The first quarter of 2026 delivered the data the sector spent years waiting for. Compass Pathways achieved a positive primary endpoint in its second pivotal Phase 3 psilocybin trial — becoming the first company with two positive Phase 3 readouts in treatment-resistant depression — and promptly raised $150 million. GH Research opened the year with its FDA clinical hold lifted and a JAMA Psychiatry publication, and a second Big Pharma-scale deal landed as Otsuka agreed to acquire methylone developer Transcend Therapeutics for up to $1.225 billion.
This report covers the quarter's clinical breakthroughs, the corporate rebrands that reshaped the sector's most-watched names, and the policy momentum building at the state and federal level.
Index Performance
The Psychedelic Invest Index (GPI) gained +25.6% across the first quarter of 2026, moving from 178.7 on 2025-12-31 to 224.4 on 2026-03-31. It ranged from an intraperiod low of 178.4 (2026-01-02) to a high of 225.3 (2026-02-18). Track the live index and its constituents on our Stock Index page.
Clinical & Pipeline Milestones
The engine of the sector remains its clinical readouts. Here are the trial results, regulatory designations, and pipeline milestones that moved the needle this period.
GH Research PLC (GHRS). GH Research announced the FDA lifted the clinical hold on its Investigational New Drug application for GH001, its inhaled 5-MeO-DMT candidate for treatment-resistant depression, allowing U.S. patient enrollment to proceed. The resolution — following months addressing IND hold topics with no findings of respiratory toxicity — clears the way for a planned global pivotal Phase 3 program in 2026. GH Research held roughly $294 million in cash as of September 30, 2025, and its Phase 2b trial had shown a 73% six-month remission rate.
Compass Pathways plc (CMPS). Compass Pathways said the FDA accepted its Investigational New Drug application for COMP360 psilocybin in PTSD, enabling initiation of a Phase 2b/3 study (COMP202) in patients with PTSD. Alongside the acceptance, management hosted a webinar with clinical and industry experts on its PTSD plans and commercial preparations for treatment-resistant depression, expanding the psilocybin franchise into a second major psychiatric indication as the company moves toward a rolling NDA submission in TRD.
Compass Pathways plc (CMPS). STAT reported that senior HHS and White House officials blocked FDA Commissioner Marty Makary's plan to grant COMP360 psilocybin a Commissioner's National Priority Voucher, which promised a compressed 1-2 month review; of ten proposed drugs, psilocybin was the only one vetoed. COMP360 retained its Breakthrough Therapy Designation and rolling-review eligibility, so the core approval pathway was intact, but the episode signaled political sensitivity around psychedelics. The decision was later reversed in April 2026 when the FDA did issue Compass a priority voucher.
Clearmind Medicine Inc. (CMND). Clearmind Medicine announced additional topline safety results from the second cohort of its Phase I/IIa trial of CMND-100, a non-hallucinogenic oral candidate for alcohol use disorder, reporting no serious adverse events and good tolerability after six additional patients completed treatment. The multinational study is run with partners including Yale and Johns Hopkins. The favorable safety profile positioned the program to advance to its next stage.
Compass Pathways plc (CMPS). Compass Pathways announced that its Phase 3 COMP006 trial met its primary endpoint, with two fixed 25 mg doses of COMP360 psilocybin showing a highly statistically significant MADRS reduction versus a 1 mg comparator (difference of -3.8 points, p<0.001) at the Week 6 endpoint. The company also released 26-week durability data from its first Phase 3 (COMP005), making COMP360 the first psilocybin therapy with two positive pivotal readouts in treatment-resistant depression. Compass reiterated plans to complete a rolling NDA submission in Q4 2026, and psychedelic stocks broadly rallied on the news.
Reunion Neuroscience. Privately held Reunion Neuroscience said the FDA granted Breakthrough Therapy Designation to luvesilocin (formerly RE104), a subcutaneous prodrug of the psilocybin-like compound 4-OH-DiPT, for postpartum depression. The designation followed Phase 2 RECONNECT data in which 70% of patients on the 30 mg dose reached remission by Day 7, sustained through Day 28. Reunion expects to begin a pivotal Phase 3 PPD trial in 2026, adding another psychedelic-derived asset to the FDA's expedited-review roster.
AtaiBeckley Inc. (ATAI). AtaiBeckley announced topline results from an exploratory, placebo-controlled Phase 2a study of EMP-01, its oral R-MDMA candidate, in 71 adults with moderate-to-severe social anxiety disorder. The study met its primary safety objective and showed a placebo-adjusted 11.85-point reduction on the Liebowitz Social Anxiety Scale at Day 43 (p=0.036, one-tailed), with 49% CGI-I responders versus 15% on placebo, achieved without adjunctive psychotherapy. The data support continued development of oral R-MDMA and add to AtaiBeckley's multi-asset psychedelic pipeline.
Definium Therapeutics, Inc. (DFTX). In its first annual report under the new name, Definium Therapeutics reported $411.6 million in cash and investments as of year-end 2025, a runway it said funds operations into 2028. The company confirmed its Emerge Phase 3 MDD trial is fully enrolled (topline expected late Q2 2026), Voyage (GAD) is roughly 80% enrolled (early Q3 2026), and Panorama (GAD) enrollment is on track for a 2H 2026 readout. Management framed 2026 as a pivotal year with three Phase 3 topline readouts for its optimized-LSD lead DT120.
Clearmind Medicine Inc. (CMND). Clearmind Medicine said its independent Data and Safety Monitoring Board reviewed the accumulated safety data and cleared the CMND-100 Phase I/IIa alcohol-use-disorder trial to proceed to its next stage. The decision followed the positive second-cohort safety results reported in February. Advancing past the DSMB checkpoint keeps the non-hallucinogenic MEAI-based candidate moving through early clinical development.
Numinus Wellness Inc. (NUMI). Numinus Wellness provided a corporate update detailing its strategic transformation into two core segments — its clinical trial site network (Cedar Clinical Research) and its practitioner-training platform — after selling its U.S. wellness clinics and winding down non-operating subsidiaries. The company said its sites have supported more than 20 psychedelic clinical studies and that it has trained over 2,500 practitioners, including 800+ research therapists. The pivot repositions Numinus as an infrastructure and services provider to drug developers rather than a clinic operator; days later the TSX moved to delist its shares, pushing it toward the CSE.
Compass Pathways plc (CMPS). Compass Pathways reported fourth-quarter and full-year 2025 results, with 2025 R&D expense roughly flat at $118.4 million and G&A of $60.6 million. The company said a February financing of about $150 million plus roughly $200 million from warrant exercises pushed its cash runway into 2028. Management pointed to an upcoming FDA meeting to confirm its NDA strategy for COMP360 psilocybin and reiterated a goal of being launch-ready by the end of 2026.
GH Research PLC (GHRS). GH Research announced that full results from its randomized, placebo-controlled Phase 2b trial of inhaled mebufotenin (GH001, a 5-MeO-DMT formulation) in treatment-resistant depression were published in JAMA Psychiatry. The peer-reviewed data reinforced a rapid, large treatment effect one week after dosing, and the company highlighted a new finding that efficacy appeared independent of the number of prior antidepressant failures. The publication supports GH Research's push toward a global Phase 3 program in TRD.
Policy, Regulation & Access
Psychedelic policy accelerated on multiple fronts — federal, state, and international. These developments shape the demand-side runway for every developer we track.
State of New Jersey (policy). Outgoing Governor Phil Murphy signed legislation establishing a state-run, hospital-based psilocybin research and therapy pilot program, appropriating $6 million split across three New Jersey hospitals (north, central and south). The bill also creates an 11-member Psychedelic Therapy and Research Advisory Board to oversee the two-year program, with trials designed to align with FDA study protocols. The signing added New Jersey to a growing list of states building regulated psilocybin access pathways ahead of any federal approval.
PharmAla Biotech Holdings Inc. (MDMA). PharmAla Biotech signed a supply-and-data agreement with Nautilus Sanctuary to provide LaNeo MDMA for an open-label Phase 2 U.S. trial of MDMA-assisted therapy in frontline healthcare workers and first responders with post-traumatic stress and adjustment disorder. In exchange, PharmAla receives a perpetual, non-exclusive license to the trial data for regulatory and commercial use in any jurisdiction. The structure lets PharmAla accumulate clinical data assets while supplying drug product.
U.S. Senate (policy). Senators Ruben Gallego (D-AZ) and Dave McCormick (R-PA) introduced the bipartisan Innovative Therapies Centers of Excellence Act, which would direct the VA to designate at least five research centers studying MDMA, ibogaine, ketamine and psilocybin for conditions including PTSD, depression and substance use disorder in veterans. Companion House legislation was also filed. The bill reflects mounting federal momentum, alongside a Trump executive order, to expand veteran access to psychedelic therapies — an important demand-side signal for developers.
State of Mississippi (policy). Governor Tate Reeves signed the Ibogaine Drug Development Clinical Trial Act, appropriating roughly $5 million to help fund clinical research aimed at winning FDA approval of ibogaine. The law directs Mississippi's research consortium to coordinate with, and use the same drug developer as, a lead consortium in another state, effectively tying its effort to Texas's larger ibogaine program. The move adds to a fast-growing wave of state-level psychedelic research funding.
Capital Markets, M&A & Corporate
Financings, listings, and dealmaking tell you where conviction is flowing. This is how the sector's balance sheets and corporate structures shifted.
Helus Pharma (formerly Cybin Inc.) (HELP). The company formerly known as Cybin commenced trading on the Nasdaq Global Market under the ticker HELP, doing business as Helus Pharma after its shares stopped trading on NYSE American on January 2. The uplisting completes the transition announced in December and positions the clinical-stage developer of CYB003 (depression) and CYB004 (anxiety) alongside a larger biopharma peer group as it approaches multiple 2026 data readouts.
Definium Therapeutics, Inc. (formerly MindMed) (DFTX). Mind Medicine (MindMed) relaunched as Definium Therapeutics, a new corporate name and brand identity meant to distance the company from its 2021 'shroom-stock' vintage and reframe it as a rigorous late-stage psychiatry developer. Management emphasized a pipeline led by DT120 ODT (its optimized LSD/lysergide tartrate), with three Phase 3 readouts across major depressive disorder and generalized anxiety disorder expected during 2026. The move made Definium the second advanced psychedelic drug developer to rebrand in early 2026, after Cybin became Helus Pharma days earlier.
Definium Therapeutics, Inc. (formerly MindMed) (DFTX). Following the corporate rebrand, the company's common shares began trading on Nasdaq under the new symbol DFTX, replacing MNMD. The ticker change completed the transition to the Definium Therapeutics identity for investors. The rebrand carried over the existing share structure with a one-for-one continuation.
Optimi Health Corp. (OPTI). Optimi Health, a Health Canada-licensed GMP manufacturer, completed its first 2026 production cycle of 1,000 MDMA capsules (60 mg) and 1,000 naturally derived psilocybin capsules (5 mg) destined for Australia under that country's Authorised Prescriber Scheme. The batch reinforces Optimi's role as a commercial supplier feeding Australia's regulated psychedelic-assisted therapy market, including insurer-backed programs. The run demonstrates ongoing revenue-generating drug supply while many peers remain pre-commercial.
Psyence Biomedical Ltd. (PBM). Psyence Biomedical implemented a previously delayed 1-for-6.25 reverse share consolidation, a step aimed at supporting its Nasdaq listing compliance and share price. The palliative-care-focused psilocybin developer continued advancing its NPX-5 program for adjustment disorder in cancer patients. Reverse splits were a recurring theme among small-cap psychedelic names navigating exchange minimum-price rules in early 2026.
Compass Pathways plc (CMPS). Capitalizing on its positive Phase 3 readouts, Compass priced a public offering of 17.5 million American Depositary Shares at $8.00 each, plus pre-funded warrants, for expected gross proceeds of about $150 million (before a 30-day over-allotment option for up to ~2.8 million more ADSs). Proceeds are earmarked for its ongoing COMP005/COMP006 trials, a Phase 2b/3 PTSD study, and commercial-readiness activities. The raise strengthened Compass's balance sheet ahead of its planned regulatory filing.
PharmAla Biotech Holdings Inc. (MDMA). PharmAla Biotech signed a binding agreement to supply LaNeo 40 mg MDMA capsules to Amsterdam University Medical Center for a planned clinical trial, bundled with a three-year stability-testing program for its single-capsule format. The company said the new stability data will support commercial-grade blister packaging for its LaNeo MDMA line. The deal extends PharmAla's footprint as a clinical-grade MDMA supplier into European research.
Incannex Healthcare Inc. (IXHL). Incannex Healthcare, whose psychedelic program PSX-001 is an oral synthetic psilocybin in Phase 2 for generalized anxiety disorder, announced a 1-for-30 reverse stock split effective February 26 to regain Nasdaq minimum-price compliance. The split reduced shares outstanding from roughly 358 million to about 12 million. The move reflected continued financing and listing pressure on small-cap psychedelic developers.
AtaiBeckley Inc. (ATAI). At an investor event, AtaiBeckley said a successful FDA End-of-Phase 2 meeting cleared the way to begin two parallel Phase 3 trials of BPL-003 (intranasal mebufotenin/5-MeO-DMT) in treatment-resistant depression in the second quarter of 2026. The Breakthrough Therapy-designated candidate is supported by Phase 2b data showing rapid antidepressant effects and durable improvement, with higher response after an optional second dose. Confirmation of the pivotal path is a key de-risking milestone for AtaiBeckley's lead program.
Clearmind Medicine Inc. (CMND). Clearmind Medicine announced publication of an international patent application for a novel therapy targeting weight loss and fatty-liver disease, extending the intellectual-property estate around its psychedelic-derived MEAI platform beyond alcohol use disorder. The filing broadens Clearmind's potential addressable indications. IP expansion is a recurring value driver for small psychedelic-adjacent biotechs seeking partnering optionality.
SciSparc Ltd. (SPRC). SciSparc said NeuroThera Labs, a roughly 75%-owned subsidiary, filed a patent application in Hong Kong under its collaboration with Clearmind Medicine covering a combination treatment for major depressive disorder. The candidate pairs Clearmind's proprietary MEAI (5-methoxy-2-aminoindane) with NeuroThera's palmitoylethanolamide (PEA). The filing extends an ongoing IP-building effort between the two microcap developers around non-classic psychedelic compounds.
Numinus Wellness Inc. (NUMI). Numinus said the Toronto Stock Exchange's continued listing committee decided to delist its shares, effective April 22, 2026, and that the company has applied to list on the Canadian Securities Exchange instead. The update followed a broader restructuring in which Numinus sold its U.S. wellness clinics and narrowed its focus to a clinical trial site network and practitioner training platform. Management said it continues to evaluate financings, partnerships and potential M&A to shore up its balance sheet.
Transcend Therapeutics / Otsuka Pharmaceutical. Japan's Otsuka Pharmaceutical agreed to acquire privately held Transcend Therapeutics, paying $700 million at closing plus up to $525 million in sales-based milestones, for total potential consideration of about $1.225 billion. Transcend's lead asset is TSND-201 (methylone), a rapid-acting neuroplastogen with FDA Breakthrough Therapy designation being developed for PTSD, with Phase 2 data published in JAMA Psychiatry in February 2026. The deal, expected to close in Q2 2026, is one of the largest strategic acquisitions in the psychedelic-adjacent space and signals big-pharma appetite for the sector.
What to Watch
With two positive Phase 3 psilocybin trials in hand and a rolling NDA underway, the central 2026 question shifts from 'will the data work?' to 'how fast can approval and access follow?' Watch for AtaiBeckley's BPL-003 Phase 3 start, Definium's first Phase 3 lysergide readout in mid-year, and whether the federal policy conversation — Right to Try expansion, VA centers of excellence — converts into concrete access pathways.
This report is compiled by Psychedelic Invest from primary company disclosures and industry reporting; each story links its source. It is provided for informational purposes only and is not investment advice.