Keryx Biopharmaceuticals, Inc. announced that the nation’s largest Medicare Part D plan sponsor has added Auryxia (ferric citrate) to its Medicare Part D plan formularies.
Keryx’s share price has decreased 5% year to date, while the Zacks classified Medical - Biomedical and Genetics industry gained 5.5%.
Auryxia is Keryx’s only marketed product and is approved in the U.S. for the control of serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. In the EU, the drug is approved for the control of elevated serum phosphorus levels, or hyperphosphatemia, in adult patients with CKD, including dialysis and non-dialysis dependent (NDD) CKD.
Addition of the drug to Part D plan formularies considerably increases unrestricted access to Auryxia for people on dialysis and their caregivers. Also, it will help in providing access to Auryxia for people with iron deficiency anemia (IDA) and NDD CKD. Going ahead, the pending approval for this indication in the U.S. is expected later in 2017.
There are about 450,000 adult patients in the U.S., who have CKD and require dialysis which is referred as end-stage renal disease (ESRD). These patients also include 350,000 of them currently taking a phosphate binder. To increase adoption of Auryxia for these patients, Keryx’s field-based team is aligned to 95 sales territories, calling on target nephrologists and their associated dialysis centers.
In fact, Medicare Part D and commercial insurance companies cover most of the prescription costs for people with ESRD, including the vast majority of phosphate binder prescriptions.
Moreover, Keryx is working on expanding Auryxia’s label to include the treatment of IDA in adults with stage III–V NDD CKD. In Mar 2017, the FDA accepted the company’s supplemental New Drug Application (sNDA) for Auryxia for review and given a Prescription Drug User Fee Act (PDUFA) target action date of Nov 6, 2017. If approved for this indication, Auryxia could be the first FDA-approved oral medicine to treat IDA in this patient population. A potential approval will in fact, significantly boost sales of Auryxia.
Zacks Rank & Stocks to Consider
Keryx is a Zacks Rank #3 (Hold) stock. Some other better-ranked stocks in the health care sector include Heska Corp. (HSKA - Free Report) , Retrophin, Inc. (RTRX - Free Report) and Addus HomeCare Corp. (ADUS - Free Report) . While Heska and Retrophin carry a Zacks Rank #1 (Strong Buy), Addus HomeCare carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here
Heska’s earnings estimates increased from $1.53 to $1.65 for 2017 and from $1.90 to $2.01 for 2018, over the last 30 days. The company posted a positive earnings surprise in all of the four trailing quarters with an average beat of 291.54%. Its share price increased 33% year to date.
Retrophin’s loss estimates narrowed from 85 cents to 72 cents for 2017 and from 67 cents to 53 cents for 2018, over the last 30 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 80.55%.
Addus HomeCare earnings estimates increased from $1.38 to $1.41 for 2017, over the last 30 days. The company posted a positive earnings surprise in two of the four trailing quarters with an average beat of 10.14%.
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