Keryx Biopharmaceuticals (KERX) Auryxia Has Analyst Boris Peaker Expecting Positive Chances for Approval in Pre-Dialysis Today; Here’s Why

Cowen weighs in on encouraging ANS Phase III data expecting green light for KERX's ferric citrate tablets.

Keryx Biopharmaceuticals (NASDAQ:KERX) shares flew on an almost 11% upturn on Friday after the drug maker’s ferric citrate tablets known as Auryxia impressed in additional analyses from the Phase III trial in adults with iron deficiency anemia and non-dialysis dependent chronic kidney disease patients.

Investors must have liked what they heard at Thurday’s American Society of Nephrology (ASN) meeting, where Keryx showcased back-to-back post-hoc read-outs that offered a magnifying glass to the impact of ferric citrate on both the levels of serum phosphate as well as FGF23. The verdict? Phosphate and FGF23 in these patients were lowered.

Cowen analyst Boris Peaker takes the presentation of this real world dialysis data in stride as showing Auryxia in a promising light, noting: “The data shows ferric citrate’s benefit in reducing phosphate and FGF23 in these patients. We view the findings as incrementally positive and anticipate approval for pre-dialysis on Nov 6th. We believe the approval is already priced into the stock.”

With approval expected for Keryx’s Auryxia in pre-dialysis today, the analyst highlights that the statistically significant reduction of serum phosphorous measurements do not come as a shock, offering context on the Phase III trial analyses: “This finding is not surprising since ferric citrate is currently approved under the brand name Auryxia as a phosphate binder in dialysis patients. As such, we anticipate it to have the same effect in pre-dialysis patients. The data further indicated that in pre-dialysis patients phosphorus reduction was only observed in patients with elevated baseline phosphorus and was also proportionate to the baseline levels. There was no notable effect on serum phosphorus in patients with normal level at baseline (<4.5mg/dL) and no hypophosphatemia was reported. We believe the lack of hypophosphatemia is an important safety data point, but the observed phosphate reduction is unlikely to materially impact adoption of the drug in pre-dialysis.”

Concluding on a cautious note, Peaker adds that while he anticipates approval “shortly,” these findings may “point in a favorable direction,” but long-term it is less clear how meaningfully on a clinical basis these phosphate and FGF23 reductions will impact patients. Therefore, while approval looks good for Keryx, Auryxia’s commercial adoption in pre-dialysis down the line, should the agency include the data in the formal label of the drug, is less definitively shaped by the Phase III results, even if the data is encouraging. Are the FGF23 reductions clinically meaningful? The data presented does not palpably spell out long-term reduction, making the FGF23 findings tricky to “interpret” in the grander scheme.

For now, the analyst keeps a watchful eye on the biotech player from the sidelines, maintaining a Market Perform rating on Keryx stock without listing a price target. (To watch Peaker’s track record, click here)

Additionally, according to 6 analysts polled by TipRanks, in the last 12 months, most align with Peaker’s stance, with 2 rating a Buy on Keryx stock while 4 maintain a Hold. The 12-month average price target stands at $7.30, marking a nearly 15% upside from current levels.

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