Santhera Pharmaceuticals -- a Swiss biotech company -- had the U.S. approval its Duchenne muscular dystrophy drug pushed back to 2020 after the FDA said a second, successful phase III study would be required.
The company had hoped to persuade the FDA to accept an accelerated approval filing for Raxone based on a single, already completed phase III study -- but the FDA turned them down. Santhera shares fell 38% following the news.
Santhera is developing Raxone to improve the lung function of Duchenne patients.
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