NuPathe Inc. revealed the bad news before the stock market opened Tuesday: The launch of its migraine drug Zelrix will be delayed.
The Food and Drug Administration has issued a complete-response letter in connection with the Conshohocken company's first product, Zelrix. The letter means regulators have completed their review of NuPathe's new-drug application, but won't allow the FDA to approve the drug until certain questions are answered.
In a statement, NuPathe said the move means it won't launch Zelrix in the first half of 2012, as it had previously announced.
Here's what NuPathe CEO Jane Hollingsworth had to say: