Amgen, Inc. (NASDAQ:AMGN) shares were up 1.91% on Wednesday when approximately 3.92M shares were traded, against the average daily trading volume of 3.40M. Analysts at Credit Agricole recently upgraded the stock to Underperform from Buy. Amgen, Inc. (NASDAQ:AMGN) has a consensus buy rating, according to Zacks Investment Research. No analyst has rated the stock with a sell rating, 10 have assigned a hold rating, 1 says it’s a buy, and 5 have assigned a strong buy rating to the company.
Analysts have a consensus target price of $181.78 in the 12-month period. The price objective is 13.85% higher than the recent closing price of $159.67. The 52-week price range is $132.74-$175.66 and the company has a market capitalization of $118.78 billion.
Amgen, Inc. (AMGN) on January 27, 2017 announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the Marketing Authorization of ABP 501 (biosimilar adalimumab), recommending approval for all available indications. ABP 501 has been recommended for approval for the treatment of certain inflammatory diseases in adults, including moderate-to-severe rheumatoid arthritis, psoriatic arthritis, severe ankylosing spondylitis (AS), severe axial spondyloarthritis without radiographic evidence of AS, moderate-to-severe chronic plaque psoriasis, moderate-to-severe hidradenitis suppurativa, non-infectious intermediate, posterior and panuveitis, moderate-to-severe Crohn’s disease and moderate-to-severe ulcerative colitis. The CHMP opinion also recommends approval for the treatment of certain pediatric inflammatory diseases, including moderate-to-severe Crohn’s disease (ages six and older), severe chronic plaque psoriasis (ages four and older), enthesitis-related arthritis (ages six and older) and polyarticular juvenile idiopathic arthritis (ages two and older).
“The positive CHMP opinion for ABP 501 marks the first time an adalimumab biosimilar has been recommended for approval in the EU,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “This represents another significant milestone for our biosimilars portfolio and is an important step in our effort to develop high-quality biologic medicines for patients suffering from chronic inflammatory diseases.”
The Marketing Authorization Application (MAA) submission for ABP 501 was based on a comprehensive data package supporting biosimilarity to adalimumab based on analytical, pharmacokinetic and clinical data, including results from two Phase 3 studies conducted in moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis patients. The Phase 3 studies each met their primary endpoint showing no clinically meaningful differences to adalimumab. Safety and immunogenicity of ABP 501 were also comparable to adalimumab. Data to support the transition of adalimumab patients to ABP 501 were also included in the submission.
