atai Life Sciences and Beckley Psytech Announce U.S. FDA Breakthrough Therapy Designation Granted to BPL-003, Underscoring its Potential in Treatment-Resistant Depression
atai Life Sciences (NASDAQ: ATAI) and Beckley Psytech announced that the U.S. FDA has granted Breakthrough Therapy designation to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression (TRD).
Designation follows positive Phase 2b topline results where a single 8 mg or 12 mg dose produced clinically meaningful, statistically significant symptom reductions within 24 hours with effects sustained through an 8-week trial; most patients were ready for discharge by 90 minutes post-dose. The companies state Phase 3 trials are expected to begin in Q2 2026, subject to FDA alignment.
atai Life Sciences (NASDAQ: ATAI) e Beckley Psytech hanno annunciato che la FDA statunitense ha concesso designazione di Breakthrough Therapy a BPL-003 (benzoato di mebufotenina) spray nasale per adulti con depressione resistente al trattamento (TRD).
La designazione segue dati positivi di fase 2b topline in cui una singola dose da 8 mg o 12 mg ha prodotto riduzioni dei sintomi clinicamente significative e statisticamente significative entro 24 ore, con effetti mantenuti durante un trial di 8 settimane; la maggior parte dei pazienti era pronta per la dimissione entro 90 minuti dalla somministrazione. Le aziende affermano che i trial di fase 3 dovrebbero iniziare nel Q2 2026, soggetti all’allineamento con la FDA.
atai Life Sciences (NASDAQ: ATAI) y Beckley Psytech anunciaron que la FDA de EE. UU. ha concedido designación de Terapia Innovadora a BPL-003 (benzoato de mebufotenina) en spray nasal para adultos con depresión resistente al tratamiento (TRD).
La designación sigue datos positivos de la fase 2b topline donde una única dosis de 8 mg o 12 mg produjo reducciones de síntomas clínicamente significativas y estadísticamente significativas dentro de 24 horas, con efectos sostenidos a lo largo de un ensayo de 8 semanas; la mayoría de los pacientes estuvieron listos para el alta a los 90 minutos posteriores a la dosis. Las compañías indican que se esperan ensayos de fase 3 para iniciar en Q2 2026, sujeto a la aprobación de la FDA.
atai Life Sciences (나스닥: ATAI)와 Beckley Psytech은 미국 식품의약국(FDA)이 BPL-003(메부페토닌 벤조에이트) 비강 스프레이를 치료저항성 우울증(TRD) 성인 환자에게 획기적 치료제로 지정했다는 소식을 발표했다.
이 지정은 2b 상위 결과를 따른 것으로, 8 mg 또는 12 mg의 단일 용량이 24시간 이내에 임상적으로 의미 있고 통계적으로 유의미한 증상 감소를 보였고, 8주 임상에서 효과가 지속되었으며, 투여 후 대부분의 환자들이 90분 이내에 퇴원 준비가 되었다.
양사는 FDA와의 조정에 따라 2026년 2분기(Q2 2026)에 3상 시험이 시작될 것으로 예상된다고 밝혔다.
atai Life Sciences (NASDAQ: ATAI) et Beckley Psytech ont annoncé que la FDA américaine a accordé la désignation de thérapeutique révolutionnaire à BPL-003 (benzoate de mébuténine) spray nasal pour les adultes atteints de dépression résistante au traitement (TRD).
Cette désignation fait suite à des résultats positifs de la phase 2b en topline où une seule dose de 8 mg ou de 12 mg a produit des réductions des symptômes cliniquement significatives et statistiquement significatives dans les 24 heures, avec des effets maintenus sur un essai de 8 semaines; la plupart des patients étaient prêts à être désinscrits après 90 minutes post-dose. Les entreprises indiquent que les essais de phase 3 devraient commencer au Q2 2026, sous réserve d’un alignement avec la FDA.
atai Life Sciences (NASDAQ: ATAI) und Beckley Psytech gaben bekannt, dass die US-amerikanische FDA die Breakthrough Therapy Designation für BPL-003 (Mebufenon-Benzat) Nasenspray für erwachsene Patienten mit therapieresistenter Depression (TRD) gewährt hat.
Die designierte Bezeichnung folgt positiven Phase-2b-Topline-Ergebnissen, bei denen eine einzelne Dosis von 8 mg oder 12 mg klinisch bedeutsame, statistisch signifikante Symptomenreduktionen innerhalb von 24 Stunden zeigte, mit Effekten, die sich in einem 8-Wochen–Verlauf hielten; die meisten Patienten waren 90 Minuten nach der Dosierung bereit zur Entlassung. Die Unternehmen geben an, dass Phase-3-Studien voraussichtlich im Q2 2026 beginnen werden, vorbehaltlich der Abstimmung mit der FDA.
atai Life Sciences (بورصة ناسداك: ATAI) وBeckley Psytech أعلنوا أن إدارة الغذاء والدواء الأمريكية (FDA) منحت تصنيف العلاج الرائد Breakthrough Therapy لـ BPL-003 (بنزونات الميبوفوتينين) كعلاج رذاذ أنفي للبالغين المصابين بالاكتئاب المقاوم للعلاج (TRD).
يأتي التصنيف عقب نتائج إيجابية من المرحلة 2b topline حيث أظهرت جرعة واحدة من 8 mg أو 12 mg انخفاضات سريرية ذات دلالة إحصائية في الأعراض خلال 24 ساعة مع استمرار التأثيرات طوال تجربة 8 أسابيع؛ وكانت معظم المرضى جاهزين للخروج خلال 90 دقيقة من بعد الجرعة. وتذكر الشركتان أن التجارب في المرحلة 3 من المتوقع أن تبدأ في الربع الثاني من 2026، رهناً بالتنسيق مع FDA.
atai Life Sciences (纳斯达克：ATAI) 与 Beckley Psytech 宣布，美国食品药品监督管理局（FDA）已授予 BPL-003（mebufotenin benzoate）鼻喷剂的突破性治疗资格，适用于治疗耐药性抑郁症（TRD）的成人患者。
该指定源于阶段 2b topline 的积极结果，其中单次 8 mg 或 12 mg剂量在 24 小时内产生临床上具有意义且统计学显著的症状缓解，且在一个 8 周的试验中效果持续；大多数患者在给药后 90 分钟就可以出院。公司表示，阶段 3 期试验预计将在 2026 年第二季度开始，前提是与 FDA 的协调一致。
- FDA Breakthrough Therapy designation for BPL-003
- Phase 2b: single 8 mg or 12 mg dose showed symptom reductions within 24 hours
- Antidepressant effects sustained through an 8-week trial
- Phase 3 initiation timing is subject to FDA alignment (Q2 2026 target)
- Breakthrough designation does not guarantee approval or commercial availability
Insights
FDA Breakthrough Therapy for BPL-003 accelerates pivotal planning and signals strong Phase 2b signal for treatment‑resistant depression.
BPL-003 received Breakthrough Therapy designation on
The designation provides structured FDA guidance and could shorten development and review time, but progress depends strictly on alignment with the agency and successful Phase 3 execution. Key dependencies include final Phase 2b data details, safety/tolerability across larger cohorts, and a pivotal protocol agreed with the FDA; the announcement notes Phase 3 initiation is expected in
Watch for finalized Phase 2b full dataset releases, the agreed Phase 3 protocol and endpoints, and any FDA meeting minutes or formal feedback ahead of the planned
- Breakthrough Therapy designation recognizes the potential of BPL-003 to deliver substantial improvement over existing therapies for patients with treatment-resistant depression
- FDA designation follows previously announced Phase 2b topline data which showed rapid and durable antidepressant outcomes following a single dose of BPL-003
- Breakthrough Therapy designation provides intensive FDA guidance to support advancement of BPL-003
NEW YORK and AMSTERDAM, Oct. 16, 2025 (GLOBE NEWSWIRE) -- atai Life Sciences (NASDAQ: ATAI) (“atai” or “Company”), and Beckley Psytech Limited (“Beckley Psytech”), who previously announced a planned strategic combination to create a global leader in transformative mental health therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) to BPL-003 (mebufotenin benzoate) nasal spray for adult patients with treatment-resistant depression (TRD).
BTD is granted to expedite development of drugs targeting serious or life-threatening conditions where preliminary clinical evidence suggests that the drug may demonstrate substantial improvement on one or more clinically significant endpoints over existing therapies. The designation facilitates collaboration with the FDA and has the potential to expedite development timelines and regulatory reviews. BPL-003 is designed to deliver rapid and durable antidepressant effects from a single dose with a short therapeutic experience. The designation follows positive topline results from Beckley Psytech’s Phase 2b core, blinded study of BPL-003 in TRD which showed that a single administration of 8 mg or 12 mg of BPL-003 led to clinically meaningful and statistically significant reductions in depressive symptoms within 24 hours, with effects sustained through the eight-week trial period. Notably, the majority of patients were deemed ready for discharge at the 90-minute post-dose assessment, underscoring the potential scalability of the BPL-003 treatment model and its potential to fit into the established two-hour, in-clinic interventional psychiatry treatment paradigm.
Cosmo Feilding Mellen, Chief Executive Officer and Co-Founder of Beckley Psytech, said, “Receiving Breakthrough Therapy designation is a significant milestone which highlights the potential of BPL-003 to address the urgent unmet need of patients whose depression is not helped by existing therapies. We believe the Breakthrough Therapy designation supports the strength of our clinical data and, importantly, it will help to ensure the pivotal Phase 3 clinical program will be as expedited and efficient as possible, guided by the FDA.”
Srinivas Rao, M.D., Ph.D., Chief Executive Officer and Co-Founder of atai Life Sciences, said, “We are now among a select group of mental health companies with clinical programs that have been recognized by the FDA with Breakthrough Therapy designations. BPL-003 is well-positioned for Phase 3 trials which are expected to initiate in the second quarter of 2026, subject to alignment with the FDA. This is great news for patients.”
About BPL-003
BPL-003 is Beckley Psytech’s novel, patent-protected, proprietary intranasal formulation of mebufotenin (5-MeO-DMT) benzoate, administered via a nasal spray device used in a previously approved drug product. BPL-003 is designed to deliver rapid and durable effects from a single dose, with a short treatment window, and is being investigated as a potential therapy for treatment-resistant depression (TRD) and for alcohol use disorder (AUD). BPL-003 has been granted Breakthrough Therapy designation by the U.S. Food and Drug Administration and is covered by granted US, UK and European composition-of-matter patents, with multiple further claims pending in various jurisdictions.
About Treatment-Resistant Depression
Depression is a debilitating and life-changing condition affecting nearly 300 million people across the globe, with around 52 million people affected by the condition in Europe and the US combined. Treatment-resistant depression occurs when an individual does not respond to two or more courses of antidepressants and some studies show that it may affect up to
About atai Life Sciences
atai is a clinical-stage biopharmaceutical company on a mission to develop highly effective mental health treatments to transform patient outcomes. Its pipeline of psychedelic-based therapies includes BPL-003 (intranasal mebufotenin benzoate) for treatment-resistant depression (TRD), which is being advanced through a strategic investment and planned strategic combination with Beckley Psytech Limited; VLS-01 (buccal film DMT) also for TRD; and EMP-01 (oral R-MDMA) for social anxiety disorder. All three programs are in Phase 2 clinical development. atai is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for TRD and opioid use disorder. These programs aim to address the complex nature of mental health providing commercially scalable interventional psychiatry therapies that can integrate seamlessly into healthcare systems.
Forward-looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act, and Section 21E of the Exchange Act. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, expectations regarding the potential benefits of the Breakthrough Therapy Designation; progress on and results of Beckley Psytech’s BPL-003 trials, and the timing of development and regulatory review of BPL-003; and the potential benefits of BPL-003 for patients with TRD.
Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, (i) the contemplated acquisition of Beckley Psytech and related transactions (collectively, the “Proposed Transactions”) may not be completed in a timely manner or at all, including the risk that any required shareholder approvals are not obtained; (ii) the failure to realize the anticipated benefits of the Proposed Transactions; (iii) the possibility that any or all of the various conditions to the consummation of the Proposed Transactions may not be satisfied or waived; (iv) the occurrence of any event, change or other circumstance that could give rise to the termination of the share purchase agreement governing the Proposed Transactions; and (v) the effect of the announcement or pendency of the Proposed Transactions on atai’s ability to retain and hire key personnel, or its operating results and business generally and other important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) and our Proxy Statement on Schedule 14A (the “Proxy Statement”) that was filed with the SEC on September 24, 2025, in each case, as such factors may be updated from time to time in atai’s other filings with the SEC. Atai disclaims any obligation or undertaking to update or revise any forward-looking statements contained herein, other than to the extent required by applicable law.
Additional Information and Where to Find It
This press release is being made in in respect of the Proposed Transactions. This communication is not a substitute for the Proxy Statement or any other document which the Company has or may file with the SEC. INVESTORS ARE URGED TO READ IN THEIR ENTIRETY THE PROXY STATEMENT REGARDING THE PROPOSED TRANSACTIONS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC, AS WELL AS ANY AMENDMENTS OR SUPPLEMENTS TO THOSE DOCUMENTS, BECAUSE THEY CONTAIN IMPORTANT INFORMATION.
A free copy of the Proxy Statement, as well as other filings containing information about the Company, may be obtained at the SEC’s website (http://www.sec.gov).
Contact Information
Investor Contact:
IR@atai.com
Media Contact:
PR@atai.com
Beckley Psytech Media Contact:
charlotte.chorley@beckleypsytech.com
FAQ
What did ATAI and Beckley Psytech announce about BPL-003 on October 16, 2025?
What Phase 2b results supported the FDA Breakthrough designation for BPL-003 (ATAI)?
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How quickly did patients recover after BPL-003 dosing in the Phase 2b trial (ATAI)?
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