Portola Receives FDA Approval For Bevyxxa

The FDA has approved Portola Pharmaceuticals Inc PTLA’s BevyxXa, a blood-thinner for acutely ill patients not undergoing surgery. BevyxXa is the first oral drug of its kind to be approved to help prevent deep vein thrombosis and pulmonary embolisms.

Portola shares are halted on the news, but the stock could see significant upside once trading resumes. Analysts polled by Thompson Reuters estimate that BevyxXa could generate peak sales of more than $1 billion annually by 2023.

Despite relatively weak data from its phase III clinical trials, Portola’s push for FDA approval has paid off.

“Today’s approval is the ultimate milestone for Portola,” Portola CEO Bill Lis said in a statement. “We are grateful to the patients who participated in our trials, the FDA, our academic collaborators and investigators, and, importantly, our dedicated employees who have worked tirelessly to achieve this goal.”

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According to the FDA label, the recommended dose of BevyxXa is an initial dose of 160 mg followed by additional 80 mg doses daily for 35 to 42 days.

Portola’s current market cap stands at just $2.1 billion, but that number could soon get a big boost. Portola shares are already up 71.8 percent so far in 2017.

According to CNN Money, six analysts that cover Portola’s stock have an average price target at $45.50, with the highest target at $51.00.

The stock’s recent run-up began in the high teens in November of 2016. Investors are watching closely to see if the BevyxXa approval pushes the stock above its 2015 highs near $58.