What happened
Shares of Dermira (DERM), a biopharmaceutical company, jumped at the beginning of today's trading session in response to good news from the Food and Drug Administration. Investors looking forward to a shortened review for the company's experimental eczema therapy drove the stock 9.8% higher as of 12:10 p.m. EST on Tuesday.
So what
Impressive results from a midstage clinical trial persuaded the FDA to give Dermira's eczema candidate lebrikizumab a fast-track designation. Benefits that come with the designation include increased access with regulators before filing a new drug application and a shortened six-month review instead of the standard 10 months.
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Speeding up the development of lebrikizumab could make it a little easier to launch because a similar drug is already gaining popularity. Dupixent is another injectable that's producing blockbuster sales for collaboration partners Regeneron (REGN -1.11%) and Sanofi (SNY 5.90%), and competing with the pair won't be easy.
Now what
Dermira is relying heavily on lebrikizumab because its first product, Qbrexza, isn't exactly flying off the shelves. Sales of the treatment for excessive underarm sweating reached just $10.2 million in the third quarter. During the same period, developing lebrikizumab and launching Qbrexa drove operating expenses to $66.7 million.
It's going to be a long time before Dermira will get a chance to benefit from lebrikizumab's fast-track designation. The company began a pivotal study in October that isn't expected to produce results until the first half of 2021.
