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Fly News Breaks for July 31, 2015
AMGN, LGND
Jul 31, 2015 | 08:52 EDT
Roth Capital notes Amgen (AMGN) reported Q2 Kyprolis sales of $119M compared to its estimate of $117M. The drug, alongside Promacta, represent the majority of Ligand's current royalty stream, the firm tells investors. It believes the growth of Kyprolis highlights Ligand's "strong core royalty bearing asset lineup." Roth keeps a Buy rating on the stock with a $135 price target.
News For LGND;AMGN From the Last 2 Days
AMGN
Apr 26, 2024 | 09:02 EDT
Amgen announced the imminent submission of a Marketing Authorization Application, or MAA, to the European Medicines Agency, or EMA, for teprotumumab, a fully human monoclonal antibody and targeted inhibitor of the insulin-like growth factor-1 receptor, or IGF-1R, for the treatment of moderate to severe Thyroid Eye Disease, or TED, in adults. TED is a serious, progressive, debilitating and potentially vision-threatening autoimmune disease that can cause proptosis, diplopia, eye pain, redness and swelling.1 If approved, teprotumumab would be the first and only medicine approved for TED in the European Union. The MAA is supported by multiple well-controlled clinical studies - a Phase 2 clinical study NCT01868997, Phase 3 confirmatory clinical study OPTIC NCT03298867, a Phase 4 study NCT04583735, and a Phase 3 clinical trial in Japan OPTIC-J, jRCT2031210453 - providing statistically significant and clinically meaningful improvements across multiple facets of TED, including in proptosis and diplopia, among the 287 total patients studied. Additionally, the studies assessed TED signs and symptoms such as pain, inflammation, redness and functional vision. Clinical improvements were seen in proptosis as early as six weeks, with continued improvement across the 24-week treatment period.2 Teprotumumab has a well-established safety profile.