Oragenics Inc. has announced key regulatory progress in its pursuit to advance its lead candidate, ONP-002, aimed at becoming the first FDA-approved pharmacological treatment for concussion. During the second quarter of 2025, the company secured Human Research Ethics Committee (HREC) approval in Australia, marking a significant milestone in their clinical development. Additionally, Oragenics has finalized a US-based cGMP manufacturing agreement with Sterling Pharma Solutions, ensuring reliable, scalable production to support successful clinical execution and future commercial readiness. These strategic advancements are part of Oragenics' broader mission to revolutionize neurotrauma care through its pioneering brain-targeted therapeutics and proprietary intranasal delivery technology.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Oragenics Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001641172-25-022908), on August 11, 2025, and is solely responsible for the information contained therein.
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