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Fly News Breaks for May 18, 2018
AGN, TEVA, NVS, AMGN
May 18, 2018 | 05:25 EDT
The FDA, as expected, approved Amgen (AMGN) and Novartis' (NVS) first-in-class anti-CGRP treatment Aimovig for the prevention of migraine, Wells Fargo analyst David Maris tells investors in a research note. The only part of the news which may be somewhat unexpected could be the pricing, which came in at $575 per month or $6,900 annually, the analyst adds. He thinks some investors may have been expecting the price in the $12,000 range. Maris thinks there may be a potential negative read-through on the pricing for Teva (TEVA) and to a lesser extent, Allergan (AGN).
News For AMGN;NVS;TEVA;AGN 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.
NVS
Apr 24, 2024 | 07:26 EDT
TD Cowen analyst Yaron Werber raised the firm's price target on BeiGene (BGNE) to $236 from $235 and keeps a Buy rating on the shares. The firm updated its model to reflect lower collaborative revenue given termination of Novartis (NVS) agreement for tisle in Sep 2023.