AtaiBeckley’s BPL-003 Shows Rapid, Durable Antidepressant Response in Treatment-Resistant Depression Patients on SSRIs; Phase 2a Data Published in CNS Drugs
Rhea-AI Summary
AtaiBeckley (NASDAQ: ATAI) reported peer‑reviewed Phase 2a results showing a single intranasal dose of BPL‑003 produced a 66.7% antidepressant response rate by Day 2 in SSRI‑concomitant TRD patients (n=12) and durable responses at Day 85: 83% (10 mg) and 66.7% (12 mg).
FDA Breakthrough Therapy designation granted Oct 2025; Phase 3 initiation is on track for Q2 2026 following FDA End‑of‑Phase 2 alignment.
Positive
- Day‑2 responder rate of 66.7% (≥50% MADRS reduction)
- Durability to Day‑85: 83% responders (10 mg) and 66.7% (12 mg)
- FDA Breakthrough Therapy designation granted October 2025
- Phase 3 on track to start in Q2 2026 after EOP2 alignment
- Rapid clinical effect with mean discharge ~100 minutes post‑dose
- No serious adverse events reported in the study cohort
Negative
- Small sample size: Part 2 cohort n=12 limits statistical power
- Open‑label, single‑center design increases potential bias and limits generalizability
- Dose durability discrepancy: 10 mg cohort showed higher Day‑85 response than 12 mg
News Market Reaction – ATAI
On the day this news was published, ATAI declined 0.79%, reflecting a mild negative market reaction. Argus tracked a peak move of +2.2% during that session. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $11M from the company's valuation, bringing the market cap to $1.38B at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Momentum scanner flagged only RAPP in this window, moving -3.02% while ATAI was flagged as moving up. Broader peer list shows mixed moves, suggesting today’s setup is stock-specific rather than a coordinated biotech move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 24 | Index inclusion | Positive | -0.3% | Added to major S&P and CRSP indices with large passive AUM exposure. |
| Mar 17 | Clinical data | Positive | +0.0% | Phase 2a BPL-003 monotherapy data showed rapid, durable MADRS reduction. |
| Mar 10 | Pipeline update | Positive | +6.4% | Confirmed BPL-003 Phase 3 start in Q2 2026 after successful FDA EOP2. |
| Mar 06 | Earnings update | Neutral | -4.2% | Reported FY25 results, cash of $220.7M and runway into early 2029. |
| Mar 03 | Regulatory meeting | Positive | +0.3% | Announced successful FDA End-of-Phase 2 meeting for BPL-003 in TRD. |
Recent ATAI news has often seen muted or negative reactions even to positive clinical and index‑inclusion catalysts, with only the End‑of‑Phase 2 update showing a clearly strong upside response.
Over the past month, AtaiBeckley has repeatedly highlighted BPL‑003’s progress. A March 3 End‑of‑Phase 2 update and the March 10 Phase 3 program confirmation underscored FDA support and timing for dual pivotal studies. Subsequent March 17 and March 24 communications reinforced rapid, durable antidepressant effects and inclusion in major indices, yet price reactions were flat to slightly negative. This new Phase 2a SSRI-concomitant dataset extends the same BPL‑003 narrative of rapid, durable response as Phase 3 approaches in Q2 2026.
Regulatory & Risk Context
The company has an effective S-3ASR shelf filed on September 29, 2025, used for registering securities for resale. The filing is effective, with at least 3 prospectus supplements (424B) already filed, indicating the shelf has been tapped multiple times. No aggregate capacity amount is specified in the provided summary.
Market Pulse Summary
This announcement highlights peer-reviewed Phase 2a data showing a 66.7% Day‑2 response rate and durable antidepressant benefit for BPL‑003 in TRD patients continuing SSRI therapy, with discharge readiness at about 100 minutes and no serious adverse events. It extends prior monotherapy evidence and supports planned Phase 3 initiation in Q2 2026. Investors may track upcoming Part 4 adjunctive data, overall BPL‑003 Phase 3 design, and future financing or regulatory steps around commercialization plans.
Key Terms
breakthrough therapy designation regulatory
end-of-phase 2 regulatory
madrs medical
5-ht1a medical
5-ht2a medical
ssri medical
open-label medical
phase 3 medical
AI-generated analysis. Not financial advice.
66.7% of participants achieved an antidepressant response by Day 2 following a single intranasal dose of BPL-003 in both the 10 mg (n=6) and 12 mg (n=6) cohorts- Durable responses observed at Day 85:
83% (5/6) (10 mg) and66.7% (4/6) (12 mg) - BPL-003 received FDA Breakthrough Therapy Designation in October 2025
- Phase 3 initiation on track for Q2 2026
NEW YORK, April 08, 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 peer-reviewed Phase 2a results (NCT05660642) in CNS Drugs demonstrating that a single intranasal dose of BPL-003 (mebufotenin benzoate), which holds FDA Breakthrough Therapy Designation, achieved rapid and sustained reductions in MADRS scores from baseline in participants with treatment-resistant depression (TRD) who remained on stable SSRI therapy throughout the study (n=12). A
| Clinical Data Summary | |
| Drug | BPL-003 (mebufotenin benzoate intranasal spray) |
| Mechanism | 5-HT1A and 5-HT2A agonist associated with rapid onset and treatment experience of ~2 hours |
| Indication | Treatment-resistant depression (TRD); failure to respond to ≥2 prior antidepressants at adequate dose and duration |
| Designations | U.S. FDA Breakthrough Therapy Designation granted October 2025 |
| Trial | NCT05660642: four-part Phase 2a open-label study. Part 2 (SSRI-concomitant, n=12) reported here; Part 1 (monotherapy, single dose, n=12) published in Journal of Psychopharmacology in March 2026. Part 3 (8 mg + 12 mg, monotherapy, n = 12) topline announced September 2025. Part 4 (8 mg + 8 mg, adjunctive) ongoing; initial data expected Q4 2026. |
| Endpoint | Safety and tolerability; exploratory Montgomery-Asberg Depression Rating Scale (MADRS) total score change from baseline |
| Responder Rate (Day 2) | |
| Durability (Day 85) | |
| MADRS‑6 Core Symptoms | 19.2 → 6.2 (10 mg); 21.0 → 9.3 (12 mg); ≤10 = remission |
| Safety | No serious adverse events; majority of drug‑related AEs transient and resolved on same day |
| Discharge Readiness | Mean ~100 minutes post‑dose |
| Phase 3 Status | End-of-Phase 2 meeting with U.S. FDA completed; Phase 3 initiation on track for Q2 2026 |
Management Commentary
Srinivas Rao, Co-Founder and Chief Executive Officer of AtaiBeckley said: "A
Dr. Kevin Craig, Chief Medical Officer at AtaiBeckley, added: “This study provides the first Phase 2a evidence that BPL‑003 can be administered alongside SSRIs without compromising efficacy or safety, a meaningful advance given that many TRD patients remain on chronic SSRI therapy. The rapid resolution of acute effects and ~100‑minute discharge readiness further support the feasibility of integrating BPL‑003 into existing interventional psychiatry settings.”
Study Details
The 12-week, open-label, single-center, ascending-dose trial enrolled 12 adults aged 18 to 75 years with moderate-to-severe major depressive disorder (baseline MADRS ≥24) and TRD. All participants had failed at least two prior antidepressants and remained on a stable dose of one of four SSRIs - citalopram, escitalopram, sertraline or fluoxetine - throughout the study. Six participants received a single intranasal 10 mg dose of BPL-003 and six received a single intranasal 12 mg dose of BPL-003, with psychological support before, during and after dosing. Participants were followed for 12 weeks.
This publication represents Part 2 of the four-part Phase 2a open-label study. Data from Part 1 (BPL-003 monotherapy, 10 mg single dose, n=12) was published in the Journal of Psychopharmacology in March 2026, reporting a mean 12.6-point MADRS reduction by Day 2, sustained through 12 weeks. Topline data from Part 3 (8 mg + 12 mg, BPL-003 monotherapy, n=12) were announced in September 2025, showing that a second dose of BPL-003 at Week 2 has the potential to induce additional reductions in MADRS scores without impact on the safety and tolerability profile of the treatment. Part 4 of the program - evaluating a two-dose induction regimen of BPL-003 (8 mg + 8 mg) in participants with TRD who are also receiving defined antidepressants – is ongoing. Initial data from that cohort is expected in Q4 2026.
About BPL-003
BPL-003 is a patent-protected, proprietary intranasal formulation of mebufotenin benzoate (5-MeO-DMT), 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 psychedelic duration, and is being investigated as a potential therapy for treatment-resistant depression (TRD) and 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
Treatment-resistant depression affects an estimated
About AtaiBeckley Inc.
AtaiBeckley is a clinical-stage biotechnology company on a mission to transform patient outcomes by developing rapid-acting, durable and convenient mental health treatments. AtaiBeckley’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (DMT buccal film) for TRD and EMP-01 ((R)-MDMA HCI) for social anxiety disorder. BPL-003 is in Phase 3 planning, VLS-01 and EMP-01 are in Phase 2 clinical development. The Company is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create breakthroughs in mental health through transformative interventional psychiatry therapies that can integrate seamlessly into healthcare systems.
For the latest updates and to learn more about the AtaiBeckley mission, visit www.ataibeckley.com or follow the Company on LinkedIn and on X.
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 of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “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: our business strategy and plans; expectations regarding the outcome of regulatory discussions regarding the development of BPL-003; expectations regarding the advancement into Phase 3 studies in adults with TRD and related milestones; expectations regarding the design of the Phase 3 program; 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, the 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”), as such factors may be updated from time to time in our quarterly reports and other filings with the SEC. AtaiBeckley disclaims any obligation to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.
Contact Information:
Investors:
Jason Awe, PhD
VP, Investor Relations
IR@ataibeckley.com
Media:
Charlotte Chorley
Associate Director, Communications
PR@ataibeckley.com
