ARTICLE | Company News
Santhera's rise continues with Fast Track in DMD
April 10, 2015 1:08 AM UTC
Santhera Pharmaceuticals Holding AG (SIX:SANN) gained CHF16.95 (18%) to CHF110.50 on Thursday after FDA granted Fast Track designation to Catena idebenone to treat Duchenne muscular dystrophy (DMD). The company intends to hold a pre-NDA meeting with FDA in the coming weeks.
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). ...