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Santhera Pharmaceuticals Holding AG (0QN1.L)

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  • Globe Newswire

    Santhera Submits Marketing Authorization Application to the European Medicines Agency for Vamorolone in Duchenne Muscular Dystrophy

    Pratteln, Switzerland, October 3, 2022 – Santhera Pharmaceuticals (SIX: SANN) announces that the Company has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for vamorolone for the treatment of Duchenne muscular dystrophy (DMD). At the core of the MAA submission are positive data from the pivotal Phase 2b VISION-DMD study which comprised a (1) 24-week period to demonstrate efficacy and safety of vamorolone (2 and 6 mg/kg/day) versus prednisone (0.75 mg

  • Globe Newswire

    Santhera Announces Preliminary 2022 Half-year Financial Results Ahead of Full Report Publication by End of October

    Ad hoc announcement pursuant to Art. 53 LR Pratteln, Switzerland, September 29, 2022 – Santhera Pharmaceuticals (SIX: SANN) publishes preliminary financial results for the half-year ended June 30, 2022. Santhera also announces the amendment of its existing financing arrangement with certain funds managed by Highbridge Capital Management, LLC (“Highbridge”), providing for immediate disbursement of a CHF 10 million tranche and making a further CHF 10 million tranche available, subject to certain m

  • Globe Newswire

    JAMA Neurology Publishes Positive Pivotal Clinical Trial with Vamorolone in Duchenne Muscular Dystrophy

    Results from the VISION-DMD study showing efficacy and safety of vamorolone compared to placebo and to standard of care, prednisone, has been published in JAMA NeurologySafety analysis on bone biomarkers and growth showed no negative effects of vamoroloneRegulatory filings for vamorolone with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are planned to be completed in Q3-2022 and Q4-2022, respectively Pratteln, Switzerland, and Rockville, MD, USA, September