Oragenics IncActivation of third trial site and FDA meeting request advance ONP-002 development for mTBI, with potential to be first approved therapy.

Oragenics has activated a third site in Australia for its Phase 2a trial of ONP-002, an intranasal neurosteroid for treating mild traumatic brain injury. The Royal Adelaide Hospital received approval on June 29, 2026, joining Mackay Base Hospital and Alfred Health as the third and final site in the trial. The company also submitted a request for a Type B meeting with the U.S. FDA on June 26, 2026 to gain guidance on future clinical development. Data readouts are expected in the fourth quarter of 2026, with an IND submission planned simultaneously. If successful, ONP-002 could become the first FDA-approved therapy for mTBI.
Oragenics IncActivation of third trial site and FDA meeting request advance ONP-002 development for mTBI, with potential to be first approved therapy.