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Correvio Pharma Corporation

Company NameCorrevio Pharma Corporation
Stock SymbolCORV
Class PeriodOctober 23, 2018 to December 05, 2019
Lead Plaintiff Motion DeadlineFebruary 10, 2020

On December 6, 2019, U.S. Food and Drug Administration (“FDA”) staffers who reviewed the Company’s resubmitted New Drug Application (“NDA”) for Brinavess found that the drug’s benefits did not offset its risks because Brinavess was associated with “serious liabilities” including irregular heartbeat, low blood pressure, and death.

On this news, Correvio’s share price fell $0.86 per share, or nearly 40%, to close at $1.30 per share on December 6, 2019, thereby injuring investors.

Then, on December 10, 2019, the FDA’s Cardiovascular and Renal Drugs Advisory Committee (“RDAC”) voted 11-2 against the resubmitted NDA, noting that the benefit-risk profile for Brinavess was inadequate to support approval.

On this news, Correvio’s share price further fell $0.94 per share, or more than 67%, to close at $0.46 per share on December 11, 2019, thereby injuring investors further.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors: (1) that the data supporting the Resubmitted New Drug Application ("NDA") for Brinavess did not minimize the significant health and safety issues observed in connection with the drug's original NDA; (2) that the foregoing substantially diminished the likelihood that the U.S. Food and Drug Administration would approve the Resubmitted NDA; and (3) that, as a result of the foregoing, the Company's financial statements were materially false and misleading at all relevant times.

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