NEW YORK--(BUSINESS WIRE)--Bragar Eagel & Squire, P.C., a nationally recognized shareholder law firm, announces that a class action lawsuit has been filed in the United States District Court for the Southern District of New York on behalf of investors that purchased Correvio Pharma Corp. (NASDAQ: CORV) securities between October 23, 2018 and December 5, 2019 (the “Class Period”). Investors have until February 10, 2020 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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Correvio is a specialty pharmaceutical company that engages in developing therapeutics worldwide. The Company’s portfolio of marketed brands comprise, among others, vernakalant IV, or Brinavess, for the rapid conversion of recent onset atrial fibrillation (“AF”) to sinus rhythm.
Earlier during Brinavess’s development, safety concerns led the U.S. Food and Drug Administration (“FDA”) to decline approval for Brinavess.
On October 23, 2018, Correvio announced its intention to resubmit a New Drug Application (“NDA”) for Brinavess to the FDA for recent onset AF (the “Resubmitted NDA”), which followed additional purported safety data the Company had accumulated, as well as discussions with the FDA regarding the drug’s potential regulatory path forward. The Company later announced on July 25, 2019, that the FDA had accepted the Resubmitted NDA.
On December 6, 2019, FDA staffers reviewing Brinavess announced that they did not believe that the drug’s benefits outweighed its risks. Specifically, the FDA noted that Brinavess was associated with “serious liabilities” including low blood pressure, irregular heartbeats in the lower heart chambers, and death.
On this news, Correvio’s stock price fell $0.86 per share, or 39.81%, to close at $1.30 per share on December 6, 2019.
Then, on December 10, 2019, during pre-market hours, the Nasdaq Stock Market (“NASDAQ”) suspended trading in Correvio securities in anticipation of the FDA’s Cardiovascular and Renal Drugs Advisory Committee’s (“RDAC”) review and discussion of the Resubmitted NDA. Finally, just before market-close that day, the RDAC voted 11-2 against approval of the Resubmitted NDA, noting that Brinavess’s benefit-risk profile was not adequate to support approval.
On this news, and after Correvio shares resumed trading on the NASDAQ, Correvio’s stock price fell $0.94 per share, or 67%, to close at $0.46 per share on December 11, 2019.
The complaint, filed on December 12, 2019, alleges that throughout the Class Period defendants made false and/or misleading statements and/or failed to disclose that: (1) the data supporting the Resubmitted NDA for Brinavess did not minimize the significant health and safety issues observed in connection with the drug’s original NDA; (2) the foregoing substantially diminished the likelihood that the U.S. Food and Drug Administration would approve the Resubmitted NDA; and (3) as a result, Correvio’s public statements were materially false and misleading at all relevant times. When the true details entered the market, the lawsuit claims that investors suffered damages.
If you purchased Correvio securities during the Class Period and on an American exchange, have information, would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Brandon Walker or Melissa Fortunato by email at firstname.lastname@example.org, or telephone at (212) 355-4648, or by filling out this contact form. There is no cost or obligation to you.
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