Santhera Phramaceuticals falls 35% after DMD drug denial
Shares down 35% after news that Food and Drug Administration refuses to grant accelerated access
Updated : 15:28
Santhera Pharmaceuticals Holding shares plunged 35.09% in morning trading on Thursday after the Food and Drug Administration refused to allow the company accelerated approval for its Duchenne muscular dystrophy drug.
The decision means the company is forced to carry out another phase 3 trial which is likely take several years. The muscular disease currently has no available treatment.
The company originally hoped to persuade the FDA to accept an accelerated approval filing for Raxone based on a single, already completed phase 3 study. After meeting with Santhera, however, the FDA turned down the company's request.
The timetable to seek approval for Raxone will now be pushed back to 2020, with the results of a new study not expected to surface until 2019.
Raxone is a pill designed to stimulate mitochondria, the energy-producing organelle found inside cells. Santhera is developing Raxone to improve the lung function of Duchenne patients.