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Oragenics

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Neutral
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Sentiment 3-Months
Positive
Neutral 100%
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Neutral
GlobeNewsWire
7 days ago
Oragenics Doses First Patient in Phase IIa Clinical Trial of ONP-002 for Mild Traumatic Brain Injury
SARASOTA, Fla., April 13, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology, today announced that the first patient has been dosed in its ongoing Phase IIa clinical trial evaluating ONP-002, the Company's lead candidate for the treatment of concussion and mild traumatic brain injury (mTBI). The milestone was achieved at Mackay Hospital in Australia — the first site to be activated in the trial — within days of site activation on March 31, 2026.
Oragenics Doses First Patient in Phase IIa Clinical Trial of ONP-002 for Mild Traumatic Brain Injury
Neutral
GlobeNewsWire
25 days ago
Oragenics, Inc. Receives Audit Opinion with Going Concern Explanation
SARASOTA, Fla., March 25, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company pioneering brain-targeted therapeutics through proprietary intranasal delivery technology, announced that, as previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2025, which was filed on March 16, 2026 with the Securities and Exchange Commission, the audited consolidated financial statements contained an unqualified audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to the Company's ability to continue as a going concern. See further discussion in footnote 1 to the Company's consolidated financial statements included in the Company's Annual Report on Form 10-K. This announcement is made pursuant to NYSE American LLC Company Guide Section 610(b), which requires public announcement of the receipt of an audit opinion containing a going concern paragraph. This announcement does not represent any change or amendment to the Company's financial statements or to its Annual Report on Form 10-K for the year ended December 31, 2025.
Oragenics, Inc. Receives Audit Opinion with Going Concern Explanation
Neutral
GlobeNewsWire
1 month ago
ORAGENICS INITIATES PHASE IIA CLINICAL TRIAL SITE ACTIVATION
FIRST SITE INITIATION VISIT COMPLETED IN AUSTRALIA SARASOTA, Fla., March 12, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company pioneering brain-targeted therapeutics through proprietary intranasal delivery technology, today announced it has completed the first site initiation visit (SIV) for its Phase IIa clinical trial of ONP-002 in Australia.
ORAGENICS INITIATES PHASE IIA CLINICAL TRIAL SITE ACTIVATION
Neutral
GlobeNewsWire
1 month ago
ORAGENICS EXPLORES EXPANSION OF CNS PLATFORM PURSUING ACQUISTION OF ASSETS IN BRAIN HEALTH, RECOVERY, AND NEUROPROTECTION
SARASOTA, Fla., March 11, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company pioneering brain-targeted therapeutics through proprietary intranasal delivery technology, today announced that it is exploring discussions with third parties regarding the potential acquisition of additional assets in the central nervous system (CNS) space, with a specific focus on brain health and brain recovery indications that demonstrate strategic synergies with the Company's lead candidate ONP-002 and its proprietary intranasal drug delivery platform.
ORAGENICS EXPLORES EXPANSION OF CNS PLATFORM PURSUING ACQUISTION OF ASSETS IN BRAIN HEALTH, RECOVERY, AND NEUROPROTECTION
Neutral
GlobeNewsWire
1 month ago
Oragenics Receives HREC Approval for Phase IIa Clinical Trial of ONP-002 as a Treatment for Concussion and Mild Traumatic Brain Injury in Australia
All required regulatory approvals secured for trial site onboarding and patient enrollment at three Australian sites Potential first and only pharmacological treatment for the most prominent neurological condition without an FDA-approved therapeutic
Oragenics Receives HREC Approval for Phase IIa Clinical Trial of ONP-002 as a Treatment for Concussion and Mild Traumatic Brain Injury in Australia
Neutral
GlobeNewsWire
2 months ago
Oragenics Targets Projected $9 Billion Market by Advancing First and Only Clinical-Stage Concussion and Mild Traumatic Brain Injury Therapy
Outlines clinical and growth catalysts for ONP-002 in concussion and mild traumatic brain injury (mTBI)  Fully prepared to initiate near-term clinical site onboarding and first patient dosing in Australia Sarasota, Fla., Feb. 09, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) (“the “Company”) a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology, today previewed its targeted milestones for 2026.
Oragenics Targets Projected $9 Billion Market by Advancing First and Only Clinical-Stage Concussion and Mild Traumatic Brain Injury Therapy
Neutral
GlobeNewsWire
2 months ago
Oragenics Partners with DUCK FLATS Pharma to Support FDA IND Readiness and Clinical Trial Design for Concussion Program
Collaboration reinforces regulatory diligence, nonclinical strategy and clinical trial integrity for novel intranasal concussion therapy
Oragenics Partners with DUCK FLATS Pharma to Support FDA IND Readiness and Clinical Trial Design for Concussion Program
Neutral
Business Wire
5 months ago
Oragenics Q3 2025 Shareholder Update
SARASOTA, Fla.--(BUSINESS WIRE)--Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology, today reported key operational, financial, and strategic achievements for the third quarter of 2025. These milestones reflect the Company's evolution from vision to execution as it advances toward critical clinical trial initiation in Q4 2025/Q1 2026. OPERATIONAL EXCELLENCE: FOUNDATION RESTORED N.
Oragenics Q3 2025 Shareholder Update
Neutral
Business Wire
6 months ago
Oragenics Regains Full NYSE American Compliance, Company Resolves Stockholder Equity Deficiency
SARASOTA, Fla.--(BUSINESS WIRE)--Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology, announced today that it has regained full compliance with NYSE American's continued listing standards and is positioning the Company to focus exclusively on advancing its lead clinical program. NYSE Compliance Regained Effective October 20, 2025, the NYSE American notified Oragenics that the Comp.
Oragenics Regains Full NYSE American Compliance, Company Resolves Stockholder Equity Deficiency
Neutral
Business Wire
6 months ago
Oragenics Announces Strategic Partnership with Receptor.AI to Accelerate Pipeline Development
SARASOTA, Fla.--(BUSINESS WIRE)--Oragenics, a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology, today announced a strategic collaboration with Receptor.AI, an artificial intelligence-driven drug profiling company, to accelerate the potential development of an expanded pharmaceutical-candidate portfolio for potential conditions affecting brain health. This partnership represents a significant milestone in Oragenics' ev.
Oragenics Announces Strategic Partnership with Receptor.AI to Accelerate Pipeline Development