NEW YORK, Nov. 09, 2022 (GLOBE NEWSWIRE) — Gainey McKenna & Egleston announce that it has filed a securities class action in the United States District Court for the Northern District of California on behalf of all individuals or entities that purchased Eiger became BioPharmaceuticals (“Eiger” or “Company”) (NYSE: EIGR) between March 10, 2021 and October 4, 2022, both dates inclusive (the “Class Period”).

Eiger’s product candidates include peginterferon lambda. According to the Complaint, based on the results of the TOGETHER study, Eiger announced in March 2022 that it would submit an application to the U.S. Food and Drug Administration (“FDA”) for an Emergency Use Authorization (“EUA “)) for Peginterferon Lambda the treatment of patients with mild to moderate COVID-19.

The Complaint alleges that during the Class Period, the Defendants made false and/or misleading statements and/or failed to disclose the following: (i) the Defendants overvalued Eiger’s clinical and regulatory drug development expertise; (ii) the Defendants failed to properly evaluate and/or ignored issues with the TOGETHER study design 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 peginterferon lambda EUA in the current context of the pandemic; (iv) as a result, it was unlikely that the FDA would approve the filing of a peginterferon lambda EUA; and (v) consequently, the regulatory and commercial prospects of peginterferon lambda for the treatment of COVID-19 have been overstated.

On September 6, 2022, Eiger announced that “[f]After a cooperative and extensive exchange of information in front of the EEA with [the] Regarding the Phase 3 TOGETHER study of peginterferon lambda for COVID-19, the FDA has advised the agency that it is not yet in a position to determine whether the criteria for filing an application and issuance of an EUA are likely to be met .” On this…