RM LAW, P.C. announces that a class action lawsuit has been filed on behalf of all persons or entities that purchased Eiger Biopharmaceuticals, Inc. ("Eiger" or the "Company") (NASDAQ: EIGR) securities during the period from March 10, 2021 through October 4, 2022, inclusive (the “Class Period”).
Eiger shareholders may, no later than January 9, 2023, move the Court for appointment as a lead plaintiff of the Class. If you purchased shares of Eiger and would like to learn more about these claims or if you wish to discuss these matters and have any questions concerning this announcement or your rights, contact Richard A. Maniskas, Esquire toll-free at (844) 291-9299 or to sign up online, click here.
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.
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.”
If you are a member of the class, you may, no later than January 9, 2023, request that the Court appoint you as lead plaintiff of the class. A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member's claim is typical of the claims of other class members, and that the class member will adequately represent the class. Under certain circumstances, one or more class members may together serve as "lead plaintiff." Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. You may retain RM LAW, P.C. or other counsel of your choice, to serve as your counsel in this action.