EuroBiotech: More Articles of Note

EuroBiotechReportEuroBiotech: More Articles of Note

http://www.fiercebiotech.com/story/eurobiotech-more-articles-note/2015-04-09

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Santhera Pharmaceuticals (SIX:SANN) picked up a fast-track designation from FDA for its Duchenne muscular dystrophy drug, Catena. Phase III data on the treatment–which is known as Raxone in Europe–is currently being prepared for a new drug application. Santhera expects to meet with the FDA to discuss the filing in the coming weeks. The stock traded up 11% following the news. Release

Santhera’s rise continues with Fast Track in DMD

BIOCENTURY

Santhera’s rise continues with Fast Track in DMD

Thursday, April 9, 2015

http://www.biocentury.com/dailynews/company/2015-04-09/santheras-rise-continues-with-fast-track-in-dmd

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Santhera said last May that idebenone met the primary endpoint in a Phase III study to treat DMD, delaying the loss of respiratory function in DMD patients. Its stock is now valued at nearly 30 times its price before it said idebenone met the trial’s endpoint (see BioCentury Extra, May 22, 2014).

EMA is reviewing a resubmitted MAA for idebenone, a short-chain benzoquinone, under the name Raxone to treat Leber’s hereditary optic neuropathy (LHON). Santhera expects a decision in 1H15