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NEW YORK, NY / ACCESSWIRE / February 20, 2021 / Pomerantz LLP announces that a class action lawsuit has been filed against AstraZeneca plc ("AstraZeneca" or the "Company") (NASDAQ:AZN) and certain of its officers. The class action, filed in the United States District Court for the Southern District of New York, and docketed under 21-cv-00825, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise, acquired AstraZeneca securities between May 21, 2020 and November 20, 2020, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased AstraZeneca securities during the Class Period, you have until March 27, 2021 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at email@example.com or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
AstraZeneca is one of the largest biopharmaceutical companies in the world. The Company is primarily known for its development of drugs to treat cancer, asthma, and other chronic conditions, and has not historically specialized in vaccine development.
In April 2020, the Company partnered with Oxford University to develop a potential recombinant adenovirus vaccine for COVID-19, later dubbed AZD1222. Oxford University's work on developing a COVID-19 vaccine began in January 2020, almost as soon as the virus was recognized globally. Volunteers for the first clinical trial were recruited and screened in March 2020, and a Phase 1 clinical trial was launched the following month.
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements, and failed to disclose material adverse facts about the Company's business, operational, and compliance policies. Specifically, Defendants made false and/or misleading statements and failed to disclose to investors that: (i) initial clinical trials for AZD1222 had suffered from a critical manufacturing error, resulting in a substantial number of trial participants receiving half the designed dosage; (ii) clinical trials for AZD1222 consisted of a patchwork of disparate patient subgroups, each with subtly different treatments, undermining the validity and import of the conclusions that could be drawn from the clinical data across these disparate patient populations; (iii) certain clinical trial participants for AZD1222 had not received a second dose at the designated time points, but rather received the second dose up to several weeks after the dose had been scheduled to be delivered according to the original trial design; (iv) AstraZeneca had failed to include a substantial number of patients over 55 years of age in its clinical trials for AZD1222, despite this patient population being particularly vulnerable to the effects of COVID-19 and thus a high priority target market for the drug; (v) AstraZeneca's clinical trials for AZD1222 had been hamstrung by widespread flaws in design, errors in execution, and a failure to properly coordinate and communicate with regulatory authorities and the general public; (vi) as a result of all the foregoing, the clinical trials for AZD1222 had not been conducted in accordance with industry best practices and acceptable standards and the data and conclusions that could be derived from the clinical trials was of limited utility; (vii) as a result of all the foregoing, AZD1222 was unlikely to be approved for commercial use in the U.S. in the short term, one of the largest potential markets for the drug; and (viii) as a result, the Company's public statements were materially false and misleading at all relevant times.
On November 23, 2020, AstraZeneca issued a release announcing the results of an interim analysis of its ongoing trial for AZD1222. Although the release claimed that the drug candidate had met its primary efficacy endpoints, the announcement immediately began to raise questions among analysts and industry experts. AstraZeneca disclosed that the interim analysis involved two smaller scale trials in disparate locales-the United Kingdom ("U.K.") and Brazil-that, for unexplained reasons, employed two different dosing regimens.
On this news, AstraZeneca's American Depository Share ("ADS") price fell nearly $2.00 per share during the trading day on November 23, 2020, on extremely high trading volume of over 13 million ADSs traded.
To limit the fallout, AstraZeneca hastily put out statements defending its interim analysis and held conference calls with analysts covering the Company. However, the Company's responses raised more questions than answers and cast further doubt on the integrity of the trials' design, data, and conclusions. Most shockingly, AstraZeneca revealed that the half dosing regimen was not a part of the original trial design, but rather was forced upon the Company because of a manufacturing error discovered early in the trial process. Specifically, AstraZeneca discovered that a manufacturer had underpredicted the dose of the vaccine by half in the U.K. trial.
Additional damaging revelations came to light. For example, Dr. Moncef Slaoui, the head of Operation Warp Speed, told reporters that the half-strength dose had not been initially tested in people over the age of 55, even though this population was the most vulnerable to COVID-19. He also stated that if AstraZeneca could not clearly explain the discrepancies in its trial results, the results would most likely "not be sufficient for approval" for commercial sale in the U.S. Moreover, certain trial participants received their second dose weeks later than originally planned. The trials also amalgamated a "bewildering array" of experimental groups and subgroups, each receiving subtly different treatments, and inexplicably excluded certain subgroups from the reported interim analysis. AstraZeneca further failed to timely provide data and information to the U.S. Food and Drug Administration ("FDA") after the emergence of neurological symptoms in two clinical trial participants earlier in the year, which had resulted in a temporary halt to U.S. clinical trials.
Analysts and reporters widely criticized the faulty trial design and failure of AstraZeneca to be forthright with the public and investors, describing AstraZeneca's interim results as a "mess," riddled with "irregularities and omissions," and the product of "cherry-picked . . . data" and "very shaky science." For example, on November 25, 2020, Wired issued a comprehensive report on AstraZeneca's botched trial results entitled "The AstraZeneca Covid Vaccine Data Isn't Up to Snuff."
As negative news reports continued to reveal previously undisclosed problems and flaws in AstraZeneca's clinical trials for AZD1222, AstraZeneca's ADS price fell to $52.60 per share by market close on November 25, 2020, a 5% decline over three trading days in response to adverse news on abnormally high trading volume.
The Pomerantz Firm, with offices in New York, Chicago, Los Angeles, and Paris is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.
SOURCE: Pomerantz LLP
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