Biotech Values

[DewDiligence]

PTLA presented updated data from the ANNEXA-4 study at ACC today; however, investors evidently weren’t assuaged regarding the possible need for an RCT to get Andexxa approved by the FDA, as first revealed by PTLA two weeks ago (#msg-138921462):

https://globenewswire.com/news-release/2018/03/12/1420761/0/en/Portola-Pharmaceuticals-Announces-New-Interim-Results-from-Ongoing-ANNEXA-4-Study-of-Factor-Xa-Inhibitor-Reversal-Agent-AndexXa-Andexanet-Alfa-in-Patients-with-Life-Threatening-Ble.html

According to the CC that accompanied the above PR, the FDA is concerned that the rate of “excellent or good” homeostasis in ANNEXA-4 is only 83% at 12 hours, despite the fact that Andexxa returns FXa levels to the normal range in 88% of patients. (I’m using the present tense because the ANNEXA-4 study is ongoing and is still enrolling patients.)

Ct.g listing for ANNEXA-4:
https://www.clinicaltrials.gov/ct2/show/NCT02329327