We could not find any results for:
Make sure your spelling is correct or try broadening your search.
Share Name | Share Symbol | Market | Type |
---|---|---|---|
Amgen Inc | NASDAQ:AMGN | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
33.02 | 11.86% | 311.41 | 311.40 | 311.95 | 322.54 | 308.68 | 313.42 | 9,644,684 | 00:59:30 |
By Ezequiel Minaya
Amgen Inc. said Wednesday that government regulators have rejected its new drug application for its therapy for a hormonal imbalance common in patients on dialysis.
Shares of the drugmaker slipped 0.35% to $170.25 in after-hours trading.
Amgen said it expects to meet with the U.S. Food and Drug Administration to discuss the agency's decision sometime later this year. The company said it was reviewing the government response but didn't provide specifics.
The FDA issued the complete response letter in reply to Amgen's petition for etelcalcetide, an intravenous treatment for secondary hyperparathyroidism in patients with chronic kidney disease.
The biopharmaceutical company acquired the treatment, also known by the marketing name Parsabiv, as part of its $315 million acquisition of KAI Pharmaceuticals in July 2012.
According to Amgen, secondary hyperparathyroidism affects many of the roughly two million people globally who receive dialysis, including some 450,000 people in the U.S.
Write to Ezequiel Minaya at ezequiel.minaya@wsj.com
(END) Dow Jones Newswires
August 24, 2016 19:05 ET (23:05 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
1 Year Amgen Chart |
1 Month Amgen Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions