Keryx Biopharmaceuticals (NASDAQ:KERX) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of ferric citrate coordination complex (EU approved brand name Fexeric®) recommending approval for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in adults with chronic kidney disease (CKD). Fexeric was approved under the brand name Auryxia™ by the U.S. Food and Drug Administration in September 2014, and is indicated in the U.S. for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.
“We are pleased to receive this positive opinion from the CHMP for Fexeric, as it is an important step in providing a new treatment option in phosphorus management for adult patients with CKD in both the non-dialysis and dialysis settings,” said John Neylan, M.D., chief medical officer of Keryx. “We look forward to the European Commission’s decision in the coming months.”
The CHMP positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 28 countries of the European Union (EU) and Iceland,Norway and Liechtenstein. The EC generally follows the recommendation of the CHMP and typically issues its final opinion approximately two to three months following CHMP opinion. Keryx expects to make a decision about its EU commercial strategy by the end of 2015.
Data Supporting Positive Opinion
The CHMP opinion is based on evidence from approximately 1900 patients, including two key clinical trials: a Phase 2, non-dialysis study and a 58-week, Phase 3 registration trial. In the Phase 3 trial, ferric citrate effectively reduced serum phosphorus levels to well within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL. These data were published in 2014 in the Journal of the American Society of Nephrology.
The most commonly reported adverse events during treatment were discolored feces (18%) and diarrhea (13%). All serious adverse reactions were gastrointestinal in nature (abdominal pain, constipation, diarrhea, gastritis, gastritis erosive, and hematemesis). The most commonly reported adverse reactions in CKD non-dialysis patients during treatment were discolored feces (27%) constipation (13%) and diarrhea (11%). A summary of the CHMP opinion can be accessed at ema.europa.eu. (Original Source)
Shares of Keryx Biopharmaceuticals closed yesterday at $9.26. KERX has a 1-year high of $18.48 and a 1-year low of $8.69. The stock’s 50-day moving average is $9.87 and its 200-day moving average is $11.52.
On the ratings front, Keryx has been the subject of a number of recent research reports. In a report released yesterday, Cowen analyst Boris Peaker downgraded KERX to Hold, with a price target of $18, which represents a potential upside of 94.4% from where the stock is currently trading. Separately, on the same day, Roth Capital’s Joseph Pantginis reiterated a Buy rating on the stock and has a price target of $11.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Boris Peaker and Joseph Pantginis have a total average return of 35.9% and 9.6% respectively. Peaker has a success rate of 57.9% and is ranked #38 out of 3714 analysts, while Pantginis has a success rate of 51.4% and is ranked #212.
The street is mostly Bullish on KERX stock. Out of 5 analysts who cover the stock, 5 suggest a Buy rating . The 12-month average price target assigned to the stock is $20.80, which implies an upside of 124.6% from current levels.
Keryx Biopharmaceuticals Inc is a biopharmaceutical company focused on therapies for patients with renal disease. Its first product is the AuryxiaTM (ferric citrate), an oral, absorbable iron-based compound.