Amgen, Inc. (NASDAQ:AMGN) announced the submission of a New Drug Application (NDA) with the United States Food and Drug Administration (FDA) 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 intravenously at the end of the dialysis session.
“Secondary hyperparathyroidism is a serious, progressive disease that can lead to significant clinical consequences and is also associated with a high pill burden for patients,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We look forward to working with regulatory authorities during the review process to bring this important treatment to market, helping to fill an unmet need for the many patients impacted by this disease.”
Etelcalcetide is a novel calcimimetic agent that suppresses the secretion of parathyroid hormone and is in clinical development for the treatment of SHPT in patients with CKD on hemodialysis. Etelcalcetide is administered intravenously three times per week at the end of each dialysis session. It acts by binding to and activating the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in parathyroid hormone (PTH). Sustained elevations in PTH are known to be associated with significant clinical consequences for patients with CKD.
The submission includes data from three Phase 3 studies, all of which met the primary endpoints, including two pooled placebo-controlled trials in more than 1,000 patients and a head-to-head study evaluating etelcalcetide compared with cinacalcet. (Original Source)
Shares of Amgen closed yesterday at $147.64. AMGN has a 1-year high of $181.81 and a 1-year low of $127.67. The stock’s 50-day moving average is $164 and its 200-day moving average is $159.70.
On the ratings front, Amgen has been the subject of a number of recent research reports. In a report issued on August 17, Deutsche Bank analyst Robyn Karnauskas maintained a Buy rating on AMGN, with a price target of $195, which represents a potential upside of 32.1% from where the stock is currently trading. Separately, on August 12, RBC’s Michael Yee maintained a Buy rating on the stock and has a price target of $190.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Robyn Karnauskas and Michael Yee have a total average return of 9.1% and 3.5% respectively. Karnauskas has a success rate of 56.7% and is ranked #272 out of 3730 analysts, while Yee has a success rate of 52.1% and is ranked #980.
The street is mostly Bullish on AMGN stock. Out of 10 analysts who cover the stock, 6 suggest a Buy rating and 4 recommend to Hold the stock. The 12-month average price target assigned to the stock is $178.90, which implies an upside of 21.2% from current levels.