Sedana Medical submits NDA to US FDA
It concerns isoflurane delivered via the Sedaconda ACD for ICU inhaled sedation. FDA filing review and acceptance decision are expected in about two months.
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Medtech and pharmaceutical company focused on inhaled sedation
sedanamedical.comLast updated
In short: Sedana submitted its New Drug Application to the FDA for inhaled sedation and appointed Mikael Haag as CFO to succeed Johan Spetz.
It concerns isoflurane delivered via the Sedaconda ACD for ICU inhaled sedation. FDA filing review and acceptance decision are expected in about two months.
No dividend was paid, and a performance-based incentive program for employees was approved.
The meeting is scheduled for 27 May 2026 at 4:00 pm in Danderyd. It includes proposals on board elections, remuneration, issue authorization, and LTI 2026 incentive program.
Net sales decreased 7% to MSEK 53.4. EBITDA turned positive at MSEK 1.8. NDA submission to FDA planned mid-2026.
Sedana Medical AB (publ) today announces that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the...
Sedana Medical AB is a medical technology company, which engages in the development, manufacture, and sale of medical devices and drug development for future projects...
The latest update is out from Sedana Medical AB ( (SE:SEDANA) ).
Based on the one-year price targets offered by 1 analyst, the average target price for Sedana Medical AB (OSTO:SEDANA) is $24.00 with a high estimate...
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