AtaiBeckley Completes VLS-01 Dosing in Phase IIb Depression Study
ATAI completes dosing in the phase IIb Elumina study of VLS-01 for treatment-resistant depression, with top-line efficacy and safety data due in fourth-quarter 2026.
AtaiBeckley completes dosing in Phase 2b depression trial, expects topline data in Q4
AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) said on Monday that it has completed dosing the final patient in its Phase 2b Elumina clinical trial evaluating investigational therapy VLS-01 for adults with treatment-resistant depression (TRD), with topline results expected in the fourth quarter of 2026. The randomized, double-blind, placebo-controlled trial enrolled 156 patients across multiple centers.
AtaiBeckley: BPL-003's Promising Potential On TRD Keeps Me Bullish
ATAI is now a more focused psychedelics biotech. Particularly, BPL-003 is their main bet on TRD's sizeable TAM. BPL-003 has aligned its research with the FDA's feedback and will proceed with a two-study Phase 3 trial. We'll see its topline readouts by early 2029. ATAI also has VLS-01, which gives it a nearer-term Q4 2026 TRD catalyst. EMP-01 adds some optionality in social anxiety disorders as well.
AtaiBeckley to join Russell 2000 and Russell 3000 indexes following annual reconstitution
AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) announced on Thursday that it will be added to the Russell 2000 Index and the Russell 3000 Index, effective at the open of US markets on June 29, as part of the 2026 Russell indexes reconstitution. The clinical-stage biotechnology company said the inclusion broadens its exposure to institutional investors and index-tracking funds.
AtaiBeckley nears key clinical catalysts, Jefferies stays positive with repeat ‘Buy' rating
AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) has kept Jefferies analysts bullish on the company following a fireside chat in New York City, with the firm reiterating a 'Buy' rating and a $10 price target on the company, implying roughly 120% upside from current levels. The firm's outlook centers on strengthening late-stage visibility across the company's psychedelic pipeline and what it described as an increasingly constructive regulatory backdrop.
AtaiBeckley launches mental health patient impact grant program
AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) has announced the launch of a new Patient Impact Grant Program aimed at supporting non-profit organizations working to improve mental health outcomes through community initiatives, education and research. The clinical-stage biotechnology company said the program will award three grants of $20,000 each to mission-driven organizations focused on advancing mental health support and patient outcomes.
AtaiBeckley clinical pipeline advances toward multiple late-stage data catalysts, Jefferies says
AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) is moving toward a series of late-stage clinical inflection points in its psychedelic drug pipeline, with multiple Phase III and Phase II readouts expected over the next several years that could help define the outlook for its $1B+ portfolio, according to Jefferies analysts. Following the company's Q1 results and corporate update, the firm highlighted multiple programs targeting treatment-resistant depression (TRD) and related psychiatric conditions, including BPL-003, VLS-01, and EMP-01, as key drivers of upcoming clinical and data readouts.
AtaiBeckley targets Q2 start for Phase 3 depression trial as pipeline advances
AtaiBeckley Inc. (NASDAQ:ATAI, XETRA:9VC) is preparing to launch its pivotal Phase 3 program for its lead treatment-resistant depression therapy in the second quarter of 2026, while projecting its cash reserves will support operations into 2029 as the company advances multiple mental health treatment candidates through clinical development. In a statement released alongside the company's first quarter earnings on Tuesday, AtaiBeckley said its Phase 3 ReConnection program for BPL-003, a mebufotenin benzoate nasal spray being developed for treatment-resistant depression (TRD), remains on track to begin in Q2 2026 following an End-of-Phase 2 meeting with the US Food and Drug Administration.
These 3 Psychedelic Stocks Activated After Trump's Executive Order
The Trump administration's April 2026 executive order in support of psychedelic drugs may have flown under the radar for many investors in the midst of the Iran war and numerous other high-profile domestic political news stories, but the implications for this small but growing industry are tremendous. Indeed, within days, the FDA began to make moves, awarding national priority vouchers to select companies developing drugs in this category, thereby reducing drug review times considerably.
This 4/20, Wall Street Is Betting on More Than Marijuana
While many investors focused on the annual 4/20 holiday, expecting the usual buzz around marijuana stocks, a quiet revolution was unfolding in Washington. Over a weekend when most of the market was logged off, the administration issued a bombshell executive order designed to fast-track psychedelic medicines to market.
How Trump's psychedelics executive order could unlock stalled cannabis reform
The White House psychedelics executive order accelerates research, clinical trials and "Right to Try" access for drugs like psilocybin, MDMA and ibogaine. The order does not change their legal status, but reinforces a federal move toward medical, evidence-based framework for other alternative medicines, like cannabis, experts say.
Psychedelics stocks rise after Trump order expands research, access pathways
Shares of psychedelics-related stocks climbed in early trade on Monday after US president Donald Trump signed an executive order aimed at accelerating research into psychedelic-assisted therapies and expanding patient access for certain serious mental health conditions, including post-traumatic stress disorder (PTSD) and treatment-resistant depression. The executive order, signed by Trump on Saturday, directs the US Food and Drug Administration (FDA) Commissioner to prioritize review pathways for psychedelic drugs that have received Breakthrough Therapy designation for serious mental illnesses and meet criteria under a national voucher program designed to speed regulatory review.
