Amgen (AMGN) Announces KYPROLIS Phase 3 CLARION Trial Missed Primary Endpoint
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Amgen (AMGN) Announces Erenumab Phase 3 Met Primary Endpoint in Migraine Prevention
September 28, 2016 4:31 PM EDTAmgen (Nasdaq: AMGN) announced positive top-line results for erenumab (AMG 334) from A Phase 3, RandomIzed, double-blind, placebo-controlled Study to Evaluate the efficacy and safety of erenumab in migraine prevention (ARISE). These data showed the ARISE study met the primary endpoint, demonstrating a statistically significant reduction from baseline in monthly migraine days in patients with episodic migraine treated with erenumab compared with placebo at 12 weeks. Erenumab is specifically designed to prevent migraine by blocking the Calcitonin Gene-Related Peptide (CGRP) receptor, which is believed to have a critical role in mediating the incapacitating pain of... More
Roth Capital Trims PT on Ligand Pharma (LGND) to $150 Amid New Kyprolis Data (AMGN)
September 27, 2016 10:15 AM EDTRoth Capital lowers its price target on Buy-rated Ligand Pharmaceuticals (Nasdaq: LGND) from $151 to $150 following Kyprolis data out from Amgen (Nasdaq: AMGN) earlier today.
The firm commented, This is an unfortunate bump for Kyprolis. While Amgen has... More
Amgen (AMGN), UCB Announce FDA Acceptance of BLA For Romosozumab
September 26, 2016 4:01 PM EDTAmgen (NASDAQ: AMGN) and UCB today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for romosozumab, an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at increased risk of fracture. Romosozumab works by binding and inhibiting the activity of the protein... More
Amgen's (AMGN) AMJEVITA Approved by U.S. FDA
September 26, 2016 6:23 AM EDTAmgen (Nasdaq: AMGN) announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA (adalimumab-atto) across all eligible indications of the reference product, Humira® (adalimumab). AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment of seven inflammatory diseases, including moderate-to-severe rheumatoid arthritis, moderate-to-severe polyarticular juvenile idiopathic arthritis, psoriatic arthritis,... More
