Sunday, August 2, 2015

NuPathe shares swoon after FDA delays OK for Zelrix

Federal regulators issued a Complete Response Letter to the Conshohocken drug developer for its migraine patch, meaning that Zelrix won't be launched during the first half of 2012.

NuPathe shares swoon after FDA delays OK for Zelrix

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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.

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About this blog
Mike Armstrong blogs about Philadelphia corporations and business-related topics. Contact him at 215-854-2980. Reach Mike at marmstrong@phillynews.com.

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