Stock Update (NASDAQ:AMGN): Amgen, Inc. Submits Application To FDA For New Delivery Option For Monthly Administration Of Repatha

Amgen, Inc. (NASDAQ:AMGN) announced the submission of an application to the U.S. Food and Drug Administration (FDA) seeking approval of a single-dosing option for the monthly administration of RepathaTM (evolocumab) Injection, allowing the 420 mg monthly dose to be administered as a single injection. Approved by theFDA on Aug. 27, 2015, Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that reduces the liver’s ability to remove low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, from the blood.1

Repatha is approved as an adjunct to diet and maximally tolerated statins in patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), who require additional lowering of LDL-C. The effect of Repatha on cardiovascular morbidity and mortality has not been determined.

“We are very excited about the recent approval of Repatha in the U.S. as a new treatment option for patients who are in need of lowering their LDL cholesterol,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “In addition to the SureClick® autoinjector, we are developing this monthly single injection to provide patients with another option to administer Repatha every month. Patients who are in need of lowering their cholesterol levels are often on more than one medication and some may prefer a single-dose option for receiving Repatha once monthly.”

Repatha is available as a single-use 140 mg/mL prefilled SureClick autoinjector or prefilled syringe that patients can self-administer at the recommended dose for adults of 140 mg every two weeks or 420 mg once a month. For patients with HoFH, the recommended dose is 420 mg once a month. (Original Source)

Shares of Amgen closed yesterday at $153.14. 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 $161.98 and its 200-day moving average is $159.53.

On the ratings front, Amgen has been the subject of a number of recent research reports. In a report issued on September 8, UBS analyst Matt Roden upgraded AMGN to Buy, with a price target of $168, which implies an upside of 9.7% from current levels. Separately, on September 2, Bernstein Research’s Geoff Porges assigned a Hold rating to the stock .

According to, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Matt Roden and Geoff Porges have a total average return of 31.9% and 5.8% respectively. Roden has a success rate of 81.4% and is ranked #57 out of 3754 analysts, while Porges has a success rate of 50.0% and is ranked #1770.

Overall, 3 research analysts have assigned a Hold rating and 5 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 $189.20 which is 23.5% above where the stock closed yesterday.


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