Eiger BioPharmaceuticals, Inc.

In March 2022, Eiger announced that it would submit an Emergency Use Authorization (“EUA”) request to the U.S. Food and Drug Administration (“FDA”) for its mild-to-moderate COVID-19 drug, peginterferon lambda, based on the results of the independent, multi-center TOGETHER study.

On September 6, 2022, Eiger provided an update on the status of its planned request for EUA, disclosing that “[f]ollowing a cooperative and extensive pre-EUA information exchange with [the] FDA . . . 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.”

On this news, Eiger’s stock price fell $2.51, or 29.4%, to close at $6.04 per share on September 6, 2022, thereby injuring investors.

Then, on October 5, 2022, Eiger announced that it would no longer be seeking an EUA request after the FDA had “denied the request for a pre-EUA meeting.” The Company disclosed that the FDA “concluded that any authorization request based on the data [presented] is unlikely to meet the statutory criteria for issuance of an EUA in the current context of the pandemic.”

On this news, Eiger’s stock price fell $0.37, or 5%, to close to $7.02 per share on October 5, 2022, further injuring investors.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) Defendants overstated Eiger’s clinical and regulatory drug development expertise; (2) Defendants failed to properly assess, and/or ignored issues with, the design of the TOGETHER study and its ability to support the peginterferon lambda EUA; (3) there were issues with the conduct of the TOGETHER study and/or the TOGETHER study was not properly designed for the peginterferon lambda EUA in the current context of the pandemic; (4) as a result, the FDA was unlikely to approve the submission of a peginterferon lambda EUA; (5) as a result of all the foregoing, peginterferon lambda’s regulatory and commercial prospects for the treatment of COVID-19 were overstated; and (6) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.