Correvio Pharma Corp. (CORV) Accused of Misleading Shareholders
According to the complaint for alleged violations of the Securities Exchange Act of 1934 between October 23, 2018 and December 5, 2019, during Correvio’s development of Brinavess, safety concerns led the U.S. Food and Drug Administration (“FDA”) to decline approval for Brinavess and mandate a clinical hold on the Brinavess program following the death of a patient who had been administered the drug during one of its clinical trials. Then, in October 2018, Correvio announced its intention to resubmit a New Drug Application (“NDA”) to the FDA for recent onset AF supported by additional purported safety data that the Company had accumulated. On July 25, 2019, Correvio announced that the FDA had accepted the resubmitted NDA. Contrary to Correvio’s representations, on December 6, 2019, the FDA announced that it did not believe the drug’s benefits outweighed its risks, specifically highlighting “serious liabilities” associated with Brinavess, including even death. Consequently, on December 10, 2019, the FDA voted against approval of the NDA. On this news, Correvio shares fell 67% to close at $0.46 per share. The stock continues to decline.
