(RTTNews) - Oragenics (OGEN), a clinical-stage biotechnology company, on Tuesday reported the activation of a third site in Australia for the Phase 2a trial for ONP-002 for the treatment of mild traumatic brain injury (mTBI), or concussion.
ONP-002 is an intranasal neurosteroid developed for the treatment of mTBI. If proven successful, the drug may be the first FDA-approved therapy for mTBI.
The Royal Adelaide Hospital received approval to act as a testing site from the Research Governance Office (RGO) on June 29, 2026, joining Mackay Base Hospital and Alfred Health as the third and final site to be activated in the trial.
Additionally, the company submitted a request for a Type B meeting with the U.S. Food and Drug Administration (FDA) on June 26, 2026. The intended objective of the meeting is to gain guidance on the future clinical development of ONP-002.
Data readouts from the trial are expected in the fourth quarter of 2026, with an investigational new drug (IND) submission to the FDA also planned simultaneously.
OGEN closed Tuesday at $0.57, down 1.34%. In the afterhours trade, the stock rose 0.51% to $0.58.
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