Months-long timeline to topline data readout; stock will likely trade on broader sentiment around the MDD program and ongoing TONMYA commercial ramp rather than near-term catalysts. Watch for interim enrollment updates or early stopping rules, but no binary event expected until primary completion.
Price Chart
Executive Summary
Tonix Pharmaceuticals announced first patient enrollment in the HORIZON Phase 2 study of TNX-102 SL (5.6 mg) as a first-line monotherapy for major depressive disorder. The potentially pivotal, 360-patient, randomized, double-blind, placebo-controlled trial has a 6-week primary endpoint (MADRS total score change from baseline). TNX-102 SL is already FDA-approved (TONMYA) for fibromyalgia, but this is an early-stage read on a new indication with no financial data or guidance provided.
Key Facts
- First patient enrolled in HORIZON Phase 2 study of TNX-102 SL 5.6 mg for MDD
- Study is potentially pivotal, randomized, double-blind, placebo-controlled, targeting ~360 patients at ~30 US sites
- Primary endpoint: change from baseline in MADRS total score at Week 6; secondary endpoints include sleep quality and anxiety measures
- TNX-102 SL (TONMYA) was FDA-approved for fibromyalgia in August 2025 and is commercially launched
- No financial results, revenue, or guidance were disclosed in the filing
Financial Impact
No financial data reported; this is a clinical milestone only.
Risk Factors
- Phase 2 clinical failure risk: MDD is a competitive space with high placebo response rates
- No guarantee that Phase 2 results will be positive or support a pivotal Phase 3 program
- Trial enrollment delays or data readout timeline extension could create uncertainty
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 3 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001493152-26-030408 |
| Document: 0001493152-26-030408-index.html | 0001493152-26-030408 |
| Document: 0001493152-26-030408.txt | 0001493152-26-030408 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 19, 2026 7d ago | Press Release | $5.73 | awaiting T+20 | — | $5.30 (−7.50%) |
Oct 15, 2026 11d ago | 8-K | $6.42 | awaiting T+20 | — | $5.30 (−17.45%) |
Oct 2, 2026 24d ago | 8-K | $8.07 | awaiting T+20 | — | $5.30 (+34.32%) |
Sep 22, 2026 4w ago | 8-K | $10.59 $5.78 | ▼ −45.42% | ▼ −44.86% | $5.30 (−49.95%) |
Sep 8, 2026 6w ago | 8-K | $13.16 $7.70 | ▼ −41.49% | ▼ −43.46% | $5.30 (−59.73%) |
Aug 10, 2026 11w ago | 8-K | $12.59 $13.16 | ▲ +4.53% | ▲ +5.44% | $5.30 (−57.90%) |
Aug 10, 2026 11w ago | Press Release | $12.59 $13.16 | ▲ +4.53% | ▲ +5.44% | $5.30 (−57.90%) |
Aug 3, 2026 12w ago | 8-K | $10.67 $14.10 | ▲ +32.15% | ▲ +30.91% | $5.30 (−50.33%) |
Jul 27, 2026 13w ago | Press Release | $10.37 $12.45 | ▲ +20.06% | ▲ +16.76% | $5.30 (−48.89%) |
Jul 13, 2026 15w ago | 8-K | $11.71 $12.59 | ▲ +7.56% | ▲ +4.38% | $5.30 (−54.72%) |
US Market Status
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