FDA anticipates giving its decision on BioMarin Pharmaceutical Inc's lead drug in early January
The deadline to decide on drug developer BioMarin Pharmaceutical Inc's lead drug has been pushed back by the U.S. Food and Drug Administration. The FDA hasn’t rejected it right away, keeping a ray of hope among shareholders.
The company made the announcement regarding the delay from the FDA on Friday, saying that the federal agency isn’t done with the drug review so far. The drug has been designed for the treatment of rare disorder Duchenne muscular dystrophy (DMD).
The FDA was to take a decision on the drug approval by December 27. The agency has anticipated that it will give its decision in early January.
The company’s shares have gone up by 4.3% to $105 prior to giving up some of its gains to trade up 3.2% at $103.84 during afternoon trading.
Wedbush Securities, Raymond James and Evercore ISI analysts have opined that the lack of an outright rejection could indicate an increased chance of the drug approval, based on FDA staff and a panel of outside experts’ strongly-worded review, made by them earlier.
Last month, the company’s data submitted on the basis of studies failed to persuade a panel of outside advisers to the FDA that the drug worked among DMD patients.
According to RBC Capital's Michael Yee, the delay is not going to alter the possibility that the drug would meet rejection. Yee said, “Fundamentally it does not materially change the consensus view on Wall Street that nearly fully expects an FDA rejection and institutional buy-side expectations are remarkably very low after a very cautious or concerned panel in November”.