Blueprint Medicines’ supplemental new drug application for Ayvakit for the treatment of adults with indolent systemic mastocytosis has been accepted by the FDA. The FDA granted priority review with an action date of May 22. This regulatory application is based on results from the global PIONEER trial, the largest randomized, placebo-controlled study ever conducted in indolent SM. The FDA previously granted breakthrough therapy designation to Ayvakit for the treatment of moderate to severe indolent SM.
Published first on TheFly
See today’s best-performing stocks on TipRanks >>
Read More on BPMC:
- Wells Fargo upgrades Blueprint Medicines to Equal Weight with $41 price target
- Blueprint Medicines upgraded to Equal Weight from Underweight at Wells Fargo
- Blueprint Medicines initiated with a Buy at Needham
- Blueprint Medicines price target lowered to $53 from $58 at Barclays
- Blueprint announces AYVAKIT data showing durable response rates, prolonged OS
