Oragenics, Inc. (formerly Oragen Co., Ltd.) was established in November 1996, but its business activities did not start until 1999. The company is a developing company dedicated to the research and development of nasal drug delivery in the field of neurology and the fight against infectious diseases. The company's leading product, ONP-002, is a fully synthetic, non-naturally occurring neurosteroid that is lipophilic and can cross the blood-brain barrier, rapidly reducing swelling, oxidative stress and inflammation, while restoring proper blood flow through gene amplification. 

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Oragenics is focused on submitting an Investigational New Drug Application by the end of 2026. The company is reviewing several items and remains committed to advancing its product pipeline.

Oragenics

Oragenics Focused on Submitting Investigational New Drug Application by 2026

Oragenics reports continued progress in its Phase IIa clinical trial for ONP-002, an intranasal candidate for mTBI (concussion). Nine participants have been dosed across three active trial sites in Australia. The company has received responses from the FDA related to its Type B meeting request briefing package and remains focused on submitting an IND application by year-end. Oragenics has received a deficiency letter from NYSE American due to a lack of compliance with the company's equity requirements. The company has 45 days to submit a plan to regain compliance.

Oragenics Advances ONP-002 Trial, Eyes NYSE Listing and IND Approval

Oragenics continues to advance its Phase IIa clinical trial for ONP-002, an intranasal candidate for mild traumatic brain injury. The company has dosed nine participants across three Australian clinical sites and received responses from the US FDA related to its Type B meeting request briefing package. Oragenics is reviewing the FDA's items and aims to submit an IND application by the end of 2026. The company received a deficiency letter from NYSE American, citing non-compliance with continued listing standards due to losses in recent fiscal years. Oragenics has 45 days to submit a plan to regain compliance.

Oragenics Advances ONP-002 Trial, Receives FDA Responses, Faces NYSE Listing Issues

<p>Oragenics reports continued clinical progress, provides regulatory and NYSE American listing update</p>

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