||United States District Court for the Northern District of Illinois
||The Honorable Harry Daniel Leinenweber
||April 30, 2021 - August 31, 2021
AbbVie investors may receive additional information about the case by clicking the link "Submit Your Information" above. If you are a member of the class described below, you may no later than June 6, 2022 move the Court to serve as lead plaintiff of the class, if you so choose.
Kessler Topaz Meltzer & Check, LLP has filed a class action lawsuit on behalf of those who purchased or acquired AbbVie, Inc. (“AbbVie”) (NYSE: ABBV) securities between April 30, 2021 and August 31, 2021, inclusive (the “Class Period”).
AbbVie is one of the world’s largest pharmaceutical companies. The company’s revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVie’s future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humira’s lost sales. Rinvoq—an anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes—was 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 Xeljanz’s risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz’s 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 Rinvoq’s 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 Rinvoq’s 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 Rinvoq’s label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq’s sales in 2025.
The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the company’s 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 company’s 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 AbbVie’s securities, AbbVie investors have suffered significant damages.
A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case. Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.
If you wish to discuss this action or have any questions concerning this notice or your rights or interests with respect to these matters, please contact Kessler Topaz Meltzer & Check, LLP: Jon Naji, Esq. (484) 270-1453 or via e-mail at firstname.lastname@example.org. If you would like additional information about the suit, please click on the link "Submit Your Information" above and fill out the form as promptly as possible.