Amgen, Inc. (NASDAQ:AMGN) announced the submission of a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) via the centralized procedure for etelcalcetide (formerly AMG 416) for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis therapy. If approved, etelcalcetide will be the first calcimimetic agent that can be administered intravenously.
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.
“Secondary hyperparathyroidism affects many of the approximately two million people throughout the world on dialysis, yet there is currently no calcimimetic that can be administered intravenously at the end of scheduled dialysis sessions. Given that these patients take an average of 19 pills daily, there is an opportunity to improve their treatment as it relates to the administration of the therapy,” saidSean E. Harper, M.D., executive vice president of Research and Development atAmgen. “Etelcalcetide has the potential to fill this unmet need, and we look forward to working with regulatory authorities in hopes of providing a new treatment option that could help improve the complex management of the disease.”
The MAA submission for etelcalcetide includes data from three Phase 3 studies, all of which met their 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 today at $152.35 up $4.89 or 3.32%. 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 $163.75 and its 200-day moving average is $159.75.
On the ratings front, Amgen has been the subject of a number of recent research reports. In a report released today, Raymond James analyst Christopher Raymond initiated coverage with a Hold rating on AMGN. Separately, on the same day, Bernstein Research’s Geoff Porges assigned a Hold rating to the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Christopher Raymond and Geoff Porges have a total average return of 47.7% and 3.0% respectively. Raymond has a success rate of 80.5% and is ranked #13 out of 3742 analysts, while Porges has a success rate of 25.0% and is ranked #2006.
Overall, 4 research analysts have assigned a Hold rating and 6 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $178.90 which is 20.0% above where the stock opened today.