AtaiBeckley Inc

ATAI

Market cap $1.34B

The FDA has supported the Phase 3 design for BPL-003, an intranasal psychedelic-derived therapy for treatment-resistant depression AtaiBeckley NV (NASDAQ:ATAI, XETRA:9VC), a clinical-stage biotechnology company focused on mental health treatments, has received backing from US regulators to advance its BPL-003 drug candidate into Phase 3 clinical trials for treatment-resistant depression, a condition affecting millions of patients for whom standard antidepressants have failed. The company said a formal end-of-phase 2 meeting with the Food and Drug Administration (FDA) concluded successfully, with the regulator indicating support for its proposed pivotal trial programme and providing constructive feedback on study design, safety database requirements and other key components.

AtaiBeckley Inc. (ATAI) Discusses Positive Topline Results From Exploratory Phase IIa Study of EMP-01 in Social Anxiety Disorder Transcript

AtaiBeckley NV (NASDAQ:ATAI, XETRA:9VC) has reported positive topline results from an exploratory Phase 2a trial evaluating its oral R-MDMA candidate, EMP-01, in adults with social anxiety disorder (SAD), with the study meeting its primary safety objective and showing encouraging efficacy signals. The clinical-stage biotechnology company said the randomized, double-blind, placebo-controlled study enrolled 71 adults with moderate-to-severe SAD across seven sites in the United Kingdom.

AtaiBeckley Inc. (NASDAQ: ATAI) on Thursday shared topline results from an exploratory Phase 2a trial of EMP-01, an oral R-MDMA treatment for Social Anxiety Disorder.

EMP-01 met its primary objective on safety and tolerability, demonstrating a generally favorable and manageable safety and tolerability profile EMP-01 demonstrated a clinically meaningful placebo-adjusted least squares mean reduction of 11.85 points on the Liebowitz Social Anxiety Scale (LSAS) at Day 43 (Hedges' g = 0.45; p-value = 0.036, one-tailed) EMP-01 demonstrated a robust separation from placebo on the Clinician Global Impression–Improvement (CGI-I) assessment: 49% responders vs. 15% for placebo, corresponding to a Number Needed to Treat (NNT) of 2.95 EMP-01 demonstrated improvements across both Fear and Avoidance sub-domains of the LSAS, including improvement in social avoidance behaviors after two administrations over six weeks, and without adjunctive psychotherapy More detailed analyses of the data will be described in upcoming scientific venues and will guide subsequent development Conference call scheduled for 8:00 a.m.

NEW YORK, Feb. 20, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc. (NASDAQ: ATAI) (“AtaiBeckley” or “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments, today announced that it will host a Virtual Investor Day on Friday, March 6, 2026, from 9:00 a.m. to 12:00 p.m.

AtaiBeckley NV (NASDAQ:ATAI, XETRA:9VC) announced that it has appointed Michael Faerm as chief financial officer, effective March 9, 2026, as the clinical-stage biotechnology company continues to advance its mental health treatment pipeline. According to the company, Faerm brings more than 25 years of experience spanning life sciences firms, equity research and investment banking.

Jefferies analysts said the continued commercial momentum of Johnson & Johnson (NYSE:JNJ)'s Spravato (esketamine nasal spray) could provide a meaningful tailwind for the broader psychedelics sector, with AtaiBeckley NV (NASDAQ:ATAI, XETRA:9VC) a direct beneficiary. As reported by J&J on Wednesday, Spravato's fourth quarter 2025 sales in treatment-resistant depression (TRD) rose 10% sequentially to $503 million worldwide.

Last year, the biotechnology industry leaned heavily into the power of artificial intelligence (AI), using machine learning models to identify drug targets, to optimize molecules, and to make key predictions about trial outcomes. Alongside the continued proliferation of technology within the drug development space, companies with a focus on obesity, rare diseases, and oncology applications saw commercial achievements.

AtaiBeckley NV (NASDAQ:ATAI, XETRA:9VC) announced that it participated in the 64th Annual Meeting of the American College of Neuropsychopharmacology (ACNP), held January 12 to 15, 2026, in Nassau, The Bahamas, where the company presented two scientific posters and delivered a Hot Topic Presentation. The clinical-stage biotechnology company said the presentations included new clinical and preclinical data related to its mental health development programs.