Biogen’s third quarter earnings report isn’t looking good these days, putting an uneasy cloud over the biotech sector as a whole. But there is a light at the end of the tunnel and it’s being cast by Alexion Pharmaceuticals (ALXN).
This approval by the FDA is a triumph for CEO of ALXB, Ludwig Hantson. Over the past year, the company has gone under new management and turned over a new leaf.
“While we expected a positive outcome for this event, the approval timing and announcement were definitely unusual for what seemed to us to be a relatively straightforward sBLA. The announcement and label should be well received by investors.”
However, this decision by the FDA comes with skepticism in other areas.
Because Soliris is known to be one of the most expensive drug therapies in the world, critics argue that this could create a sense of pushback from insurance companies. More skepticism emerges because the agency allowed this approval because of information from a trial that was late in the game. In it, Soliris narrowly missed the primary endpoint. According to Cowen analyst Eric Schmidt, when it came to Soliris’s label, the FDA okay’d another analysis that allowed the trial to achieve statistical significance. A number of secondary endpoints were a success, in addition to that.
Relief rally is expected in the stock market and though it’s not a massive one, at $137.63, the shares are up 1.8% in recent market action.
