NetworkNewsBreaks – Oragenics Inc. (NYSE American: OGEN) Advances Phase IIa Concussion Trial, Provides FDA and Listing Updates
Oragenics (NYSE American: OGEN), a clinical-stage biopharmaceutical company developing brain-targeted therapeutics through its proprietary intranasal delivery platform, provided updates on its Phase IIa feasibility trial of ONP-002 for mild traumatic brain injury (“mTBI”), its U.S. regulatory pathway and NYSE American continued listing status. The company has dosed nine participants across three active Australian clinical sites — Alfred Health, Mackay and Royal Adelaide Hospital — and has received responses from the U.S. Food and Drug Administration (“FDA”) related to its Type B meeting request briefing package submitted in July 2026. Oragenics is reviewing the FDA responses and remains focused on submitting an Investigational New Drug (“IND”) application by the end of 2026.
Oragenics also reported receiving an NYSE American deficiency letter on Aug. 26, 2026, related to stockholders’ equity requirements under Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide. The company has 45 days from receipt of the letter to submit a plan to regain compliance and intends to do so within the required timeframe. If accepted, the plan would allow Oragenics to maintain its listing during a cure period, subject to periodic review, with a compliance deadline of Feb. 25, 2028.
To view the full press release, visit https://nnw.fm/HZ5fb
NOTE TO INVESTORS: The latest news and updates relating to OGEN are available in the company’s newsroom at https://nnw.fm/OGEN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
Oragenics (NYSE American: OGEN), a clinical-stage biopharmaceutical company developing brain-targeted therapeutics through its proprietary intranasal delivery platform, provided updates on its Phase IIa feasibility trial of ONP-002 for mild traumatic brain injury (“mTBI”), its U.S. regulatory pathway and NYSE American continued listing status. The company has dosed nine participants across three active Australian clinical sites — Alfred Health, Mackay and Royal Adelaide Hospital — and has received responses from the U.S. Food and Drug Administration (“FDA”) related to its Type B meeting request briefing package submitted in July 2026. Oragenics is reviewing the FDA responses and remains focused on submitting an Investigational New Drug (“IND”) application by the end of 2026.
Oragenics also reported receiving an NYSE American deficiency letter on Aug. 26, 2026, related to stockholders’ equity requirements under Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide. The company has 45 days from receipt of the letter to submit a plan to regain compliance and intends to do so within the required timeframe. If accepted, the plan would allow Oragenics to maintain its listing during a cure period, subject to periodic review, with a compliance deadline of Feb. 25, 2028.
To view the full press release, visit https://nnw.fm/HZ5fb
NOTE TO INVESTORS: The latest news and updates relating to OGEN are available in the company’s newsroom at https://nnw.fm/OGEN
Please see full terms of use and disclaimers on the NetworkNewsWire website applicable to all content provided by NNW, wherever published or republished: http://NNW.fm/Disclaimer
