Portola Phramaceuticals (PTLA)

[H2R]

PR from PTLA:

http://investors.portola.com/phoenix.zhtml?c=198136&p=irol-newsroomArticle&ID=2380212

SOUTH SAN FRANCISCO, Calif., Dec. 11, 2018 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (Nasdaq: PTLA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has extended the review period for the Company’s marketing authorization application (MAA) for Ondexxya™ (andexanet alfa), and cancelled the Oral Explanation scheduled for Wednesday, December 12, 2018. An opinion is now expected by February 28, 2019.

The CHMP informed Portola yesterday that it will provide a list of outstanding questions related to the data package the Company submitted for Ondexxya last quarter, which will require additional responses from the Company. The preliminary timetable provided to the Company by the CHMP sets a deadline of January 29, 2019 for responses to the questions followed by a 30-day assessment period for the CHMP to review the Company’s responses.

Ondexxya is under review for the reversal of the anticoagulant effects of the Factor Xa inhibitors apixaban and rivaroxaban in patients experiencing uncontrolled or life-threatening bleeding.

“We will work diligently to address the Committee’s questions as they review and further consider the data package supporting the MAA,” said Scott Garland, Portola’s president and chief executive officer. “We look forward to continuing the dialogue as we progress toward a formal opinion and potential European approval early next year.”

Andexanet alfa was approved by the U.S. Food and Drug Administration in May 2018 and is marketed by Portola in the U.S. under the trade name Andexxa® [coagulation factor Xa (recombinant), inactivated-zhzo].

PTLA PR'ed one day after being informed on the CHMP questions. I don't know what else they can do but respond ASAP. Kind of too bad, but does not look like a big deal. At least, the CHMP is examining the submission.A delay.

One of the major catalyst is coming up, the PAS ... this month.
I just checked, it's still on for "Dec. 31st" :
https://www.biopharmcatalyst.com/calendars/pdufa-calendar