AKBA - Akebia's Vafseo Faces Grim Market Outlook (Rating Downgrade)

2024-04-02 06:16:12 ET

Summary

• Akebia's Vafseo, a HIF-PH inhibitor for DD-CKD anemia, faces skepticism despite FDA approval due to safety concerns.
• Market skepticism towards HIF-PH inhibitors, evidenced by GSK's hesitance in Europe, suggests limited adoption for Vafseo.
• Akebia’s financials show modest Q4 net income and a shrinking cash reserve, raising sustainability questions.
• Recommendation: Sell Akebia due to high risk/low reward, despite potential market underestimation of Vafseo and Auryxia.

Akebia's Strategic Bet on Vafseo Amidst HIF-PH Inhibitor Skepticism

My last update on Akebia Therapeutics ( AKBA ) focused on their strides in treating kidney disease. All eyes were on vadadustat for the treatment of anemia in dialysis-dependent adults. The drug is approved in over 30 countries outside the US. Recall that Akebia originally sought a broader indication for the drug (in non-dialysis and dialysis-dependent patients), but the FDA refused to approve vadadustat in March 2022 due to safety concerns. Nonetheless, the FDA kept the door open and Akebia resubmitted the New Drug Application in October. On March 28, the FDA approved vadadustat, Vafseo , for adults with dialysis-dependent chronic kidney disease [DD-CKD]. Vafseo is now the second oral HIF-PH inhibitor approved in the US. GSK's ( GSK ) Jesduvroq was approved for the same indication last year....

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