NEW YORK, Jan. 18, 2020 /PRNewswire/ -- Pomerantz LLP announce that a class action lawsuit has been filed against Correvio Pharma Corporation ("Correvio" or the "Company") (NASDAQ: CORV) and certain of its officers. The class action, filed in United States District Court, for the Southern District of New York, and docketed under 19-cv-11361, is on behalf of a class consisting of investors who purchased or otherwise acquired Correvio securities between October 23, 2018 and December 5, 2019, both dates inclusive (the "Class Period"), seeking to recover damages caused by Defendants' violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the "Exchange Act") and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased Correvio securities during the class period, you have until February 10, 2020 to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and number of shares purchased.
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 after a patient with no apparent heart issues had died after being administered the drug during one of its clinical trials. The FDA then mandated a clinical hold on the Brinavess program, which remains in effect in the U.S. Correvio's SEC filings would later characterize the patient death that precipitated the clinical hold as "a single unexpected serious adverse event of cardiogenic shock experienced by a patient with AF who received vernakalant (IV)."
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.
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company's business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) 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; (ii) the foregoing substantially diminished the likelihood that the FDA would approve the Resubmitted NDA; and (iii) as a result, the Company's public statements were materially false and misleading at all relevant times.
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.
Following 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, damaging investors.
The Pomerantz Firm, with offices in New York, Chicago, Florida, and Los Angeles, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 80 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com
Robert S. Willoughby
SOURCE Pomerantz LLP