Oragenics Inc OGEN
Oragenics Inc (NYSE: OGEN) is a CNS/neurology/psychiatry drug developer. Its lead program, ONP-002, is in Phase 2 for Mild traumatic brain injury (concussion). Its next catalyst on record is ONP-002: Submit US IND (FDA Type B meeting requested July 2026) (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: ONP-002 — Submit US IND (FDA Type B meeting requested July 2026) (Q4 2026). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| ONP-002 (intranasal powder neurosteroid) | Mild traumatic brain injury (concussion) | small molecule | Phase 2 |
Recent results and decisions
- Apr 13, 2026started First patient dosed in the randomized, placebo-controlled 40-patient Phase IIa trial of ONP-002 in concussion/mTBI at Mackay Hospital, Australia.
Oragenics, Inc. today announced that the first patient has been dosed in its ongoing Phase IIa clinical trial evaluating ONP-002, the Company's lead candidate for the treatment of concussion and mild traumatic brain injury (mTBI).
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.