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 - Mar 10, 2026n/a Oragenics received final Australian HREC (ethics committee) approval for its 40-patient Phase IIa trial of ONP-002 in concussion, with first patient dosing expected before end of March 2026.
Oragenics, Inc. today announced that it has received final Human Research Ethics Committee (HREC) approval in Australia to commence its Phase IIa clinical trial evaluating its lead drug candidate, ONP-002, for the treatment of concussion also known as 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.