Oragenics Targets Projected $9 Billion Market by Advancing First and Only Clinical-Stage Concussion and Mild Traumatic Brain Injury Therapy (Globe Newswire)

UF Innovate | Accelerate graduate Oragenics, Inc. outlined its 2026 milestones as it advances ONP-002, a novel intranasal neurosteroid in clinical development for concussion and mild traumatic brain injury.
Oragenics Partners With DUCK FLATS Pharma To Support FDA IND Readiness and Clinical Trial Design for Concussion Program (Globe Newswire)

UF Innovate | Accelerate graduate Oragenics announced it has engaged DUCK FLATS Pharma as its U.S. Investigational New Drug (IND) readiness and regulatory execution partner to support FDA-facing preparation and clinical trial design as the Company advances its novel intranasal concussion therapy toward U.S.-based development.
Oragenics Announces Strategic Partnership With Receptor.AI To Accelerate Pipeline Development (Oragenics)

UF Innovate | Accelerate graduate Oragenics announced a strategic collaboration with Receptor.AI, an artificial intelligence-driven drug profiling company, to accelerate the potential development of an expanded pharmaceutical-candidate portfolio for potential conditions affecting brain health.
Oragenics Selects Southern Star Research As Clinical Research Organization for ONP-002 Phase IIa Trial

UF Innovate | Accelerate graduate Oragenics, Inc., announced the selection of Southern Star Research as its Clinical Research Organization (CRO) for the upcoming Phase IIa clinical trial of ONP-002, the company’s lead drug candidate for concussion.
Oragenics, Inc. Announces U.S.-Based Drug Manufacturing Agreement To Support ONP-002 Clinical Development

UF Innovate | Accelerate graduate Oragenics, Inc., has announced a manufacturing agreement with Sterling Pharma Solutions, a leading U.S.-based CDMO with multiple development and production facilities.
Oragenics, Inc. Announces Approval To Initiate Phase II Concussion Drug Trial in Australia
UF Innovate | Accelerate graduate Oragenics announced that it has received approval from the Human Research Ethics Committee (HREC) in Australia to initiate a Phase II clinical trial evaluating ONP-002 for the treatment of mild traumatic brain injury (mTBI).
Oragenics, Inc. To Participate at the 15th Annual Traumatic Brain Injury Conference
UF Innovate | Accelerate graduate Oragenics, Inc., a biotechnology company developing novel intranasal therapies for concussion and other brain-related conditions, announced its participation in the 15th Annual Traumatic Brain Injury Conference.
Oragenics, Inc. Announces Health and Disability Ethics Committee Submission for Phase IIa Concussion Trial
UF Innovate | Accelerate graduate Oragenics announced that it has submitted a clinical trial protocol for regulatory review to the Health and Disability Ethics Committee (HDEC) in New Zealand.
Oragenics, Inc. Submits Investigator’s Brochure for Phase II Clinical Trial of ONP-002 in Mild Traumatic Brain Injury
UF Innovate | Accelerate graduate Oragenics, Inc. announced the submission of its Investigator’s Brochure (IB) application in preparation for its Phase II clinical trial using ONP-002 in Australia.
Oragenics, Inc. Announces Partnership With BRAINBox Solutions To Revolutionize Concussion Diagnosis and Treatment
UF Innovate | Accelerate graduate Oragenics, Inc., a biotechnology company advancing innovative treatments for concussion and brain-related health conditions, announced a strategic partnership with BRAINBox Solutions, a leader in multi-modality diagnostics for traumatic brain injury (TBI).