AtaiBeckley Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business and Clinical Update Phase 3 pivotal program initiation for BPL-003 in treatment-resistant depression remains on track for Q2 2026 following successful End‑of‑Phase 2 meeting with the U.S. Food and Drug AdministrationO...

$ATAI surges on Q4 2025 earnings beat, BPL-003 on track for Phase 3 in Q2 2026 for treatment-resistant depression
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Atai Life Sciences and Beckley Psytech have received FDA Breakthrough Therapy designation for their nasal spray BPL-003 (mebufotenin benzoate), targeting treatment-resistant depression in adults

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atai Life Sciences shares rose nearly 15% on Tuesday after mid-stage trial results showed that its two-dose nasal spray treatment, BPL-003, led to rapid, significant, and long-lasting improvements in depression symptoms, with benefits lasting up to three months.

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Psychedelic drug stocks surged after Bloomberg News reported AbbVie is in talks to acquire Gilgamesh Pharmaceuticals in a ~$1B deal.

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Atai Life Sciences shares dropped over 15% in after-hours trading after its portfolio company Recognify Life Sciences reported that its schizophrenia drug inidascamine failed to meet the primary endpoint in a Phase 2b trial.

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Atai Life Sciences shares rose after its psychedelic drug BPL-003, developed with Beckley Psytech, showed statistically significant reductions in depressive symptoms in a mid-stage trial for treatment-resistant depression (TRD).

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Compass Pathways shares fell ~46% on Monday after releasing Phase 3 data for its psilocybin-based treatment (COMP360) targeting treatment-resistant depression, which met its primary endpoint but disappointed investors expecting stronger efficacy.

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