Breakthrough therapy designation was created by the FDA to expedite the development and review of new drugs for serious or life-threatening conditions. This designation is based on the results of a Phase II proof-of-concept study that showed BYM338 substantially benefited patients with sIBM compared to placebo. The results of this study will be presented at the American Neurological Association meeting on October 14 and is expected to be published in a major medical journal later this year.
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