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Tuesday, Oct 8
Keryx +3% after Zerenex NDA filing accepted by FDA
- Keryx Biopharmaceuticals (KERX) +3.1% premarket after announcing its New Drug Application for Zerenex has been accepted for filing by the FDA.
- The NDA seeks approval for the marketing and sale of Zerenex as a treatment for elevated serum phosphorus levels in patients with chronic kidney disease on dialysis.
- Included in the NDA filing are safety and efficacy datasets derived from Phase 3 registration, as well as data from several additional studies, including four Phase 3 studies conducted in Japan in CKD patients on dialysis.