Biotech Values

[DewDiligence]

PTLA—(-9%/AH)—FDA delays AndexXa PDUFA date to 5/4/17:

https://finance.yahoo.com/news/portola-pharmaceuticals-provides-biologics-license-222321546.html

Portola Pharmaceuticals today announced that the U.S. Food and Drug Administration (FDA) will extend its review of the Biologics License Application (BLA) for AndexXa (andexanet alfa) by 90 days. The company recently submitted additional data requested by the agency for the ongoing ANNEXA-4 study as part of the continuing review process, which constitutes an amendment to the submission. Therefore, the agency has instituted an extension to allow more time for a thorough review of the information provided and to work with the company on labeling and post-marketing commitments. In correspondence dated and issued today, the FDA communicated that the action date will move from February 3, 2018 to May 4, 2018.