Positive top-line data from Blueprint Medicines Corp.’s phase I and II trials of Ayvakit (avapritinib) for treating advanced systemic mastocytosis (SM) are pushing the company to submit an sNDA before 2020 ends.

Three biopharma drugs are up for FDA approval this week, including one new chemical entity, dasotraline, from Sunovion Pharmaceuticals Inc. to treat binge eating disorder, and two other candidates that are part of supplemental filings for expanded indications. 

Cambridge, Mass.-based Blueprint Medicines Corp.’s price tag and label for Ayvakit (avapritinib) caused some chagrin on Wall Street as observers continued to weigh the drug’s odds against ripretinib, the competing drug for which Deciphera Pharmaceuticals Inc. awaits regulatory action.