Eiger Biopharmaceuticals, Inc.

Eiger Biopharmaceuticals, Inc. Misled Shareholders Regarding the Viability of its Product Candidate Designed to Treat COVID-19

A shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired Eiger Biopharmaceuticals, Inc. (NASDAQ: EIGR) securities between March 10, 2021 and October 4, 2022, for violations of the Securities Exchange Act of 1934. Eiger is a commercial-stage biopharmaceutical company that focuses on the development and commercialization of targeted therapies for rare and ultra-rare diseases.

According to the complaint, Eiger’s product candidates include peginterferon lambda, which is being evaluated for the treatment of COVID-19 in the TOGETHER study – a Phase 3 study evaluating multiple therapies in newly diagnosed, high-risk, non-hospitalized patients with mild-to-moderate COVID-19. In March 2022, based on the results of the TOGETHER study, Eiger announced that it would submit an Emergency Use Authorization (“EUA”) request to the U.S. Food and Drug Administration (“FDA”) for peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19 (the “peginterferon lambda EUA”).

During the class period, defendants failed to disclose that defendants overstated Eiger’s clinical and regulatory drug development expertise and did not properly assess, and/or ignored issues with, the design of the TOGETHER study and its ability to support the peginterferon lambda EUA. Defendants also failed to disclose that there were issues with the conduct of the TOGETHER study and/or the TOGETHER study was improperly designed for the peginterferon lambda EUA in the current context of the pandemic. As a result, the FDA was unlikely to approve the submission of a peginterferon lambda EUA rendering peginterferon lambda’s regulatory and commercial prospects for the treatment of COVID-19 to be overstated.

On September 6, 2022, Eiger issued a press release “provid[ing] an update on the status of its planned request for [EUA] of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19 based on its most recent communications with the [FDA].”  Specifically, the Company announced that “[f]ollowing a cooperative and extensive pre-EUA information exchange with [the] 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.” On this news, Eiger’s stock price fell $2.51 per share, or 29.36%, to close at $6.04 per share on September 6, 2022.

Then, on October 5, 2022, Eiger announced that it would not seek an EUA request for peginterferon lambda after the FDA had “denied the request for a pre-EUA meeting.” Specifically, the Company disclosed that, “[c]iting its concerns about the conduct of the TOGETHER study, [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 per share, or 5.01%, to close at $7.02 per share on October 5, 2022.


 

What Now: Shareholders who purchased shares of Eiger Biopharmaceuticals, Inc. securities between March 10, 2021 and October 4, 2022, must file their papers to be appointed lead plaintiff for the class by January 9, 2023. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.  You do not have to participate in the case to be eligible for a recovery.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.

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