Portola Pharma (PTLA) Halted on LUDP
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Portola Pharma (PTLA) Says IndexXa MAA Accepted for Review in Europe
August 19, 2016 8:31 AM EDTPortola Pharmaceuticals Inc. (Nasdaq: PTLA) announced that the MAA for IndexXa (andexanet alfa; trade name in the United States is AndexXa), a Factor Xa inhibitor antidote, has been submitted to the EMA, completed the validation period, and has been accepted for review. IndexXa is in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding and for patients requiring urgent or emergency surgery. Portola is seeking conditional approval of IndexXa in the EU through the centralized procedure. With the acceptance of the... More
Portola Pharma (PTLA) Drops 21% With Andexanet PDUFA Looming
August 17, 2016 3:29 PM EDTPortola Pharma (NASDAQ: PTLA) declined over 20% and was halted on a limit-down pause Wednesday. The company's andexanet alfa PDUFA is today, August 17, 2016. The PDUFA date is the goal date for the FDA to complete its review of the BLA.
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