AbbVie is one of the worlds largest pharmaceutical companies. The companys revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVies future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humiras lost sales. Rinvoqan anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymeswas touted as one such drug. Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases. As is relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of RA, it required an additional safety trial to evaluate Xeljanzs risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanzs use could lead to serious heart-related issue, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the Class Period, Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks. However, investors began to learn the truth about Rinvoqs significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021, to close at $112.98 per share on June 25, 2021. Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq share[s] similar mechanisms of action with Xeljanz and may have similar risks as seen in the Xeljanz safety trial. The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021. After the Class Period, on December 3, 2021, AbbVie announced that the FDA had updated Rinvoqs label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed. On January 11, 2022, Defendants admitted that these changes to Rinvoqs label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoqs sales in 2025. The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the companys business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, Defendants statements about the companys business, operations, and prospects lacked a reasonable basis, As a result of the Defendants wrongful acts and omissions, and the significant decline in the market value of AbbVies securities, AbbVie investors have suffered significant damages.
The alleged class includes : All persons and entities who purchased or otherwise acquired AbbVie securities between April 30, 2021, through August 31, 2021, Inclusive.
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