Monitor for clinical trial progress and upcoming FDA submissions, as successful development of ONP-002 could position Oragenics in the growing concussion treatment market projected to reach $9 billion by 2030.
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Executive Summary
Oragenics announced the first patient dosing in its Phase IIa clinical trial for ONP-002, a potential treatment for concussion and mild traumatic brain injury. This milestone follows site activation in Australia and supports the company's plan to submit an IND application to the FDA in Q4 2026.
Key Facts
- First patient dosed in Phase IIa clinical trial for ONP-002 in Australia
- Trial evaluates treatment for concussion and mild traumatic brain injury (mTBI)
- Mackay Hospital activated as first clinical site on March 31, 2026
- Two additional sites in Melbourne and Adelaide expected to activate in Q2 2026
- Company plans to submit IND application to FDA in Q4 2026
Financial Impact
No immediate financial impact disclosed
Risk Factors
- Clinical trial may not demonstrate efficacy or safety
- FDA may not approve IND application
- Competition in concussion treatment market
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001493152-26-016294 |
| Exhibit: ex99-1.htm | 0001493152-26-016294 |
| Document: 0001493152-26-016294-index-headers.html | 0001493152-26-016294 |
| Document: 0001493152-26-016294-index.html | 0001493152-26-016294 |
| Document: 0001493152-26-016294.txt | 0001493152-26-016294 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Sep 16, 2026 5w ago | 8-K | $0.5000 $0.4469 | ▼ −10.62% | ▼ −13.80% | $0.4000 (−20.00%) |
Aug 28, 2026 8w ago | 8-K | $0.5098 $0.4800 | ▲ +5.85% | ▲ +5.66% | $0.4000 (+21.54%) |
May 20, 2026 22w ago | DEFA14A | $0.5900 $0.5882 | ▼ −0.31% | ▼ −0.64% | $0.4000 (−32.20%) |
May 19, 2026 22w ago | 8-K | $0.5700 $0.6100 | ▲ +7.02% | ▲ +6.03% | $0.4000 (−29.82%) |
May 7, 2026 24w ago | 8-K | $0.6100 $0.6100 | · 0.00% | ▼ −3.14% | $0.4000 (−34.43%) |
Apr 13, 2026 28w ago | 8-K | $0.6800 $0.5600 | ▼ −17.65% | ▼ −25.38% | $0.4000 (−41.18%) |
Mar 25, 2026 30w ago | Press Release | $0.5800 $0.6400 | ▼ −10.34% | ▲ +0.32% | $0.4000 (+31.03%) |
Mar 23, 2026 31w ago | EFFECT | $0.6800 $0.6600 | ▼ −2.94% | ▼ −10.36% | $0.4000 (−41.18%) |
Mar 11, 2026 32w ago | 8-K | $0.9600 $0.6000 | ▼ −37.50% | ▼ −39.48% | $0.4000 (−58.33%) |
Mar 11, 2026 32w ago | Press Release | $0.8800 $0.6200 | ▼ −29.55% | ▼ −30.07% | $0.4000 (−54.55%) |
US Market Status
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