Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, reminds investors that a class action lawsuit has been filed against Eiger Biopharmaceuticals, Inc. (“Eiger” or the “Company”) (NASDAQ: EIGR) in the United States District Court of Northern California on behalf of all persons and entities who purchased or otherwise acquired Eiger securities between March 10, 2021 and October 4, 2022, both dates inclusive (the “Class Period”). Investors have until January 9, 2023 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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On September 6, 2022, during pre-market hours, Eiger issued a press release (the “September 2022 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 September 2022 Press Release stated, in relevant part, that “[f]ollowing 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.”
On this news, Eiger’s stock price fell $2.51 per share, or 29.36%, to close at $6.04 per share on September 6, 2022. Despite this decline in the Company’s stock price, Eiger securities continued to trade at artificially inflated prices throughout the remainder of the Class Period because of Defendants’ continued misstatements and omissions regarding the TOGETHER study and peginterferon lambda’s regulatory and commercial prospects as a treatment for COVID-19.
For example, the September 2022 Press Release represented that “Eiger remains in active dialogue with [the] FDA and will provide additional information to the agency that the company believes could be supportive of an EUA.”
Likewise, the September 2022 Press Release advised investors that “[t]he company has recently generated new data and analyses from the TOGETHER study that it plans to discuss with FDA, including further statistical modeling and efficacy analyses of the study’s primary and secondary endpoints in patients treated within three days of symptom onset”; that “[t]he endpoint of hospitalization due to COVID-19 and all-cause mortality for patients treated within three days of symptom onset is consistent with the endpoint used to authorize other therapeutics for emergency use”; and that “Eiger plans to provide new additional analyses of long-term follow-up data, including rates of rebound and incidence of long COVID, as well as an indirect comparative analysis of mortality and hospitalizations in vaccinated patients when treated with peginterferon lambda compared to other therapeutics authorized for emergency use.”
The September 2022 Press Release also quoted Defendant Cory, who assured investors that Defendants “remain committed to continued engagement with the [FDA] to obtain the necessary alignment to submit our EUA application for peginterferon lambda,” and that “[g]iven its unique mechanism of action and the ongoing need for effective COVID-19 therapeutics, making peginterferon lambda available for patients remains a priority for Eiger.”
The statements referenced in ¶¶ 42-46 were materially false and misleading because Defendants made false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and compliance policies. Specifically, 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; (v) as a result of all the foregoing, peginterferon lambda’s regulatory and commercial prospects for the treatment of COVID-19 were overstated; and (vi) as a result, the Company’s public statements were materially false and misleading at all relevant times.
On October 5, 2022, during pre-market hours, Eiger announced that it would not seek an EUA application for peginterferon lambda, stating, in relevant part:
[F]ollowing feedback from the [FDA], the company will not submit an [EUA] application of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19.
Following Eiger’s press release on September 6, 2022, the company submitted a pre-EUA meeting request to [the] FDA, as well as additional morbidity and mortality outcomes data and analyses from the investigator-sponsored TOGETHER study. This included further statistical modeling and efficacy analyses of the study's primary and secondary endpoints and long-term follow-up data that the company believes continue to support the initial positive topline outcomes reported in March. In response, [the] FDA denied the request for a pre-EUA meeting. Citing its concerns about the conduct of the TOGETHER study, [the] FDA concluded that any authorization request based on these data is unlikely to meet the statutory criteria for issuance of an EUA in the current context of the pandemic.
On this news, Eiger’s stock price fell $0.37 per share, or 5.01%, to close at $7.02 per share on October 5, 2022.
As a result of Defendants’ wrongful acts and omissions, and the precipitous decline in the market value of the Company’s securities, Plaintiff and other Class members have suffered significant losses and damages.
If you purchased or otherwise acquired Eiger shares and suffered a loss, are a long-term stockholder, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Melissa Fortunato by email at email@example.com, telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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Bragar Eagel & Squire, P.C.
Brandon Walker, Esq.
Melissa Fortunato, Esq.