Sep. 8, 2014, 1:48 PM
Sep. 8, 2014, 12:49 PM
Sep. 8, 2014, 9:15 AM
Sep. 5, 2014, 1:28 PM
Sep. 5, 2014, 11:49 AM
- The FDA approves Keryx Biopharmaceuticals' (KERX -6.2%) ferric citrate (formerly Zerenex) for the control of serum phosphate levels in patients with chronic kidney disease on dialysis.
- Keryx CEO Ron Bentsur says, "We are thrilled with the FDA's decision to approve ferric citrate and look forward to bringing it to market in the U.S. within the next 12 weeks."
- The FDA recently informed the company that its approval of the brand name Zerenex was rescinded. A new brand name will identified on or prior to launch.
May 22, 2014, 5:36 PM
- The FDA has extended its goal date for reviewing Keryx's (KERX) new drug application for its Zerenex hyperphosphatemia drug by 3 months to Sep. 7.
- The FDA's notification letter states Keryx's most recent submission included substantial revisions to the chemistry, manufacturing, and controls section of its NDA, and thus considers it a major amendment to the NDA.
May 8, 2014, 1:54 PM
- Investors turn a cold shoulder to Keryx Biopharmaceuticals (KERX -13.1%) after its earnings report and conference call today. Shares gapped down 10% at the open and haven't looked back. Apparently certain comments by CEO Ron Bentsur about Zerenex made some observers perceive some risk to its June 7 PDUFA date.
- Q1 license revenue: $10M (+42.9%); operating expenses: $23.7M (+157.6%); loss/share: ($0.15) (-400%); liquid assets: $155.1M (+178.5%).
May 8, 2014, 9:16 AM
Mar. 26, 2014, 1:22 PM
- Shareholders of Keryx Biopharmaceuticals (KERX) want to give Congress a hug after its proposal to delay putting ESRD drugs into to the ACA-mandated payment bundle until 2024 instead of 2016.
- This bodes well for the company's lead compound, KRX-0502, a treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis.
- The product's PDUFA date is June 7.
- Shares are up 18% on a 3x surge in volume in today's trading.
Mar. 26, 2014, 12:46 PM
Jan. 22, 2014, 9:09 AM
Jan. 17, 2014, 9:13 AM
Jan. 17, 2014, 8:36 AM
- Keryx Biopharma (KERX) +8.3% premarket on news that its Japanese partner, Japan Tobacco, has received marketing approval for ferric citrate from the Japanese Ministry of Health.
- Ferric citrate, to be marketed in Japan under the brand name Riona, is indicated as an oral treatment for the improvement of hyperphosphatemia in patients with chronic kidney disease, including dialysis and non-dialysis dependent CKD.
- KERX will receive $10M for the marketing approval milestone and double-digit tiered royalties, plus up to an additional $55M upon certain annual net sales milestones.
Nov. 5, 2013, 1:51 PM
Nov. 5, 2013, 12:46 PM
Nov. 5, 2013, 9:18 AM
KERX vs. ETF Alternatives
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.
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