings add to earlier Phase 3 data in major depressive disorder. In the Voyage trial, a single 100-microgram dose of DT120 orally disintegrating tablet met the primary endpoint and all key secondary endpoints. Participants who received the drug showed a least-squares mean reduction of 11.6 points on the Hamilton Anxiety Rating Scale (HAM-A) at Week 12, compared with a 6.2-point reduction for those on placebo. The placebo-adjusted difference of 5.4 points was statistically significant (p<0.0001), with a Cohen’s d ...

SAN JUAN – Puerto Rico’s governor has directed the territory’s health department to examine the practical steps needed to advance clinical research into emerging therapies, including certain psychedelic compounds. The move positions a commonwealth to explore regulated trials aimed at serious mental health and substance-use challenges. Governor Jenniffer González-Colón signed Executive Order 2026-037, instructing the Secretary of the Department of Health to assess the feasibility of a Pilot Clinical Research Program for Emerging Therapies. The order defines emerging therapies to include psychedelic approaches and ibogaine, along with compounds like psilocybin and MDMA that remain under investigational status. The directive prioritizes work that could benefit veterans and other groups facing complex ...

SILVER SPRING – The FDA published its final guidance titled "Psychedelic Drugs: Considerations for Clinical Investigations" in the Federal Register, finalizing a draft that first appeared in June 2023. Issued by the Center for Drug Evaluation and Research, the document gives sponsors general considerations for developing compounds including psilocybin, LSD, and MDMA as treatments for psychiatric disorders and substance use disorders. Drug development programs in this category are subject to the same regulations and evidentiary standards as any other investigational product. Where the guidance breaks new ground is in its treatment of a problem structurally embedded in every psychedelic trial: functional unblinding. Functional unblinding occurs when participants in a supposedly ...

LOS ANGELES – Q2 2026 gave the psychedelic medicine sector the quarter that practitioners, investors, and regulators had been building up for years. Clinical programs delivered Phase 3 results, the White House signed an executive order, and the FDA cleared its first ibogaine-derived compound for U.S. study. Together, the three months ending June 30 produced a degree of institutional progress the sector has rarely seen in a single window. The quarter's most closely tracked result arrived June 22, when Definium Therapeutics (formerly MindMed) announced positive topline data from the Phase 3 Emerge study of DT120, its proprietary lysergide orally disintegrating tablet, in major depressive disorder. The single-dose trial met its ...

NEW YORK – Helus Pharma, the business name now used by Cybin Inc., announced that enrollment in its APPROACH Phase 3 trial has passed the 86% mark. The trial is testing HLP003, the company's lead drug candidate, as an add-on treatment for major depressive disorder (MDD) in patients who have not fully responded to standard antidepressants. With recent business highlights and fiscal year 2026 financial results announced, Helus reported that the study is still on schedule for a topline data readout in Q4 2026. This timeline has been maintained since HLP003, the company’s proprietary novel serotonergic agonist (NSA), received Breakthrough Therapy Designation from the FDA. That designation, reserved for drugs ...

NEW YORK – Definium Therapeutics Inc. announced positive topline data from its Phase 3 Emerge study evaluating DT120, an orally disintegrating tablet (ODT) formulation of pharmaceutical LSD, in adults with major depressive disorder (MDD). The results highlight notable improvements in depression symptoms after a single dose, adding to the growing body of research on psychedelics in mental health treatment. The double-blind, placebo-controlled trial enrolled 149 adults who were randomized to receive a single dose of DT120 or placebo over 12 weeks, with participants ranging from 18 to 74 years old across 20 study sites, each carrying a confirmed diagnosis of MDD. On the trial's main measure, the Montgomery-Åsberg Depression Rating ...

PRINCETON – Otsuka America, the U.S. subsidiary of Otsuka Pharmaceutical Co., Ltd., announced that it has completed its acquisition of Transcend Therapeutics, a New York biotechnology company developing rapid-acting treatments for neuropsychiatric disease. First disclosed in March, the deal makes Transcend a wholly owned subsidiary of Otsuka America and folds the company's lead candidate, TSND-201, into one of the world's larger privately held pharmaceutical portfolios. Per official release, Otsuka paid $700 million to Transcend shareholders at closing, with up to $525 million more available in contingent payments tied to future commercial sales milestones, bringing total potential consideration to roughly $1.225 billion. TSND-201 is Transcend's proprietary formulation of methylone, engineered without ...

RALEIGH – NC Lawmakers from both parties held a press conference at the General Assembly to support legislation that would direct state funding toward research on psilocybin, MDMA, and ibogaine as treatments for PTSD and related conditions. Rep. Allen Chesser (R), a former Army National Guard turret gunner who completed more than 100 combat missions in Iraq, told reporters he still fights battles he brought home with him. He said the country continues to lose veterans to suicide at an alarming daily rate and warned that sticking with the same treatment approach guarantees the same losses. The legislation, known as the Healing through Evidence-based Access to Lifesaving Care (HEAL) Act, ...

VANCOUVER – Optimi Health Corp. announced it has completed its first export of naturally derived psilocybin to the United Kingdom, with the material earmarked for a planned Phase 2 clinical trial whose partner and therapeutic indication have not yet been disclosed. The shipment includes psilocybin biomass and finished 5mg capsules – the same formulation currently prescribed to patients in Australia for treatment-resistant depression (TRD). It was manufactured at Optimi's GMP facility in Princeton, British Columbia, and cleared under export authorization from Health Canada and import authorization from the UK Home Office. That dual authorization matters. Psilocybin remains a Schedule I substance in the UK, placing it among the most tightly ...

BIRMINGHAM – For the first time, a peer-reviewed, randomized clinical trial showed that psilocybin significantly reduced cocaine use when combined with structured psychotherapy. The findings, published in JAMA Network Open by researchers at the University of Alabama at Birmingham, are drawing attention across addiction medicine for a simple reason: No medications have ever been proven effective for treating cocaine use disorder. Until now. The study enrolled 40 adults actively struggling with cocaine dependence and genuinely motivated to quit. Participants who received a single dose of psilocybin combined with psychotherapy recorded significantly more cocaine-free days over the following six months compared to those given a placebo. They were also far less ...

NEW YORK – Definium Therapeutics Inc. has taken another step forward in its late-stage testing of a psychedelic-derived treatment for major depressive disorder. The company announced that the first participant received a dose in the Ascend study, its second Phase 3 trial of DT120 ODT. DT120 ODT is Definium’s proprietary orally disintegrating tablet formulation of lysergide tartrate, a pharmaceutical version of LSD. The drug belongs to the class of serotonergic psychedelics and acts as a partial agonist at serotonin 2A receptors. It uses fast-dissolve technology aimed at providing faster absorption, better bioavailability, and fewer gastrointestinal side effects compared with traditional forms. The Ascend trial is a randomized, double-blind, placebo-controlled study ...

WASHINGTON – A bipartisan coalition of 32 House members sent a formal letter to FDA Commissioner Martin A. Makary urging the agency to move faster on ongoing reviews of psychedelic treatments. The letter stated that "for many individuals, current treatment options remain insufficient, deepening an already urgent public health crisis," and referenced veterans, clinicians, and families as constituencies directly affected by the lack of approved alternatives. The congressional letter arrives weeks after a significant executive action from the White House. On April 18, 2026, President Trump signed an executive order directing federal agencies to accelerate development and potential approval of psychedelic-based therapies for conditions including PTSD, depression, and substance use ...

BALTIMORE – Researchers at Johns Hopkins University have published findings from a pilot randomized clinical trial that points to potential advantages of psilocybin-assisted therapy over standard nicotine replacement for helping adults quit cigarettes. Published in JAMA Network Open, the study compared nicotine patches to psilocybin as smoking cessation tools. At the six-month mark, participants who received just one dose of psilocybin had more than six times greater odds of remaining cigarette-free than those who relied on the nicotine substitute. The trial, led by Dr. Matthew Johnson, a professor of psychiatry at Johns Hopkins, enrolled 82 adult smokers who had a mean age of about 48, reported a median of six ...

NEW YORK – Helus Pharma, a clinical-stage biopharmaceutical company focused on developing novel serotonergic agonists (NSAs) to treat mental health conditions, announced it has joined forces with TARA Mind to help recruit veterans for its Phase 3 trial of an experimental treatment for major depressive disorder (MDD) and to broaden mental health support in military communities. The agreement brings together Helus Pharma’s PARADIGM HLP003 program and the networks of TARA Mind, which partners with Veterans Exploring Treatment Solutions (VETS). The groups plan to connect veterans with information about the ongoing trial and raise awareness of new research options for conditions like depression that affect service members at high rates. HLP003 ...

NEW YORK – AtaiBeckley Inc., the clinical-stage biopharmaceutical firm born from the November merger of atai Life Sciences and Beckley Psytech, released additional results from its exploratory Phase 2a trial of EMP-01, an oral formulation of R-MDMA, in adults with moderate to severe social anxiety disorder (SAD). The study, conducted at seven sites in the United Kingdom, enrolled 71 participants who received two 225-milligram doses of the drug or placebo, administered 28 days apart in a clinic setting without any accompanying psychotherapy. The trial met its primary goal of demonstrating safety and tolerability, with no serious adverse events reported and most side effects described as mild to moderate and self-resolving. ...

WASHINGTON – President Donald Trump signed an executive order directing federal agencies to speed up reviews of certain psychedelic compounds and open new pathways for patient access as treatments for serious mental health disorders like severe depression, PTSD, and addictions that resist standard therapies. The order, formally titled “Accelerating Medical Treatments for Serious Mental Illness,” instructs the Food and Drug Administration (FDA) to issue Commissioner’s National Priority Vouchers for psychedelic drugs that already hold Breakthrough Therapy designations. It also calls on the FDA and Drug Enforcement Administration (DEA) to create a process allowing eligible patients to obtain investigational psychedelics [with ibogaine compounds highlighted] under the Right to Try Act once ...

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 ...