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:
This CRL gives us confidence that we can provide the information needed to support FDA approval for our migraine patch in a timely manner.
However, investors appear to be lacking a little confidence. NuPathe shares, which had closed a $4.05 on Monday, were down by $1.44, to $2.61 in heavy afternoon trading involving 4.9 million shares.