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Oragenics seeks FDA approval for a concussion treatment, having also secured HREC approval in Australia.

1 report, 1 independent Updated Aug 11

AI-generated analysis. Brind wrote this summary from the reports listed below. It can be wrong. Each section says how much you can rely on it, and the sources are linked so you can check.

What happened

Some supportReported by 1 outlet

Who's involved

What this event is mainly about

FDA Oragenics (United States)

How it developed

Newest first. Tap a step to see who reported it.

Jun 8Oragenics secures a GMP production agreement with Sterling Pharma Solutions for its concussion drug candidate, ONP-002.Sub-event
Jun 8Oragenics (Q30291067) is conducting its clinical trials for a concussion treatment, utilizing Southern Star Research as the CRO and David Lloyd as the programme manager.Sub-event
Aug 11Oragenics is seeking FDA approval for a concussion treatment.1 source
- GlobeNewswire

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The entities involved

FDA
- Generic medicine services are seeking approval for launch from the FDA.Mon 17:49
- A company is seeking FDA feedback on its NEO212 program, with a meeting scheduled at the FDA's White Oak campus.Mon 14:56
Oragenics (United States)
company in Tampa, United States

Nothing else this week.

Related events

FDA provided responses to a Type B meeting request and Oragenics conducted a Phase IIa trial in Australia.Aug 28

Coverage

Newest first; wire copies grouped

Aug 11GlobeNewswireOragenics Q2 2025 Shareholder Update Advancing Brain-First Recovery Platform Toward Clinical Milestones Pioneering Intranasal Therapeutics for Concussion SARASOTA, Fla., Aug. 11, 2025 (GLOBE NEWSWIRE