OGEN Oragenics

Oragenics CMO to present ONP-002 at IPAC-RS 2026 Nasal Innovation Forum

Oragenics announced that its CMO will present ONP-002 intranasal delivery platform and Phase IIa trial design at the IPAC-RS 2026 Nasal Innovation Forum on September 17, 2026. The presentation is expected to cover clinical translation and anticipated U.S. development path. The company also stated IND submission is anticipated in Q4 2026.

Oragenics activates first Australian Phase IIa sites for ONP-002

The document reports that the Phase IIa randomized, placebo-controlled feasibility study of ONP-002 is now active in Australia, with Mackay Base Hospital activated March 31, 2026 and first patient dosed, and Alfred Hospital activated in April 2026. This advances the regulatory and clinical path from planned to ongoing execution, with additional site activations and U.S. IND milestones still ahead.

Oragenics doses first patient in Phase IIa ONP-002 mTBI trial

The first patient has been dosed in the Phase IIa trial of ONP-002 at Mackay Base Hospital, Australia, marking the start of clinical evaluation. Two additional Australian sites are expected to activate in Q2 2026. The company plans to submit an IND to the FDA in Q4 2026 to enable U.S. Phase IIb trials.

Oragenics receives HREC approval for ONP-002 Phase IIa trial in Australia

HREC approval clears the company to begin site onboarding and patient enrollment at three Australian sites. First patient dosing is expected before the end of March 2026. Phase IIa data readout is projected before year-end 2026 and will support a planned U.S. IND submission.