Eiger Shares Fall After Plans Dropped for Covid-19 Treatment FDA Emergency Use Authorization
October 05 2022 - 9:09AM
Dow Jones News
By Sabela Ojea
Shares of Eiger BioPharmaceuticals Inc. fell 20% early Wednesday
after the company said that it won't submit a Food and Drug
Administration emergency use authorization application for a
Covid-19 treatment.
In premarket trading, the stock was at $5.89, down from its
close of $7.39 on Tuesday.
The biopharmaceutical company, which mainly develops and
commercializes therapies for the hepatitis delta virus, said that
the change in plans has been driven by feedback received from the
FDA on the use of the peginterferon lambda interferon in patients
with mild-to-moderate Covid-19.
The FDA concluded that any authorization request based on
Eiger's data was unlikely to meet the statutory criteria for
issuance of emergency use authorization in the current context of
the pandemic, the company said.
Eiger is now assessing which steps to take in the U.S., the
company said, adding that the FDA has asked it to consider
requesting an end-of-Phase 2 meeting to discuss a company-sponsored
pivotal trial that could support an eventual biologics license
application.
Write to Sabela Ojea at sabela.ojea@wsj.com
(END) Dow Jones Newswires
October 05, 2022 08:54 ET (12:54 GMT)
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