Oragenics (OGEN)
Developing an intranasal concussion treatment candidate through outsourced clinical development.
Oragenics Reports Continued Clinical Progress, Provides Regulatory and NYSE American Listing Update
SARASOTA, Fla., Aug. 28, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biopharmaceutical company developing brain-targeted therapeutics through its proprietary intranasal delivery platform, today provided an update on its Phase IIa clinical trial, U.S. regulatory pathway, and NYSE American continued listing status.
Oragenics (NYSEAMERICAN:OGEN) Trading Up 0.2% – Time to Buy?
Shares of Oragenics, Inc. (NYSEAMERICAN:OGEN - Get Free Report) traded up 0.2% on Tuesday. The stock traded as high as $0.5490 and last traded at $0.5489. 31,024 shares changed hands during mid-day trading, an increase of 28% from the average daily volume of 24,280 shares. The stock had previously closed at $0.5480. Oragenics Trading
Oragenics Achieves Full Activation of Australian Phase IIa Trial Network — All Three Sites Now Enrolling
Company also advances U.S. regulatory pathway for ONP-002 with FDA Type B meeting request All three Australian Phase IIa trial sites — Mackay Base Hospital, Alfred Health, and Royal Adelaide Hospital — are now active and enrolling, following Royal Adelaide Hospital's Research Governance Office (RGO) approval Alfred Health enrolls first participant in the Phase IIa clinical trial Company submits Type B meeting request to the U.S. Food and Drug Administration (FDA), advancing the U.S. regulatory pathway for ONP-002 SARASOTA, Fla., July 07, 2026 (GLOBE NEWSWIRE) -- Oragenics (NYSE American: OGEN), a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology, today announced that all three sites in its Australian Phase IIa clinical trial are now active and enrolling — alongside continued progress on its U.S. regulatory program for ONP-002, being evaluated for the treatment of mTBI (concussion).
Oragenics to Present at Sidoti's Micro-Cap Virtual Investor Conference May 20-21
Sarasota, FL, May 19, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) ("Oragenics" or the "Company"), a clinical-stage biopharmaceutical company pioneering neurological therapeutics, will present and host one-on-one meetings with investors at Sidoti's Micro-Cap Virtual Investor Conference, taking place on May 20-21, 2026.
ORAGENICS PROVIDES INVESTOR UPDATE
A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER Sarasota, FL, May 18, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) Dear Fellow Shareholders, Since our last investor update, Oragenics has continued to execute across all fronts — in the clinic, in the regulatory pipeline, on our balance sheet, and strategically. We have reached a pivotal moment: our Phase IIa clinical trial of ONP-002 is active in Australia, patients are being enrolled and dosed, and we have now signed a Letter of Intent to pursue a licensing agreement for a complementary CNS-related medical device.
Oragenics Signs Letter of Intent to License CardioDialysis™ Technology from Sigyn Therapeutics to Target TBI-Induced Systemic Inflammation
The Expected License Agreement Would Position Oragenics as the Only Company with Therapeutic Strategies Targeting TBI-Induced Inflammation on Both Sides of the Blood-Brain Barrier Sarasota, FL and San Diego, CA, May 07, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) ("Oragenics" or the "Company"), a clinical-stage biopharmaceutical company pioneering neurological therapeutics, and Sigyn Therapeutics, Inc.
Oragenics Signs Letter of Intent to License CardioDialysis™ Technology from Sigyn Therapeutics to Target TBI-Induced Systemic Inflammation
The Expected License Agreement Would Position Oragenics as the Only Company with Therapeutic Strategies Targeting TBI-Induced Inflammation on Both Sides of the Blood-Brain Barrier
Oragenics Activates Second Site in Phase IIa Clinical Trial of ONP-002 for Concussion and Mild Traumatic Brain Injury.
SARASOTA, Fla., May 05, 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 Alfred Hospital is now actively enrolling participants 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). To date, four patients have been enrolled and dosed at Mackay Base Hospital in Queensland, Australia, the first site activated in the trial.
Oragenics Reports 8 study drug doses in Phase IIa Clinical Trial of ONP-002 for Mild Traumatic Brain Injury
• Enrollment underway at Mackay Base Hospital in Queensland, Australia; additional sites in final activation stages SARASOTA, Fla. , April 20, 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 2 patients and 8 study drug doses have been administered in its ongoing Phase IIa clinical trial evaluating ONP-002, the Company's lead candidate for the treatment of mild traumatic brain injury (mTBI) a.
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.
Short Interest in Oragenics, Inc. (NYSEAMERICAN:OGEN) Rises By 39.0%
Oragenics, Inc. (NYSEAMERICAN:OGEN - Get Free Report) was the recipient of a significant increase in short interest during the month of March. As of March 13th, there was short interest totaling 792,779 shares, an increase of 39.0% from the February 26th total of 570,220 shares. Based on an average daily trading volume, of 442,572 shares,
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 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 (NYSEAMERICAN:OGEN) Trading Down 0.3% – Here’s Why
Shares of Oragenics, Inc. (NYSEAMERICAN:OGEN - Get Free Report) fell 0.3% during mid-day trading on Tuesday. The company traded as low as $0.7839 and last traded at $0.8295. 74,417 shares traded hands during mid-day trading, a decline of 82% from the average session volume of 421,599 shares. The stock had previously closed at $0.8317.
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 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 to Participate in SCOPE Summit 2026 Focused on Advancing Clinical Research and Patient Care
Management to Engage with Global Clinical Research Leaders Ahead of Phase 2a Trial of Concussion Treatment Sarasota, Fla. , Feb. 02, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) ("the "Company"), a clinical-stage biotechnology company focused on developing intranasal therapeutics for neurological disorders, today announced its participation at the SCOPE Summit 2026, the 17th annual conference organized by the Cambridge Healthtech Institute.
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 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 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.