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Oragenics Inc. reports developments as a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology. The company’s lead candidate, ONP-002, is an investigational intranasal neurosteroid being evaluated for concussion and mild traumatic brain injury, with updates centered on clinical trial operations, regulatory clearances, site activity and dosing milestones.
Company news also covers annual-report disclosures, operating and financial results, capital-structure actions, material agreements, shareholder voting matters and governance updates. Oragenics’ communications frequently connect its CNS strategy, intranasal delivery platform and public-company reporting obligations as an NYSE American-listed biotechnology issuer.
Oragenics (NYSE American: OGEN) reported active execution of its Phase IIa ONP-002 concussion trial in Australia, with multiple sites activated, enrollment underway, and zero serious adverse events to date.
The company is targeting a 2026 FDA IND filing, signed an LOI for a CNS device, and ended Q1 2026 with $6.1 million in cash.
Oragenics (NYSE American: OGEN) signed a non-binding Letter of Intent to license Sigyn Therapeutics' CardioDialysis™ blood‑purification technology for TBI and other neurodegenerative indications. The LOI contemplates 3,250,000 convertible restricted preferred shares to Sigyn, a 3% royalty for six years post-clearance, and a target close within 90 days subject to due diligence and approvals.
Strategic rationale: combining ONP-002 intranasal neurosteroid (crosses the blood‑brain barrier) with CardioDialysis™ (systemic inflammation clearance) to address TBI inflammation both centrally and peripherally.
Oragenics (NYSE American: OGEN) activated a second site, Alfred Hospital, in its Phase IIa study of ONP-002 for concussion and mild traumatic brain injury. Four patients have been dosed at Mackay Base Hospital; the trial plans to enroll 40 patients with first dosing within 12 hours.
Phase IIa data are projected before year-end 2026 and the company targets an IND submission for a Phase IIb U.S. trial by Dec 31, 2026.
Oragenics (NYSE American: OGEN) announced that 2 patients have been dosed and 8 study drug doses administered in its ongoing Phase IIa trial of ONP-002 for mild traumatic brain injury (mTBI) as of April 20, 2026.
The trial is designed to enroll 40 patients, with first dosing within 12 hours of concussion and treatment up to 30 days; Mackay Base Hospital is the first activated site and additional sites are finalizing activation.
Oragenics (NYSE: OGEN) announced dosing of the first patient in its Phase IIa trial of ONP-002 for concussion/mild traumatic brain injury at Mackay Hospital, Australia, within days of site activation on March 31, 2026. The randomized, placebo-controlled 40-patient study will dose within 12 hours of injury and continue treatment up to 30 days.
The company cited a Phase I safety profile with zero serious adverse events in 40 patients, HREC clearance in Australia, CRO support from Southern Star Research, and planned IND targeting in Q4 2026.
Oragenics (NYSE American: OGEN) announced receipt of an unqualified audit opinion on its consolidated financial statements, which included an explanatory paragraph about the Company’s ability to continue as a going concern. The Form 10-K for the year ended December 31, 2025 was filed March 16, 2026.
The announcement complies with NYSE American Company Guide Section 610(b) and does not amend or change the audited financial statements; supporting detail appears in footnote 1 of the 2025 consolidated financial statements. The 10-K is available on the SEC EDGAR system and the company’s investor relations website.
Oragenics (NYSE American: OGEN) filed its Form 10-K for the fiscal year ended December 31, 2025 and provided a shareholder update on 2025 milestones and Q1 2026 progress.
Key 2025 highlights include a $16.5 million capital raise, repayment of a $3.0 million promissory note, an 11% reduction in operating expenses, US cGMP manufacturing engagement, CRO contracting for a Phase IIa trial, and a partnership with Receptor.AI. Q1 2026 updates include HREC approval in Australia, initial site initiation visit, and IND readiness work with DUCK FLATS Pharma.
Oragenics (NYSE American: OGEN) completed the first site initiation visit for its Phase IIa trial of ONP-002 in Australia on March 12, 2026.
First SIV finished at one of three planned Australian sites; two remaining sites are completing Research Governance Office reviews after Human Research Ethics Committee approval. The randomized, placebo-controlled trial targets 40 patients, dosing within 12 hours of concussion onset, with primary endpoints around safety, neurocognitive assessments, and tolerability.
Oragenics (NYSE American: OGEN) is exploring acquisition of CNS assets focused on brain health and brain recovery to complement its intranasal delivery platform and lead candidate ONP-002.
ONP-002 Phase IIa is in active site initiation in Australia; Phase 1 showed safety in 40 patients with zero serious adverse events. No definitive acquisition agreements have been reached; any material transaction will be disclosed as required.
Oragenics (NYSE: OGEN) received final Human Research Ethics Committee (HREC) approval in Australia to begin a randomized, placebo-controlled Phase IIa trial of ONP-002 for concussion/mild traumatic brain injury. The trial will enroll 40 patients across three Australian sites, with first dosing expected before the end of March 2026 and a data readout projected before year-end 2026. Patients will receive first dosing within 12 hours of injury and up to 30 days of treatment; the company cites a Phase 1 safety profile with zero serious adverse events. Trial management is expected to be handled by Southern Star Research.