Eiger: Peginterferon Lambda COVID-19 Emergency Use Authorization Application Delayed

 Eiger BioPharmaceuticals, Inc. (Nasdaq:EIGR), a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases, today provided an update on the status of its planned request for emergency use authorization (EUA) of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19 based on its most recent communications with the U.S. Food and Drug Administration (FDA).

Following a cooperative and extensive pre-EUA information exchange with FDA regarding the Phase 3 TOGETHER study of peginterferon lambda for COVID-19, the agency has indicated that it is not yet able to determine whether the criteria for the submission of an application and issuance of an EUA are likely to be met. FDA has indicated that it will consider any new information and data from the TOGETHER study to support an EUA as well as the company's plans for the further development of peginterferon lambda for COVID-19. Eiger remains in active dialogue with FDA and will provide additional information to the agency that the company believes could be supportive of an EUA.

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