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 in the second quarter of 2021. Throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, 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. 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.” Later that day, during after-market hours, on a call that Novavax hosted with investors and analysts to discuss the Company’s first quarter 2021 financial and operational results (the “1Q21 Investor Call”), Novavax confirmed that it was unlikely to seek an EUA for NVX-CoV2373 in the U.S. until July 2021 at the earliesti.e., the third quarter of 2021. Following publication of The Washington Post article, Novavax’s stock price fell $15.50 per share, or 8.81%, to close at $160.50 per share on May 10, 2021. Moreover, following the Company’s 1Q21 Investor Call, Novavax’s stock price continued to fall an additional $22.32 per share, or 13.91%, to close at $138.18 per share on May 11, 2021. Then, on August 5, 2021, 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 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, 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 fell $23.69 per share, or 14.76%, to close at $136.86 per share on October 20, 2021.
Notes:
The alleged class includes : All persons and entities other than Defendants that purchased or otherwise acquired Novavax securities between March 2, 2021 and October 19, 2021, both dates inclusive.
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