Shares of Teva Pharmaceuticals TEVA are spiking intra-day after the FDA issued a complete response letter for Glatiramer Acetate, Teva's supplemental New Drug Application for a lower volume injection of glatiramer acetate.
The FDA stated, "Unless you can provide a convincing argument that the new /higher concentration lower volume formulation does not have an impact on efficacy, an adequate and well controlled efficacy study will be needed to support efficacy of this new formulation."
The stock has jumped on this news, and is currently trading 3.12% higher at $52.80. Volume has been heavy with more than 8.61 million shares already trading hands compared to a daily average volume of 6.89 million.
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