Biotech Values

[DewDiligence]

PTLA starts phase-3 trial of andexanet alfa (PRT4445) as Eliquis antidote:

http://finance.yahoo.com/news/portola-pharmaceuticals-initiates-phase-3-120000659.html

In the first part of the study, approximately 32 healthy volunteers will be given Eliquis 5 mg twice daily and then randomized in a 3:1 ratio to andexanet alfa administered as a 400 mg IV bolus or to placebo. In the second part of the study, approximately 32 healthy volunteers will be randomized in a 3:1 ratio to andexanet alfa administered as a 400 mg IV bolus followed by a continuous infusion of 480 mg at 4 mg/min for 120 minutes or to placebo. Study participants will be followed for up to 43 days to assess safety.

The PR headline says this trial is under the Accelerated Approval pathway, but I wouldn’t interpret that as a binding commitment by the FDA to grant AA if the study results are positive.