Correvio Pharma Corp. Class Action Lawsuit
- Company Name
- Correvio Pharma Corp.
- Stock Symbol
- Class Period
- October 23, 2018 to December 5, 2019
- Southern District of New York
On December 12, 2019, the Correvio Pharma Corp. class action lawsuit was filed charging Correvio Pharma and certain of its officers with violations of the Securities Exchange Act of 1934. The Correvio Pharma class action lawsuit was commenced in the Southern District of New York on behalf of purchasers of Correvio Pharma securities between October 23, 2018 and December 5, 2019 (the “Class Period”) and is captioned Feierstein v. Correvio Pharma Corp., et al., No. 19-cv-11361.
Correvio Pharma is a specialty pharmaceutical company that engages in developing therapeutics worldwide. Correvio Pharma’s portfolio of marketed brands includes, 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 died following the administration of 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 United States. Correvio Pharma’s U.S. Securities and Exchange Commission filings would later characterize the patient death 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 Pharma 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 Correvio Pharma had accumulated, as well as discussions with the FDA regarding the drug’s potential regulatory path forward. Correvio Pharma later announced on July 25, 2019, that the FDA had accepted the Resubmitted NDA.
The Correvio Pharma class action lawsuit alleges that throughout the Class Period, defendants made materially false and misleading statements and/or failed to disclose adverse information regarding Correvio Pharma’s business and operations, including that 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, which substantially diminished the likelihood that the FDA would approve the Resubmitted NDA. As a result of this information being withheld from the market, Correvio Pharma shares traded at artificially inflated prices during the Class Period.
Then 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 Pharma’s stock price fell $0.86 per share, or nearly 40%, to close at $1.30 per share on December 6, 2019.
Subsequently, on December 10, 2019, the NASDAQ suspended trading in Correvio Pharma securities in anticipation of the FDA’s Cardiovascular and Renal Drugs Advisory Committee’s (“RDAC”) review and discussion of the Resubmitted NDA. Later 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.
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