Portola Pharmaceuticals Inc. (NASDAQ: PTLA) shares saw a handy gain on Tuesday after the company announced that it received a key approval from the U.S. Food and Drug Administration (FDA). Specifically, the FDA approved the company’s Prior Approval Supplement (PAS) for Bevyxxa (betrixaban) ahead of its scheduled January 30 action date, allowing for the release and distribution of its current product inventory.
The company plans to initiate commercial launch in early January 2018 and will provide an update on January 9.
Previously, Bevyxxa was approved by the FDA on June 23 this year as a single-drug regimen in the hospital and following discharge for a treatment duration of 35 to 42 days for the prevention of venous thromboembolism (VTE) in adult patients.
For some quick background on VTE: it is a condition where blood clots form in the deep veins of the leg (known as deep vein thrombosis). These clots can travel in the circulation and lodge in the lungs (known as pulmonary embolism).
Bill Lis, CEO of Portola, commented:
We are pleased to be able to make Bevyxxa available to acute medically ill patients at high risk of venous thromboembolism beginning in January 2018. VTEs result in approximately 100,000 deaths annually in the U.S. in acute medically ill patients – and they are preventable. As the first and only anticoagulant approved as a single-drug regimen administered in the hospital and following discharge for a treatment duration of 35-42 days, Bevyxxa has the potential to impact public health in the U.S. and beyond, if approved in other countries. We thank the FDA for its guidance throughout the review process and look forward to continuing our collaborative efforts with the agency for the benefit of patients.
Excluding Tuesday’s move, Portola has more than doubled in 2017 alone, with its stock up 112%. Over the past 52 weeks, the stock is up closer to 153%.
Shares of Portola were up about 5% at $50.00 Tuesday morning, with a consensus analyst price target of $75.00 and a 52-week range of $18.63 to $67.10.