Santhera announces restructuring as Puldysa hits the rocks
Swiss drugmaker Santhera Pharmaceuticals (SIX: SANN) lost more than 30% of its market value on Tuesday morning.
The company was forced to stop its Phase III SIDEROS study with Puldysa (idebenone) in patients with Duchenne muscular dystrophy (DMD) who are in respiratory decline and receive concomitant glucocorticoid treatment.
Data from an interim analysis conducted by the independent Data and Safety Monitoring Board (DSMB) concluded that the study was unlikely to meet its primary endpoint. As a consequence, Santhera will discontinue the trial, withdraw the European marketing authorization application and end the global development program for Puldysa.
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