Eiger BioPharmaceuticals, Inc.
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Northern District of California on behalf of those who acquired Eiger BioPharmaceuticals, Inc. (“Eiger”) (NASDAQ: EIGR) securities between March 10, 2021 through October 4, 2022 (the “Class Period”). Investors have until January 9, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Eiger is a commercial-stage biopharmaceutical company that focuses on the development and commercialization of targeted therapies for rare and ultra-rare diseases.
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, the price of Eiger shares declined by $2.51 per share, or approximately 29.36%, from $8.55 per share to close at $6.04 on September 6, 2022.
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, the price of Eiger shares declined by $0.37 per share, or approximately 5.01%, from $7.39 per share to close at $7.02 on October 5, 2022.
The lawsuit 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) as a result of all the foregoing, peginterferon lambda’s regulatory and commercial prospects for the treatment of COVID-19 were overstated.