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KERX

Keryx

$6.40

0.2 (3.23%)

09:56
01/12/17
01/12
09:56
01/12/17
09:56

Keryx announces publication of Auryxia Phase 3 results

Keryx Biopharmaceuticals announced the publication of results from its pivotal Phase 3 study evaluating ferric citrate for iron deficiency anemia in non-dialysis-dependent chronic kidney disease in the online issue of the Journal of the American Society of Nephrology. Ferric citrate (Auryxia) is currently indicated in the U.S. as a phosphate binder for the control of serum phosphorus levels in patients with CKD on dialysis. Data in the publication highlight an investigational use of ferric citrate as a potential oral treatment for adults with IDA and NDD-CKD. The article titled, "Effects of Ferric Citrate in Patients with Non-Dialysis-Dependent CKD and Iron Deficiency Anemia," describes previously reported Phase 3 results, in which ferric citrate achieved statistically significant results on the primary and all five pre-specified secondary endpoints for the treatment of IDA in adults with NDD-CKD versus placebo. Patients enrolled in the trial had not adequately responded to or could not tolerate prior treatment with oral iron. In the Phase 3 study, ferric citrate was generally well tolerated and adverse events were consistent with its known safety profile, with diarrhea reported as the most common adverse event. "The results shown in this pivotal study demonstrated that ferric citrate, if approved for this indication, could provide an important new treatment option for people living with chronic kidney disease and iron deficiency anemia who are not on dialysis," said Steven Fishbane, M.D., chief of nephrology for North Shore University Hospital and Long Island Jewish Medical Center. "Not only did ferric citrate deliver a clinically meaningful 1 g/dL increase in hemoglobin levels for the majority (52.1 percent (61/117)) of patients treated in the Phase 3 study at any point during the 16-week efficacy period, increases were seen as early as one to two weeks after start of treatment, and were sustained for the majority of patients who achieved the primary endpoint." "Clinical trials are critical to the advancement of safe and effective medicines, and we thank the patients, their families and the renal care teams who have participated in clinical trials for ferric citrate," said John Neylan, M.D., chief medical officer of Keryx Biopharmaceuticals. "We are pleased to have these data highlighted by a major nephrology journal, which can provide broad access for nephrologists to the Phase 3 results. We recently submitted a supplemental new drug application with these data to the U.S. FDA. If approved for this expanded indication, ferric citrate would be the first oral medicine approved by the FDA for the treatment of iron deficiency anemia in patients with NDD-CKD."

KERX Keryx
$6.40

0.2 (3.23%)

11/09/16
MAXM
11/09/16
UPGRADE
Target $7
MAXM
Buy
Keryx upgraded to Buy at Maxim
As previously reported, Maxim analyst Justin Lumiere upgraded Keryx Biopharmaceuticals to Buy from Hold after the FDA approved its application for a second contract manufacturer, Patheon, to make Auryxia. The analyst, who believes from management's call that production will likely be in place by 1Q17 and that the company will be building supply now to make sure there are no further interruptions once Auryxia is reintroduced, sees 2017 U.S. sales of the drug doubling to $44M from the $22M he projects for 2016. Lumiere reinstated a $7 price target on Keryx shares.
11/29/16
RAJA
11/29/16
NO CHANGE
RAJA
Keryx weekly Auryxia scripts at highest level ever, says Raymond James
11/29/16
RAJA
11/29/16
NO CHANGE
RAJA
Outperform
Update: Keryx weekly Auryxia scripts at highest level ever, says Raymond James
Ramond James analyst Reni Benjamin said total Auryxia scripts of 792 for the week of November 14, the first full week after the commercial supply of the drug was restored. Benjamin had expected Auryxia to gain clinical adoption once back on the market given our survey results but had not modeled IMS scripts to reach a record level within a week. The analyst has increased confidence that Auryxia will regain its sales momentum with potential to exceed his revenue estimate of $30M as well as consensus estimates for 2017. Benjamin rates Keryx an Outperform.
01/11/17
SBSH
01/11/17
UPGRADE
Target $6.5
SBSH
Neutral
Keryx upgraded to Neutral from Sell at Citi
Citi analyst Yigal Nochomovitz upgraded Keryx Biopharmaceuticals to Neutral saying Auryxia re-launch data is exceeding his expectations. The analyst raised his 2017 Auryxia sales estimate in dialysis to $45M from $19M and upped his price target for the shares to $6.50 from $4.

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