NEW YORK, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Gainey McKenna & Egleston announces that a securities class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of all persons or entities who purchased Eiger BioPharmaceuticals ("Eiger" or "Company") EIGR between March 10, 2021 and October 4, 2022, both dates inclusive (the "Class Period").

Eiger's product candidates include, among others, peginterferon lambda. According to the Complaint, 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 Complaint alleges that throughout the Class Period defendants made false and/or misleading statements and/or failed to disclose that: (i) defendants overstated Eiger's clinical and regulatory drug development expertise; (ii) 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; (iii) 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; (iv) as a result, the FDA was unlikely to approve the submission of a peginterferon lambda EUA; and (v) consequently, peginterferon lambda's regulatory and commercial prospects for the treatment of COVID-19 were overstated.

On September 6, 2022, Eiger 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 by more than 29%.

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, Eiger 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 stock price fell an additional 5%, further damaging investors.

Investors who purchased or otherwise acquired shares of Enviva should contact the Firm prior to the January 9, 2023 lead plaintiff motion deadline. A lead plaintiff is a representative party acting on behalf of other class members in directing the litigation.  If you wish to discuss your rights or interests regarding this class action, please contact Thomas J. McKenna, Esq. or Gregory M. Egleston, Esq. of Gainey McKenna & Egleston at (212) 983-1300, or via e-mail at tjmckenna@gme-law.com or gegleston@gme-law.com.

Please visit our website at http://www.gme-law.com for more information about the firm.