Reveragen BioPharma, Inc.
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In a major boost for Santhera and Duchenne muscular dystrophy patients, EU regulators have backed the firm’s Agamree for children aged four years and older and a launch in Germany is scheduled for January.
The Swiss rare diseases firm Santhera has signed a licensing deal for its Duchenne muscular dystrophy drug vamorolone, which could be launched in both the US and the EU by the end of the year, paying off short-term debt and cleaning up the balance sheet.
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The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
The Swiss biotech is hoping that its Duchenne muscular dystrophy prospect, vamorolone, will get on the FDA fast track to approval but acknowledges that getting more funds is an urgent priority to prepare for a potential US launch.
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