Biopharma Akebia Therapeutics (AKBA) skyrocketed 38% in Tuesday’s trading after reporting positive topline data from the global Phase 3 clinical trials of vadadustat.
This is the company’s investigational oral hydroxylase inhibitor (HIF-PHI) for the treatment of anemia due to chronic kidney disease (CKD) in adult patients on dialysis.
In the INNOVATE study (dialysis-dependent patient population) of over 3,900 patients; vadadustat achieved both its primary efficacy and cardiovascular safety endpoints.
The treatment demonstrated non-inferiority to darbepoetin alfa as measured by a mean change in hemoglobin (Hb) between baseline and the primary and secondary evaluation periods. It also achieved the primary safety endpoint, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE).
“We believe the data is positive” summed up Mizuho Securities analyst Difei Yang following the announcement. She has a buy rating on the stock and a $15 price target. Even following the stock’s rapid ascent, her price target still indicates upside potential of 26%.
Looking forward, John P. Butler, Akebia CEO stated, “The team is already at work on vadadustat’s New Drug Application (NDA), which we expect to file as quickly as possible following the top-line data readout of PRO2TECT, our global Phase 3 program studying vadadustat in adult patients not on dialysis with anemia due to CKD, which we expect in mid-2020, as planned.”
According to Needham’s Chad Messer, studies in CKD patients who are not on dialysis represents a far larger market opportunity for Akebia. “This [Protect] study design differentiates vadadustat from its primary competitor Astra Zenca’s roxadustat which was tested versus placebo in this population” he notes.
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