Blueprint Medicines Corp (NASDAQ: BPMC) shares are trading lower by 22.2% to $53.32 Wednesday morning after the company announced top-line results from the registrational Part 2 of the PIONEER clinical trial of AYVAKIT in patients with non-advanced systemic mastocytosis.
What Happened?
Blueprint Medicines says the trial, which was designed to assess AYVAKIT plus best available care versus placebo plus best available care (control arm), achieved its primary endpoint with a highly significant difference in the mean change in total symptom score (TSS) at 24 weeks (p=0.003).
Based on reported top-line data, Blueprint Medicines plans to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for AYVAKIT in non-advanced SM in the fourth quarter of 2022, with subsequent submission of a type II variation marketing authorization application to the European Medicines Agency (EMA) anticipated in 2023.
Blueprint Medicines also plans to present detailed data from the PIONEER trial at an upcoming medical meeting.
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According to data from Benzinga Pro, Blueprint Medicines has a 52-week high of $117.86 and a 52-week low of $43.46.
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