AtaiBeckley NV (NASDAQ:ATAI, ETR:9VC) is gaining analyst attention after Phase 2b results for its investigational therapy BPL-003 demonstrated rapid, meaningful, and durable antidepressant effects in treatment-resistant depression (TRD), reinforcing its potential as a differentiated psychedelic therapy.
Jefferies highlighted that the data could influence dosing strategies and commercial positioning, given the single-dose durability and strong remission rates observed in the open-label extension (OLE).
“The Phase 2b TRD data have produced one of the most differentiated psychedelic datasets to date, namely its single-dose durability,” Jefferies wrote, noting that pooled 8mg and 12mg dosing in the OLE produced a 63% response rate and 48% remission, while a subset reached 67% remission.
The analysts added that these findings suggest re-dosing may only be required every two to three months, a potential advantage for patients and pricing.
“ATAI’s psychedelics can fit into the 2-hour, in-clinic treatment paradigm established by Spravato (intranasal esketamine) in TRD, which is at a $1.8 billion+ run rate and guided to reach $3 billion to 3.5 billion+ annually by 2027 to 2028,” they added. “Investor sentiment has improved with a friendlier administration.”
The broker also underscored the favorable safety profile and Breakthrough Therapy Designation from the FDA, positioning BPL-003 as a compelling alternative in the TRD market.
Looking ahead, Atai expects an FDA end-of-Phase 2 meeting in Q1 2026, followed by the initiation of two pivotal Phase 3 studies in Q2 2026 with the 8mg dose.
Additional Phase 2 readouts for oral R-MDMA in social anxiety disorder and buccal film DMT for TRD are anticipated later in 2026.
Jefferies has a ‘Buy’ rating on ATAI with a $10 price target, implying upside of 130% from the company’s share price on Tuesday afternoon. Shares of AtaiBeckley are up 225% so far in 2025.