Sedana Medical AB-NDA submission finally in – US market in sight-06/17/2026

Research evidence excerpt

Sedana Medical AB-NDA submission finally in – US market in sight-06/17/2026

Sedana Medical AB

NEWSFLASH | 17 JUN 2026

NDA submission finally in – US market in sight

Sedana just submitted the NDA to the FDA. Next is a 60-day filing review, during which the FDA decides whether the

application is complete enough to be accepted. If accepted, a PDUFA date will be assigned marking the deadline for a final

decision. Standard review time is 10 months, meaning a decision can be expected during the spring of 2027. This is an

important milestone, especially given the repeated delays over the years. The application is now with the FDA, and the

timeline no longer depends on Sedana. We would not be surprised to see shares up substantially today. We have a Buy

rating and a TP of SEK 18.

Filip Wiberg

+46 73 045 6771, filip.wiberg@paretosec.com

Christian Lee

+46 84 02 52 67, christian.lee@paretosec.com

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