A lawsuit was filed on behalf of investors in Eiger BioPharmaceuticals, Inc. (NASDAQ:EIGR) shares over alleged securities laws violations. Deadline: January 9, 2023. NASDAQ:EIGR investors should contact the Shareholders Foundation.
San Diego, CA -- (SBWIRE) -- 11/30/2022 -- An investor, who purchased shares of Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR), filed a lawsuit against Eiger BioPharmaceuticals, Inc over alleged violations of Federal Securities Laws.
Investors who purchased shares of Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR) have certain options and for certain investors are short and strict deadlines running. Deadline: January 9, 2023. NASDAQ: EIGR investors should contact the Shareholders Foundation at firstname.lastname@example.org or call +1(858) 779 - 1554.
Palo Alto, CA based Eiger BioPharmaceuticals, Inc., a commercial-stage biopharmaceutical company, focuses on the development and commercialization of targeted therapies for rare and ultra-rare diseases in the United States and internationally.
Eiger BioPharmaceuticals' product candidates include, among others, peginterferon lambda. Peginterferon lambda is being evaluated for, inter alia, the treatment of COVID-19 in the TOGETHER study, which is an independent multi-center, investigator-sponsored, randomized, placebo-controlled adaptive platform Phase 3 study evaluating multiple therapeutics in newly diagnosed, high-risk, non-hospitalized patients with mild-to-moderate COVID-19. Peginterferon lambda was added to the TOGETHER study in May 2021.
In March 2022, based on the results of the TOGETHER study, Eiger BioPharmaceuticals, Inc 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").
On September 6, 2022, Eiger BioPharmaceuticals, Inc. provided an update on the status of its planned request for emergency use authorization (EUA) of peginterferon lambda. Following a cooperative and extensive pre-EUA information exchange with 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. FDA has indicated that it will consider any new information and data from the TOGETHER study to support a EUA as well as the company's plans for the further development of peginterferon lambda for COVID-19. Eiger BioPharmaceuticals, Inc. said that it remains in active dialogue with FDA and will provide additional information to the agency that the company believes could be supportive of a EUA.
Shares of Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR) declined from $9.89 per share on August 16, 2022, to as low as $5.84 per share on September 06, 2022.
Then, on October 5, 2022, Eiger BioPharmaceuticals, Inc 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."
Shares of Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR) declined to as low as $3.96 per share on November 09, 2022.
The plaintiff claims that between March 10, 2021 and October 4, 2022, the Defendants made false and/or misleading statements and/or failed to disclose that Defendants overstated Eiger's clinical and regulatory drug development expertise, that 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,that 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, that as a result, the FDA was unlikely to approve the submission of a peginterferon lambda EUA, that as a result of all the foregoing, peginterferon lambda's regulatory and commercial prospects for the treatment of COVID-19 were overstated, and that as a result, the Company's public statements were materially false and misleading at all relevant times.
Those who purchased shares of Eiger BioPharmaceuticals, Inc. (NASDAQ: EIGR) have certain options and should contact the Shareholders Foundation.
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