NVS - Blueprint stock falls 9% on swapping goals of Ayvakit trial after FDA directive
Blueprint Medicines (NASDAQ:BPMC) stock fell ~9% on June 9 after the company said that it will swap the objectives of a key study of its medicine Ayvakit after recommendation from the U.S. Food and Drug Administration (FDA) The company is evaluating Ayvakit (avapritinib) in a trial called PIONEER to treat patients with non-advanced systemic mastocytosis (SM). SM is a rare disorder which occurs due to build of large number of mast cells, a a type of white blood cell, in the body. SM can also become cancerous. The company said that the mean absolute change in total symptom score (TSS), which was previously a key secondary goal, will be the main goal, while the proportion of patients with a 30% or greater decrease in TSS, previously the main objective, will now become a key secondary endpoint. The changes are being made based on a written recommendation by the FDA on statistical considerations ahead of the planned
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Blueprint stock falls 9% on swapping goals of Ayvakit trial after FDA directive