Shares of Blueprint Medicines Corp. (BPMC) are down more than 30 percent from their yearly high and currently trade around $64.
The Company’s first medicine AYVAKIT won the FDA approval for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations in January of this year. The active ingredient in AYVAKIT is avapritinib.
Blueprint Medicines has a couple of Avapritinib-related events to watch out for in the coming months.
— A phase III trial of Avapritinib in third-line GIST, dubbed VOYAGER, is underway, with top-line data expected in the second quarter of 2020.
— The FDA decision on Avapritinib for the treatment of adults with fourth-line gastrointestinal stromal tumor (GIST) is expected by May 14, 2020.
— A supplemental new drug application for Avapritinib for third-line GIST is planned for submission in the second half of 2020.
— A supplemental NDA seeking approval of Avapritinib for advanced systemic mastocytosis is expected to be submitted to the FDA in the second half of 2020.
— A phase II clinical trial of Avapritinib in patients with indolent systemic mastocytosis, dubbed PIONEER, is underway. The initial data from Part 1 of the PIONEER trial presented last December were encouraging. Updated data from Part 1 of the PIONEER trial is expected this quarter.
Next up in the pipeline is Pralsetinib (BLU-667) for the treatment of RET fusion-positive non-small cell lung cancer. The Company has initiated a rolling NDA submission to the FDA for Pralsetinib for the treatment of RET fusion-positive NSCLC, and the submission is expected to be completed this quarter.
A New Drug Application for Pralsetinib for previously treated RET-mutant medullary thyroid cancer is expected to be filed with the FDA in the second quarter of 2020.
The Company has plans to seek approval of Pralsetinib for RET fusion-positive NSCLC in Europe in the second quarter of 2020.
A phase III trial of Pralsetinib in first-line RET-mutant medullary thyroid cancer is expected to be initiated in the second half of 2020.
The Company is slated to report its fourth-quarter and full-year 2019 financial results and provide a corporate update tomorrow (Feb.13, 2020).
BPMC has traded in a range of $60.60 to $102.98 in the last 1 year.
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