Eiger BioPharmaceuticals, Inc.
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Eiger BioPharmaceuticals’ product candidates include, among others, peginterferon lambda. In March 2022, based on the results of the TOGETHER study, Eiger BioPharmaceuticals 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 Eiger BioPharmaceuticals class action lawsuit alleges that throughout the Class Period defendants made false and/or misleading statements and/or failed to disclose that: (i) defendants overstated Eiger BioPharmaceuticals’ 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 BioPharmaceuticals 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 BioPharmaceuticals’ stock price fell by more than 29%.
Then, on October 5, 2022, Eiger BioPharmaceuticals 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 BioPharmaceuticals 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 BioPharmaceuticals’ stock price fell an additional 5%, further damaging investors.