Blueprint Medicines Corporation
BPMC
announced that the European Medicines Agency (“EMA”) has validated its Type II variation marketing authorization application seeking approval for its lead drug, Ayvakyt (avapritinib) for the treatment of advanced systemic mastocytosis (“SM”), a rare, debilitating disease.
Last month, the company submitted the Type II variation marketing authorization application for Ayvakyt to the EMA. Notably, the European Commission (“EC”) has granted an orphan medicinal product designation to Ayvakyt for the treatment of mastocytosis.
Please note that the EC has already granted a conditional marketing authorization to Ayvakyt as a monotherapy for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (“GIST”), harboring the PDGFRA D842V mutation. The drug is marketed under the trade name Ayvakit in the United States.
In February 2021, the FDA accepted Blueprint Medicines’ supplemental new drug application (sNDA) seeking approval of Ayvakit for treating advanced SM. With the FDA granting a priority review to the sNDA, a decision from the regulatory body is expected on Jun 16, 2021. Upon potential approval for the SM indication, the company plans to launch the drug in the first half of this year.
Shares of Blueprint Medicines have declined 17% so far this year against the
industry’s
increase of 3.1%.
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We remind investors that in December 2020, Blueprint Medicines submitted a supplemental new drug application to the FDA for Ayvakit for the treatment of adult patients with advanced SM.
Please note that Ayvakit was approved by the FDA for treating unresectable or metastatic GIST, harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations in adults in January 2020.
Ayvakit/Ayvakyt recorded sales of $21.2 million in 2020. A potential label expansion in other indications should drive sales in the days ahead.
Zacks Rank & Stocks to Consider
Blueprint Medicines currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the biotech sector include
Caladrius Biosciences, Inc.
CLBS
,
Repligen Corporation
RGEN
and
Nabriva
Therapeutics AG
NBRV
, all carrying a Zacks Rank #2 (Buy) at present. You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
Caladrius’ loss per share estimates have narrowed 15.3% for 2021 over the past 60 days. The stock has rallied 32.9% year to date.
Repligen’s earnings estimates have been revised 12.6% upward for 2021 over the past 60 days. The stock has risen 4.3% year to date.
Nabriva’s loss per share estimates have narrowed 8.9% for 2021 over the past 60 days.
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