EMA likely to reject Santhera's label expansion bid for Raxone

25 January 2018

Orphan mitochondrial and neuromuscular disease specialist Santhera Pharmaceuticals (SIX: SANN) suffered a 30% drop in share price yesterday on the back of a short press release trailing an anticipated negative opinion for Raxone (idebenone) from the European Medicines Agency.

The therapy is authorized in the European Union for the treatment of Leber's hereditary optic neuropathy. The firm is conducting the Phase III SIDEROS trial in patients with Duchenne muscular dystrophy in respiratory function decline.

While the company initially said it expected a decision on its label expansion in the first part of 2017, the due date was pushed back to late 2017 after the European regulator demanded more data.

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