Ondine Biomedical Inc.

US FDA NDA submission

Includes Equity fundraise – Completed; £10m raised, admission 23 October, closed 20 Oct 2026

After positive LANTERN Phase 3 topline results (1 Sep 2026), Ondine is completing the clinical study report and the remaining NDA components. It targets a pre-NDA FDA meeting in Q1 2027 and NDA submission in mid-2027. The £10m raise completed on 20 October 2026 funds this work, with about 20% for US regulatory activities. On 23 Oct 2026 Ondine reported real-world Ottawa Heart Institute data as supportive evidence; no change to the NDA timetable.

Next milestone

Pre-NDA meeting with the FDA in Q1 2027 23 Oct 2026 ↗

Submission

NDA submission planned mid-2027 23 Oct 2026 ↗

Designations

QIDP and Fast Track; expedited six-month FDA review goal 23 Oct 2026 ↗

Funding

£10m raise completed 20 October 2026; c.20% of proceeds for US regulatory activities 23 Oct 2026 ↗

Further funding

More funding needed for US launch, subject to FDA approval 23 Oct 2026 ↗

Supporting data

LANTERN: 5,188 patients, 40.5% relative reduction in 30-day SSIs; Ottawa real-world CABG data reported 23 Oct 2026 23 Oct 2026 ↗

Next: Pre-NDA meeting with the FDA

1. 23 Oct 2026 Funded; preparing NDA for mid-2027
2. 20 Oct 2026 Funded; preparing NDA for mid-2027
3. 19 Oct 2026 Preparing NDA after positive LANTERN results