The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the District of Maryland on behalf of those who acquired Novavax, Inc. (“Novavax” or the “Company”) (NASDAQ: NVAX) securities from March 2, 2021 through October 19, 2021, inclusive (the “Class Period”). Investors have until January 11, 2022 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
Novavax is a biotechnology company that focuses on the discovery, development, and commercialization of vaccines to prevent serious infectious diseases and address health needs. The Company’s product candidates include, among others, 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.
On May 10, 2021, 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 [C]ompany’s plans.” On this news, Novavax’s stock price declined by $15.50 per share, or approximately 8.8%, from $176.00 per share to close at $160.50 per share on May 10, 2021.
Later that day, after the markets closed, on the Company’s 1Q21 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. On this news, Novavax’s stock price declined by $22.32 per share, or approximately 13.9%, from $160.50 per share to close at $138.18 per share on May 11, 2021.
On August 5, 2021, after the markets closed, Novavax issued a press release reporting its financial results and operational highlights for the second quarter of 2021. Among other news, Novavax reported that it expected to file for NVX-CoV2373’s EUA in the fourth quarter of 2021, rather than the third quarter of 2021. On this news, Novavax’s stock price declined by $46.31 per share, or approximately 19.6%, from $236.20 per share to close at $189.89 per share on August 6, 2021.
On October 19, 2021, after the markets closed, Politico published an article entitled “‘They rushed the process’: Vaccine maker’s woes hamper global inoculation campaign.” The Politico article reported, in relevant part, 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 the Company could take until the end of 2022 to resolve its manufacturing issues and win regulatory authorizations and approvals. On this news, Novavax’s stock price declined by $23.69 per share, or approximately 14.8%, from $160.55 per share to close at $136.86 per share on October 20, 2021.
The lawsuit alleges throughout the Class Period, 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, the Company overstated the regulatory and commercial prospects for NVX-CoV2373; and (iv) as a result, the Company’s public statements were materially false and misleading at all relevant times.