Archive for December, 2017
Portola Announces a Delay in PDUFA Date for AndexXa (PTLA, Buy, $54.86)
Portola announced after the close on December 22, 2017 that the FDA will extend its review of AndexXa (andexanet alfa) by 90 days. According to the Company, it just submitted additional data requested by the agency for the ongoing ANNEXA-4 study as part of the continuing review process. This constitutes an amendment to the submission […]
Antares’ Response to Complete Response Letter on Xyosted is in Line with My Expectations (ATRS, Buy, $2.05)
Antares Pharma announced on December 21st that it had submitted a request to the FDA for a type A meeting in response to the CRL that it received in October on Xyosted. This action and timing is in line with what I have been expecting. See my note of November 9, 2017: My Hypothesis on […]
Portola: US Launch of Bevyexxa Is Scheduled for Early January 2018 (PTLA, Buy, $50.03)
Portola Pharmaceuticals announced today that the FDA has given the go-ahead for the commercial launch of Bevyxxa (betrixaban). This drug was approved in the US on June 23, 2017 and at the time Portola said that it expected to launch Bevyexxa in the US in the September to November time frame. However, in early September […]