Novavax 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 January 11, 2022 move the Court to serve as lead plaintiff of the class, if you so choose.
A class action lawsuit has been filed on behalf of those who purchased or acquired Novavax, Inc. (“Novavax”) (NASDAQ: NVAX) securities between March 2, 2021 and October 19, 2021, both dates inclusive (the “Class Period”).
Novavax is a biotechnology company that focuses on the discovery, development, and commercialization of vaccines to prevent serious infectious diseases and address health needs. Its product candidates include NVX-CoV2373, which is in development as a vaccine for COVID-19. Prior to the start of the Class Period, Novavax announced that it planned to complete Emergency Use Authorization (“EUA”) submissions for NVX-CoV2373 with the U.S. Food and Drug Administration (“FDA”) in the second quarter of 2021.
The Class Period commences on March 2, 2021, the day after Novavax issued a press release, during after-market hours, announcing its fourth quarter and full year 2020 financial results and operational highlights. The press release stated, in relevant part, that: (1) Novavax “[e]ngaged in ongoing dialogue with [the FDA] . . . with potential for EUA filing in the second quarter of 2021”; (2) Novavax “[i]ncreased projected global manufacturing capacity to over 2 billion annualized doses when at full-capacity, expected to occur in mid-2021”; (3) Novavax “[c]ompleted collaborations for global manufacturing, commercialization and distribution of NVX-CoV2373”; and (4) Novavax “[s]ecured agreements for approximately 200 million doses of NVX-CoV2373.”
The truth began to emerge on May 10, 2021, when The Washington Post reported that Novavax’s EUA “filing was delayed by manufacturing regulatory issues, until June at the earliest, according to four people who had recently been briefed on the company’s plans.” Specifically, The Washington Post reported that “[t]he delay is due in part to a regulatory manufacturing issue related to an assay,” according to the people briefed on the trial status, which “are tests used throughout the manufacturing process to check the contents and quality of vaccines.” Later that day, during after-market hours, on Novavax’s first quarter 2021 investor call, Novavax confirmed that it was unlikely to seek EUA for NVX-CoV2373 in the U.S. until July 2021 at the earliest—i.e., the third quarter of 2021. Following this news, Novavax’s stock price fell $15.50 per share, or 8.81%, to close at $160.50 per share on May 10, 2021.
Then, on August 5, 2021, Novavax issued a press release reporting its second quarter 2021 financial results and operational highlights. Among other news, Novavax reported that it “[e]xpect[s] to submit for [EUA] to the [FDA for NVX-CoV2373] in the fourth quarter of 2021[,]” rather than the third quarter of 2021. Following this news, Novavax’s stock price fell $46.31 per share, or 19.61%, to close at $189.89 per share on August 6, 2021.
Finally, on October 19, 2021, Politico published an article entitled “‘They rushed the process’: Vaccine maker’s woes hamper global inoculation campaign.” The Politico article reported that Novavax “faces significant hurdles in proving it can manufacture a shot that meets regulators’ quality standards” with respect to NVX-CoV2373. The Politico article cited anonymous sources as stating that Novavax’s “issues are more concerning than previously understood” and that Novovax could take until the end of 2022 to resolve its manufacturing issues and win regulatory authorizations and approvals. Following this news, Novavax’s stock price fell $23.69 per share, or 14.76%, to close at $136.86 per share on October 20, 2021.
The complaint alleges that throughout the Class Period, the defendants made false and/or misleading statements and/or failed to disclose that: (i) Novavax overstated its manufacturing capabilities and downplayed manufacturing issues that would impact its approval timeline for NVX-CoV2373; (ii) as a result, Novavax was unlikely to meet its anticipated EUA regulatory timelines for NVX-CoV2373; (iii) accordingly, Novavax overstated the regulatory and commercial prospects for NVX-CoV2373; and (iv) as a result, Novavax’s public statements were materially false and misleading at all relevant times.
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: James Maro, Esq. (484) 270-1453; toll-free at (844) 887-9500; or via e-mail at info@ktmc.com. 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.