After Initial Rejection, FDA Approves Ardelyx's Kidney Disease-Related Drug

The FDA approved Ardelyx Inc's ARDX Xphozah (tenapanor), the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. 

Xphozah is a single tablet taken twice daily that blocks phosphate absorption through its primary pathway.

In 2021, the FDA declined approval for Xphozah (tenapanor), noting the magnitude of the treatment effect as "small and of unclear clinical significance." 

In November last year, The FDA adcomm panel, however, recommended Xphozah's approval as a monotherapy or in combination with phosphate binder treatment.

Ardelyx has also amended the debt financing agreement with investment affiliates managed by SLR Capital Partners (SLR), which it originally entered into in February 2022. 

The amendment includes access to an additional $50 million in committed debt financing at Ardelyx's election, and, subject to SLR credit approval, may be further increased by an additional $50 million. 

The interest-only period for existing and new tranches funded under the instrument is extended to December 31, 2026, effective upon Ardelyx's decision to draw the second tranche of $22.5 million. 

Ardelyx expects to draw the second tranche in October to support the commercial launch of Xphozah.

Price Action: ARDX shares are up 16.20% at $4 premarket on the last check Wednesday.