FDA minutes confirm positive outcome of meeting on 9 September 2025 — Corticorelin on track for Phase 3

Liestal, Switzerland, 18 September 2025: Curatis Holding AG (SIX: CURN) has received the official minutes from the US FDA confirming the positive outcome of the Type B meeting held on 9 September 2025.

The FDA minutes confirm that a single pivotal Phase 3 study in peritumoral brain edema (PTBE) will be sufficient to support a Biologic License Application (BLA) for corticorelin in the US. The FDA further confirmed that the study may be initiated without prior Phase 2 data.

Curatis is now preparing the Phase 3 study and will provide further updates on the timeline.