Companies in the pharmaceutical industry are generally involved in the lengthy process of getting their drug candidates to market through clinical trials. There is a fair amount of risk involved, as with biotech companies, should a study come back negative or should a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be big upside. U.S. Food and Drug Administration (FDA) rulings can make or break these companies. A single failed clinical trial can mean disaster for a stock.
24/7 Wall St. has collected five big FDA decisions coming up in March and added some color, along with the trading range and price target. Note that, due to many outside and internal factors, there are no assurances that the dates will not change.
As a side note about the Prescription Drug User Fee Act (PDUFA): a Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.
Opko Health
Opko Health Inc. (NYSE: OPK) announced that the FDA had accepted its New Drug Application (NDA) for Rayaldee for full review and set a PDUFA target date of March 29. As previously reported, this NDA is supported by data from two randomized, double-blind, placebo-controlled studies and one open-label extension study conducted in the targeted patient population at a total of 105 U.S. sites. These studies met all primary efficacy and safety endpoints.
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