Oragenics (NYSE American: OGEN) announced that all three sites in its Australian Phase IIa clinical trial of ONP-002 for mild traumatic brain injury (concussion) are now active and enrolling participants following the activation of Royal Adelaide Hospital. The company said no serious adverse events have been reported in dosed participants to date and it continues to target a Phase IIa data readout in the fourth quarter of 2026. Oragenics also announced it submitted a Type B meeting request to the U.S. Food and Drug Administration on June 26 to obtain guidance on its planned U.S. clinical development program for ONP-002. The company said the meeting supports its goal of submitting an Investigational New Drug application in the fourth quarter of 2026.
To view the full press release, visit https://ibn.fm/Yye2E
About Oragenics, Inc.
Oragenics, Inc. is a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology. The Company is working on advancing its lead candidate, ONP-002, as a potential first-in-class treatment for concussion and mild traumatic brain injury. Oragenics is working on commencing clinical trials in Australia for ONP-002 , with U.S. Phase 2b trials planned to follow. The Company’s intranasal delivery platform has potential applications across multiple neurological conditions, including Parkinson’s disease, Alzheimer’s disease, PTSD, and anxiety disorders. Oragenics is committed to developing innovative therapies that address significant unmet medical needs in neurological care. For more information, visit oragenics.com.
NOTE TO INVESTORS: The latest news and updates relating to OGEN are available in the company’s newsroom at https://ibn.fm/OGEN
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