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Santhera Announces Completion of First 6-Month Period of Pivotal VISION-DMD Trial with .
Santhera Pharmaceuticals Holding AGMarch 3, 2021 GMT Pratteln, Switzerland, March 3, 2021 – Santhera Pharmaceuticals (SIX: SANN) announces that the last patient has completed the last visit for the first period of the placebo-controlled pivotal VISION-DMD study with vamorolone in patients with Duchenne muscular dystrophy (DMD), conducted by partner ReveraGen Biopharma Inc. Subject to a positive 6-month topline data readout of this first study phase, this could allow for a regulatory submission to the US FDA in Q1-2022 with the potential to offer an alternative to current standard of care in DMD.
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Pivotal 6-month data readout for vamorolone in Duchenne muscular dystrophy (DMD) expected in the second quarter of 2021
Organization streamlined with a focus on cost savings and progressing vamorolone
Preliminary unaudited result for 2020: net sales CHF 15.0 million; net loss CHF 71.2 million; cash on hand as of December 31, 2020, CHF 12.4 million
Upsized financing from fund managed by Highbridge Capital Management, LLC (an existing investor in the Company), to satisfy liquidity needs through the next value-inflection point
Further strengthening of Santhera’s capital structure through a proposed convertible bond restructuring supported by its largest convertible bondholder representing approx. 32% of total bonds outstanding