Atai Life Sciences' BPL-003 showed robust, rapid, and durable antidepressant effects in Phase 2b TRD data, spiking shares over 20%. BPL-003's short clinic time and strong efficacy could fit existing treatment paradigms, potentially rivaling J&J's Spravato if regulatory hurdles are cleared. Regulatory approval remains uncertain due to controlled substance scheduling, but Atai's differentiated pipeline and patent position offer significant long-term upside.

Atai Life Sciences (NASDAQ:ATAI, ETR:9VC) announced positive topline results from its Phase 2b clinical study in patients with treatment-resistant depression, and a private placement for gross proceeds of $50 million. The clincial study, in partnership with Beckley Psytech, is evaluating BPL-003, a formulation of the psychedelic compound mebufotenin, also known as DMT, that is administered using a nasal spray.

Atai Life Sciences ATAI and Beckley Psytech Limited jointly announced topline results from the eight-week, quadruple-masked, dose-finding core stage of the Phase 2b trial of a single dose of BPL-003 (intranasal mebufotenin (5-MeO-DMT) benzoate) in patients with treatment-resistant depression (TRD).

Financing co-led by Ferring Ventures S.A. and Apeiron Investment Ltd. with participation from new and existing healthcare-focused institutional investors, including Ally Bridge Group and ADAR1 Financing co-led by Ferring Ventures S.A. and Apeiron Investment Ltd. with participation from new and existing healthcare-focused institutional investors, including Ally Bridge Group and ADAR1

NEW YORK, and AMSTERDAM and OXFORD, United Kingdom, July 01, 2025 (GLOBE NEWSWIRE) --  atai Life Sciences (NASDAQ: ATAI) (“atai”), a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes, and Beckley Psytech Limited (“Beckley Psytech”), a private clinical-stage biopharmaceutical company pioneering the next generation of mental health treatments, today jointly announced positive topline results from the eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial evaluating the efficacy and safety of a single dose of BPL-003 (intranasal mebufotenin (5-MeO-DMT) benzoate) in patients with treatment-resistant depression (TRD). The study achieved its primary endpoint as well as all key secondary endpoints. At Day 29, a single 12 mg dose of BPL-003 demonstrated a statistically significant reduction in depressive symptoms, as measured by the Montgomery-Åsberg Depression Rating Scale (MADRS), with a mean decrease of 11.1 points from baseline compared to a 5.8 point reduction in the 0.3 mg comparator group (p = 0.0038). For the key secondary efficacy endpoints, a single 8 mg dose of BPL-003 also showed significant improvement at Day 29, with a mean MADRS score reduction of 12.1 points (p=0.0025 for change vs. 0.3 mg control). Notably, both the 8mg and 12mg doses of BPL-003 showed statistically significant improvements in MADRS scores as early as one day after dosing, with effects generally maintained out to Week 8.

Here is how atai Life Sciences N.V. (ATAI) and Idexx Laboratories (IDXX) have performed compared to their sector so far this year.

The psychedelics sector is experiencing a resurgence of optimism in 2025 driven by a more favorable federal government under President Donald Trump's administration, shifting state-level policies, and encouraging clinical trial results supporting the efficacy of psychedelic therapies. A major setback for the sector was the Food and Drug Administration rejecting Lykos Therapeutics' MDMA-assisted therapy for post-traumatic stress disorder in August last year.

NEW YORK, June 15, 2025 (GLOBE NEWSWIRE) -- Class Action Attorney Juan Monteverde with Monteverde & Associates PC (the “M&A Class Action Firm”), has recovered millions of dollars for shareholders and is recognized as a Top 50 Firm in the 2024 ISS Securities Class Action Services Report. The firm is headquartered at the Empire State Building in New York City and is investigating Atai Life Sciences N.V. (NASDAQ:  ATAI ) related to the acquisition of Beckley Psytech Limited. Is it a fair deal?

Does atai Life Sciences N.V. (ATAI) have what it takes to be a top stock pick for momentum investors?

Here is how atai Life Sciences N.V. (ATAI) and Novartis (NVS) have performed compared to their sector so far this year.