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WKN: A3CRAU | ISIN: SE0015988373 | Ticker-Symbol: 7D2A
Tradegate
24.04.25
17:01 Uhr
0,938 Euro
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MiSedana Medical AB: Sedana Medical Receives FDA Approval for Early Access Program in the U.S.57Sedana Medical AB (publ) today announced that the U.S. Food and Drug Administration (FDA) has approved the company's application to initiate an Early Access Program for its investigational inhaled sedation...
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13.02.Sedana Medical AB: Sedana Medical AB's Year-end report 2024119Primary endpoint met in both US trials and positive ex-US EBITDA excl. one-offs in Q4 Fourth quarter 2024Net sales for the quarter totalled MSEK 49.2 (44.5), equivalent to an increase of 10% compared...
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12.02.Sedana Medical AB: Sedana Medical announces positive high-level results also for its second pivotal trial in the United States168Sedana Medical AB (publ) announces that its second pivotal US trial INSPiRE-ICU 2 has met its primary endpoint, and hence established non-inferiority of inhaled sedation with isoflurane compared with...
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03.02.Sedana Medical AB: Sedana Medical receives an additional year of market protection for Sedaconda (isoflurane)285Sedana Medical AB (publ) announces that Sedaconda® (isoflurane) has received an additional year of market protection, extending the protection period until 2032. The decision is based on the regulatory...
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19.12.24Sedana Medical AB: Sedana Medical announces positive high-level results of its first pivotal trial in the United States (INSPiRE-ICU 1)232Sedana Medical AB (publ) announces that its first pivotal US trial INSPiRE-ICU 1 has met its primary endpoint: to prove that inhaled sedation with isoflurane is an effective sedation method by establishing...
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24.10.24Sedana Medical AB: Sedana Medical AB's Interim report January-September 2024161Raising our 2024 sales guidance and integrating our European trial into the US submission - strengthening our file, but extending timelines Third quarter 2024Net sales for the quarter totaled MSEK 39.7...
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23.07.24Sedana Medical AB: Sedana Medical AB's Interim report January-June 2024176Enrolment of both US clinical trials completed, on track for first results in 2H. Second quarter 2024 Net sales for the quarter totaled MSEK 41.1 (37.3), equivalent to an increase of 10% compared...
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22.07.24Sedana Medical AB: Sedana Medical to acquire its main supplier to take control of supply chain and reduce cost of goods309Sedana Medical AB (publ) announces it has today entered into an agreement to acquire Innovatif Cekal, the supplier of the company's main product (Sedaconda ACD). The acquisition will enable better control...
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29.05.24Sedana Medical completes patient recruitment for its clinical program in the US343STOCKHOLM, May 29, 2024 /PRNewswire/ -- Sedana Medical AB (publ) announces that all 235 randomized patients have been recruited for its INSPiRE-ICU 2 phase III clinical trial in the United...
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