Correvio Pharma Corp CORV shares came under selling pressure Friday after a briefing document released ahead of the company's planned Adcom meeting showed that FDA staffers were not convinced that the benefits of its atrial fibrillation medication Brinavess outweigh the risks.
The shares fell about 40% Friday before recouping a small part of the losses Monday. The stock ended Monday's session up 7.69% at $140.
Trading of the stock was halted Tuesday morning pending the Adcom verdict.
Correvio's Adcom Verdict Looms
FDA's Cardiovascular and Renal Drugs Advisory Committee is meeting to discuss Correvio's NDA for Brinavess, or vernakalant HCl solution.
The specialty pharma company is based in Vancouver, Canada, and was previously known as Cardiome Pharma.
The company is seeking approval of Brinavess, its anti-arrhythmic drug, for the rapid conversion of adult patients with recent onset atrial fibrillation, or AF.
AF is a common cardiac rhythm disturbance — or irregular heartbeat — that sets in with the advancement of age. If left untreated, it can lead to blood clots, stroke, heart failure and other heart-related ailments.
From about 2.7 million to 6.1 million cases in 2010, the incidence of AF is set to increase to 5.6 million to 12 million in 2030, Correvio said, citing American Heart Association estimates.
Brinavess has received marketing authorizations in 41 countries outside of the U.S.
The company resubmitted the NDA on June 24 following a prior rejection, and the FDA accepted the resubmission in late July.
FDA Staffers: Benefits Don't Outweigh Risks
The briefing document released Friday showed that FDA staffers felt the benefits of the drug do not outweigh the risks.
They also pointed to the drug being associated with serious liabilities, including low blood pressure, irregular heartbeats in the lower heart chambers and death.
The FDA, though it often considers the Adcom verdict as well as the discussions of the panel members, is not bound to decide in line with the panel.
Update: The company announced after Tuesday's close that the FDA AdCom Panel voted the benefit-risk profile for Brinavess wasn't adequate to support approval.
The FDA has set a PDUFA action date of Dec. 24.
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