- Akebia Therapeutics is one of three companies attempting to secure a first ever approval for a new type of therapy for Anemia due to Chronic Kidney Disease.
- Its hypoxia-inducible factor prolyl hydroxylase inhibitor ("HIF-PHI") looked a good bet for approval in patients on dialysis and not on dialysis, until a damaging safety data readout.
- Safety is the primary reason for approving HIF-PHIs, since current standards of care ESAs are associated with adverse cardiovascular events.
- Fibrogen's Roxadustat faces an FDA AdComm on its pathway to approval, and Akebia may face the same if the FDA decides to accept its NDA at the end of this month.
- A new drug class that looked very promising is stalling, but in DD-CKD, Akebia does have data sufficient for an approval, potentially. If that happens, shares may spike by >100%, but there is a likely equal chance it won't, creating significant downside risk.
For further details see:
Akebia: Pessimism On Vadadustat Approval Justified, But Risky Bull Case Can Be Made