Monitor for topline Phase 2b data in Q4 2026, which will be the key catalyst for VLS-01. The strategic expansion into MDD and GAD signals broader pipeline optionality but depends on Phase 2 results.
Price Chart
Executive Summary
AtaiBeckley announced completion of enrollment (156 patients) in the Phase 2b Elumina trial of VLS-01 for treatment-resistant depression, with topline data expected in Q4 2026. The company also outlined plans to advance VLS-01 into Phase 3 for major depressive disorder and potentially generalized anxiety disorder, subject to supportive Phase 2 results. No financial results or efficacy data were reported in this filing.
Key Facts
- 156 patients randomized in multi-center, double-blind, placebo-controlled Phase 2b Elumina trial of VLS-01 for treatment-resistant depression
- Topline data anticipated in Q4 2026
- Company intends to advance VLS-01 into Phase 3 for major depressive disorder, with generalized anxiety disorder as a potential follow-on indication
- BPL-003 is concurrently advancing through Phase 3 for treatment-resistant depression with Breakthrough Therapy Designation
Financial Impact
No financial data reported; clinical milestone only.
Risk Factors
- Phase 2b data may not meet primary endpoint
- Regulatory alignment for MDD program uncertain
- Cash burn for clinical development without near-term revenue
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3322260 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 11, 2026 21d ago | 25-NSE | $7.30 awaiting T+20 | awaiting T+20 | — | — |
Aug 10, 2026 7w ago | DEFM14A | $7.25 $7.28 | ▲ +0.41% | ▲ +1.33% | — |
Aug 9, 2026 7w ago | Institutional Cluster | $7.25 $7.28 | ▲ +0.41% | ▲ +1.33% | — |
Jul 16, 2026 11w ago | DEFA14A / 8-K | $7.15 $7.25 | ▲ +1.40% | ▼ −2.22% | — |
Jul 7, 2026 12w ago | 144 | $5.17 $7.22 | ▲ +39.65% | ▲ +36.38% | — |
Jul 6, 2026 12w ago | Press Release | $4.96 $7.18 | ▲ +44.76% | ▲ +45.32% | — |
Jun 26, 2026 14w ago | 144 | $5.36 $7.18 | ▲ +33.96% | ▲ +34.23% | — |
Jun 25, 2026 14w ago | 144 | $5.29 $7.17 | ▲ +35.54% | ▲ +34.28% | — |
Jun 3, 2026 17w ago | 8-K | $4.53 $5.19 | ▲ +14.57% | ▲ +15.57% | — |
May 12, 2026 20w ago | Press Release | $4.15 $3.78 | ▼ −8.92% | ▼ −7.19% | — |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Try SecBot Free Coming soon: SecBot Pro with alerts, watchlists, and API access