January 26, 2021 - An investor in shares of AstraZeneca PLC (NASDAQ: AZN) filed a lawsuit in the U.S. District Court for the Southern District of New York over alleged violations of Federal Securities Laws by AstraZeneca PLC in connection with certain allegedly false and misleading statements made between May 21, 2020 and November 20, 2020.
AstraZeneca PLC was one of the early front-runners in the race to develop a COVID-19 vaccine.
In April 2020, AstraZeneca PLC partnered with Oxford University to develop a potential recombinant adenovirus vaccine for the virus, later dubbed AZD1222.
On November 23, 2020, AstraZeneca PLC announced the results of an interim analysis of its ongoing trial for AZD1222. The announcement immediately began to raise questions among analysts and industry experts. AstraZeneca PLC disclosed that the interim analysis involved two smaller scale trials in disparate locales (the United Kingdom and Brazil) that, for unexplained reasons, employed two different dosing regimens. One clinical trial provided patients a half dose of AZD1222 followed by a full dose, while the other trial provided two full doses. Counterintuitively, AstraZeneca PLC claimed that the half dosing regimen was substantially more effective at preventing COVID-19 at 90% efficacy than the full dosing regimen, which had achieved just 62% efficacy.
In the days that followed, additional revelations were made regarding problems with AstraZeneca’s AZD1222 clinical trials. For example, the differing dosing regimens were revealed to be due to a manufacturing error rather than trial design. Also, the half-strength dose had not been tested in people over the age of 55 – despite the fact that this population was the most vulnerable to COVID-19. Moreover, certain trial participants received their second dose later than originally planned. U.S. regulators 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 United States.
Shares of AstraZeneca PLC (NASDAQ: AZN) declined from $58.08 per share on November 11, 2020, to as low as $48.17 per share on December 24, 2020.
According to the complaint the plaintiff alleges on behalf of purchasers of AstraZeneca PLC (NASDAQ: AZN) common shares between May 21, 2020 and November 20, 2020, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that between May 21, 2020 and November 20, 2020, the defendants misrepresented facts regarding the Company’s ongoing AZD1222 clinical trials and concealed problems that had arisen in the trials, including a dosing error which had been discovered early on by the Company but not disclosed to investors.