FDA Accepts Amgen's New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide

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Go back to FDA Accepts Amgen's New Drug Application For Novel Intravenous Calcimimetic Etelcalcetide

Cytokinetics (CYTK) and Amgen Inc. (AMGN) Announce COSMIC-HF Data; Roth Capital Raises Price Target to $22

November 9, 2015 7:32 AM EST

Roth Capital maintained a Buy rating on Cytokinetics (NASDAQ: CYTK), and raised the price target to $22.00 (from $18.00), following announced full data from COSMIC-HF at AHA. The large data set was announced jointly by Cytokinetics and global partner Amgen (NASDAQ:... More

Amgen's (AMGN) NDA for Etelcalcetide Accepted by FDA

November 6, 2015 4:02 PM EST

Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review Amgen's New Drug Application (NDA) for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) on hemodialysis. If approved, etelcalcetide will be the first calcimimetic agent that can be administered... More