Oragenics, Inc. Announces U.S.-Based Drug Manufacturing Agreement to Support ONP-002 Clinical Development
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jul 16 2025
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Source: Newsfilter
Manufacturing Agreement: Oragenics, Inc. has partnered with Sterling Pharma Solutions for the GMP production of its lead drug candidate, ONP-002, aimed at treating concussions, ahead of planned Phase IIb clinical trials expected to start next year.
Strategic Development: This collaboration enhances Oragenics' strategy to develop effective treatments for neurological trauma, particularly mild traumatic brain injury (mTBI), leveraging U.S.-based manufacturing capabilities and expertise in CNS therapies.
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About OGEN
Oragenics, Inc. is a development-stage company. It is engaged in the research and development of nasal delivery pharmaceutical medications in neurology and fighting infectious diseases. It focuses on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases, including drug candidates for treating mild traumatic brain injury (mTBI or Concussion), and for treating Niemann Pick Disease Type C (NPC), and proprietary powder formulation and an intranasal delivery device. Its lead product, ONP-002, is a fully synthetic, non-naturally occurring neurosteroid, is lipophilic, and can cross the blood-brain barrier to rapidly reduce swelling, oxidative stress and inflammation while restoring proper blood flow through gene amplification. It is also focused on developing medical products that treat brain related illnesses and diseases (the Neurology Assets). Its other product candidate, ONP-001, is in its early stage and clinical trials.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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