News · 26 weeks30-56%
2025-10-262026-04-19
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25 items- PROragenics 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: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.k.a., concussion. Enrollment is progressing at Mackay Base Hospital in Queensland, Australia, the first activated site in the trial, with addition
- SECOragenics Inc. filed SEC Form 8-K: Other Events, Financial Statements and Exhibits8-K - ORAGENICS INC (0001174940) (Filer)
- PROragenics Doses First Patient in Phase IIa Clinical Trial of ONP-002 for Mild Traumatic Brain InjuryMackay Base Hospital activated March 31, 2026 as first clinical trial site; first patient dosed within days of activation — a signal of strong enrollment velocity and significant unmet medical need SARASOTA, Fla., April 13, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE: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 sit
- SECOragenics Inc. filed SEC Form 8-K: Shareholder Director Nominations, Financial Statements and Exhibits8-K - ORAGENICS INC (0001174940) (Filer)
- PROragenics, Inc. Receives Audit Opinion with Going Concern ExplanationSARASOTA, Fla., March 25, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE: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
- SECSEC Form EFFECT filed by Oragenics Inc.EFFECT - ORAGENICS INC (0001174940) (Filer)
- SECAmendment: SEC Form S-3/A filed by Oragenics Inc.S-3/A - ORAGENICS INC (0001174940) (Filer)
- PRORAGENICS FILES ANNUAL REPORT ON FORM 10-KREPORTS YEAR OF STRATEGIC TRANSFORMATION AND CLINCIAL ADVANCEMENT SARASOTA, Fla., March 17, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE:OGEN), a clinical-stage biotechnology company pioneering brain-targeted therapeutics through proprietary intranasal delivery technology, today announced the filing of its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, with the U.S. Securities and Exchange Commission. In conjunction with this filing, the Company is providing a shareholder update on key operational and clinical milestones achieved during 2025 and progress made in the first quarter of 2026. The Annual Report on Form 10-K, including audited financial statements fo
- SECSEC Form 10-K filed by Oragenics Inc.10-K - ORAGENICS INC (0001174940) (Filer)
- PRORAGENICS INITIATES PHASE IIA CLINICAL TRIAL SITE ACTIVATIONFIRST SITE INITIATION VISIT COMPLETED IN AUSTRALIA SARASOTA, Fla., March 12, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE: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. The visit marks the formal launch of clinical trial operations at the first of three planned trial sites in Australia, including completion of site staff training, protocol orientation, and site regulatory documentation. The remaining two clinical trial sites are currently completing their Research Govern
- SECSEC Form 8-K filed by Oragenics Inc.8-K - ORAGENICS INC (0001174940) (Filer)
- PRORAGENICS EXPLORES EXPANSION OF CNS PLATFORM PURSUING ACQUISTION OF ASSETS IN BRAIN HEALTH, RECOVERY, AND NEUROPROTECTIONSARASOTA, Fla., March 11, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE: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. The Company's portfolio expansion initiative is being pursued independently of its existing partnership with Recepto
- PROragenics Receives HREC Approval for Phase IIa Clinical Trial of ONP-002 as a Treatment for Concussion and Mild Traumatic Brain Injury in AustraliaAll required regulatory approvals secured for trial site onboarding and patient enrollment at three Australian sitesPotential first and only pharmacological treatment for the most prominent neurological condition without an FDA-approved therapeutic SARASOTA, Fla., March 10, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE:OGEN), a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology, today announced that it has received final Human Research Ethics Committee (HREC) approval in Australia to commence its Phase IIa clinical trial evaluating its lead drug candidate, ONP-002, for the treatment of concussion also known as mi
- PROragenics to Participate in SCOPE Summit 2026 Focused on Advancing Clinical Research and Patient CareManagement 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: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. SCOPE (Summit for Clinical Ops Executives) is a clinical research conference being held February 2–5, 2026, in Orlando, Florida. "Oragenics is excited to participate in one of the premier global conferences for clinical operations and optimal t
- SECSEC Form S-3 filed by Oragenics Inc.S-3 - ORAGENICS INC (0001174940) (Filer)
- SECOragenics Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Financial Statements and Exhibits8-K - ORAGENICS INC (0001174940) (Filer)
- INSIDERAmendment: Director Telling Fred sold $198 worth of shares (210 units at $0.94), decreasing direct ownership by 18% to 948 units (SEC Form 4)4/A - ORAGENICS INC (0001174940) (Issuer)
- SECOragenics Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits8-K - ORAGENICS INC (0001174940) (Filer)
- PROragenics to Present at the 2026 Sequire Investor Summit in Puerto RicoSarasota, Fla., Jan. 14, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE:OGEN) ("the "Company") today announced that it will be presenting at the upcoming Sequire Investor Summit 2026. The fourth edition of the Sequire Investor Summit is scheduled for January 20th-22nd, 2026, at the Condado Vanderbilt Hotel in San Juan, Puerto Rico. "We appreciate the opportunity to present at the Sequire Investor Summit and discuss our novel approach to addressing the significant unmet medical need in concussion and mild traumatic brain injury," said Janet Huffman, CEO of Oragenics. "There are currently no approved drug therapies for concussion, underscoring the importance of advancing our ONP-002 clinica
- INSIDERSEC Form 4 filed by CEO and CFO Huffman Janet4 - ORAGENICS INC (0001174940) (Issuer)
- INSIDERSEC Form 4 filed by Director Giordano Natasha4 - ORAGENICS INC (0001174940) (Issuer)
- INSIDERDirector Telling Fred sold $198 worth of shares (210 units at $0.94), decreasing direct ownership by 0.60% to 34,538 units (SEC Form 4)4 - ORAGENICS INC (0001174940) (Issuer)
- INSIDERSEC Form 4 filed by Director Gandolfo John P4 - ORAGENICS INC (0001174940) (Issuer)
- INSIDERSEC Form 4 filed by Director Dunton Alan W4 - ORAGENICS INC (0001174940) (Issuer)
- INSIDERSEC Form 4 filed by Director Koski Robert C4 - ORAGENICS INC (0001174940) (Issuer)