FDA Grants Breakthrough Therapy Designation to Biogen's Salanersen for Spinal Muscular Atrophy
BIIB sits 62% above its 52-week low of $121.05.
Summary
The FDA has granted Breakthrough Therapy Designation to Biogen's investigational drug, salanersen, for Spinal Muscular Atrophy (SMA). This designation expedites the development and review process, signaling the FDA's belief that salanersen may offer substantial improvement over available therapies for this serious condition. This follows positive Phase 1b study results for salanersen announced in March, which showed clinically meaningful improvements in motor function. The news strengthens Biogen's presence in the SMA market, where it already markets Spinraza. Three global Phase 3 studies for salanersen are currently underway or recruiting.
At the time of this announcement, BIIB was trading at $195.96 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $28.9B. The 52-week trading range was $121.05 to $205.97. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.