Oragenics, Inc. (OGEN) has entered into a manufacturing agreement with Sterling Pharma Solutions for the GMP production of ONP-002, its intranasal drug candidate for treating concussions.
Sterling will manufacture the drug at its Cary, North Carolina, facility in preparation for Oragenics' planned Phase IIb clinical trials, expected to begin next year.
The partnership marks a key step in Oragenics' clinical development efforts, ensuring a domestic, GMP-compliant supply chain to support regulatory milestones. CEO Janet Huffman stated that the agreement reflects the company's commitment to U.S.-based innovation, quality, and efficiency as it advances ONP-002 through the trial process.
Sterling's Chief Commercial Officer, Chad Telgenhof, expressed confidence in their ability to support the clinical program, citing the company's CNS therapeutic expertise and timeline execution capabilities.
The deal aligns with Oragenics' broader goal of creating scalable, fast-acting treatments for neurological trauma, addressing an unmet need in concussion care where no FDA-approved pharmacological therapies currently exist.
OGEN currently trades at $1.38 or 2.9851% higher on the NYSE American.
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