Eiger Shares Fall After Plans Dropped for Covid-19 Treatment FDA Emergency Use Authorization

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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