While FDA approval may have come wrapped in a pretty box for shareholders, what is inside the box in terms of FDA warnings could be a huge problem for MannKind and Afrezza.
With large debt and a history of net losses, is it too little too late to turn around Dendreon?
For companies involved in the development of drugs, a PDUFA decision will meaningfully impact their stocks. With this in mind, there are several PDUFA decisions in upcoming months to watch for.
Anacor and Valeant are both developing new drugs for Onychomycosis. Can the both succeed in this niche market?
For many companies, FDA decisions represent the hallmark of years of investment. Due to the amount of time and money that was spent developing these drugs, they can also represent significant catalysts for investors.
For these three companies, trial results will make a big difference.
As Orexigen once again faces FDA approval, it appears as though the landscape for weight loss drugs may once again change.
After the release of phase 3 data, Osiris Pharmaceuticals has just changed the dynamics of the chronic diabetic foot ulcer market. Other companies will, of course, be affected by Osiris' clinical data.