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Sedana Medical Achieves Positive FDA Pre-NDA Meeting for Inhaled Sedation

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Sedana Medical Achieves Positive FDA Pre-NDA Meeting for Inhaled Sedation

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The latest update is out from Sedana Medical AB ( (SE:SEDANA) ).

Sedana Medical AB has successfully completed a pre-New Drug Application (NDA) meeting with the FDA, achieving broad alignment on the contents of its NDA for inhaled sedation in mechanically ventilated adult patients. The FDA confirmed that the safety and efficacy data from Sedana’s clinical trials are adequate for submission, with additional analyses required for run-in training patients. The NDA submission is anticipated around mid-2026, marking a significant step towards entering the high-potential market for inhaled sedation.

The most recent analyst rating on (SE:SEDANA) stock is a Hold with a SEK9.00 price target. To see the full list of analyst forecasts on Sedana Medical AB stock, see the SE:SEDANA Stock Forecast page.

More about Sedana Medical AB

Sedana Medical AB is a pioneering medtech and pharmaceutical company specializing in inhaled sedation to enhance patient care during and after sedation. The company offers a combination of the Sedaconda ACD medical device and the Sedaconda (isoflurane) pharmaceutical for sedation of mechanically ventilated patients in intensive care. Sedana Medical operates with direct sales in several European countries and collaborates with external distributors in other regions. Founded in 2005, the company is listed on Nasdaq Stockholm and is headquartered in Stockholm, Sweden.

YTD Price Performance: -50.42%

Average Trading Volume: 254,803

Technical Sentiment Signal: Strong Sell

Current Market Cap: SEK939.7M

Find detailed analytics on SEDANA stock on TipRanks’ Stock Analysis page.

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