Portola Pharmaceuticals’ ($PTLA) new drug application has been accepted by the FDA for priority review. The application pertains to its oral, once-daily Factor Xa inhibitor anticoagulant, betrixaban. The company is looking to get the drug approved forextended-duration prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE.
The priority review will have considerably shorter review time of nearly six months. The regular review period is at 10 months. It is likely that the company will receive the results by June 24, 2017. The company also informed that the drug has been accepted for review in the EU as well.
Portola Pharmaceuticals stock showed a rocky performance this year as it lost over 56% of its value during the time. However, in the past one month, it has showed signs of recovery and gained 20%. The latest FDA news is expected to be pivotal for the company.
The pharma company recently collaborated with Pfizer and Bristol-Myers Squibb Co for a $50 million deal. Both the companies will contribute equally towards this unsecured loan. Portola will repay the loan through royalties received from AndexXa commercial sale. The funding will help Portola in resubmitting the Biologics License Application for the therapy.