NRx is a clinical-stage small molecule pharmaceutical company that develops various therapeutics for the treatment of central nervous system disorders and life-threatening pulmonary diseases. The Company’s products include, among others, ZYESAMI, an investigational pre-commercial drug for COVID-19 related respiratory failure. In June 2021, NRx announced that it filed an application with U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for ZYESAMI (Aviptadil-acetate) to treat critically ill COVID-19 patients suffering with respiratory failure (the ZYESAMI EUA Application). The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) the ZYESAMI EUA Application contained insufficient data regarding the potential benefits and risks of ZYESAMI; (ii) accordingly, the FDA was unlikely to approve the ZYESAMI EUA Application in its present form; and (iii) as a result, the Company’s public statements were materially false and misleading at all relevant times. On November 4, 2021, NRx issued a press release announc[ing] that the [FDA] has declined to issue an [EUA] for ZYESAMI (aviptadil). The FDA stated that it was unable to issue the EUA at this time due to insufficient data regarding the known and potential benefits of the medicine and the known and potential risks of ZYESAMI in patients suffering from Critical COVID-19 with respiratory failure. On this news, NRxs stock price fell $2.27 per share, or 25.45%, to close at $6.65 per share on November 5, 2021.
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