Shares of Portola Pharmaceuticals Inc. (PTLA) were down 2.6% to $49.50 ahead of the market open on Wednesday, Nov. 22, following an announcement that the U.S. Food and Drug Administration has extended the review period for the firm's prior approval supplement (PAS) for Bevyxxa (betrixaban).
Bevyxxa is an anticoagulant for hospital and extended duration prophylaxis of venous thromboembolism in acutely ill adults.
In a news release issued after the market close on Tuesday, the South San Francisco, Calif.-based company said it was notified by the FDA that it will respond to the PAS request to change the current manufacturing release specification within the standard 60-day extension period. Jan. 30, 2018 is the new action date.
"As we communicated earlier this month, we've made good progress with the FDA and have established an agreement in principle on the change to our product release specification that would allow for the release and distribution of current product inventory," said Portola CEO Bill Lis in a statement. "We also noted that the agency might need additional time to review our submission."
Lis added that the company is continuing its commercial and medical education efforts in anticipation of a potential launch by February 2018.
The FDA approved Bevyxxa in June.