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Shares of Blueprint Medicines Corporation BPMC have rallied 41.7% in the past three months compared with the industry’s increase of 9.6%.
Last week, the company submitted a supplemental new drug application to the FDA for its lead drug, Ayvakit (avapritinib), for the treatment of adult patients with advanced systemic mastocytosis (“SM”), a rare, debilitating disease. Blueprint Medicines is also developing Ayvakit for the treatment of indolent SM.
Notably, in September 2020, the company announced positive top-line data from the phase I EXPLORER and the phase II PATHFINDER studies, which evaluated Ayvakit for advanced SM. Shares of the company rose significantly after the data release.
Ayvakit was approved by the FDA in January 2020 as a treatment of unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation including PDGFRA D842V mutations in adults. Following this nod, Ayvakit became the first precision therapy to be approved by the FDA for treating genomically defined patients with gastrointestinal stromal tumors (“GIST”), a rare form of cancer.
In September 2020, the European Commission granted conditional marketing authorization to Ayvakyt as a monotherapy for the treatment of adult patients with unresectable/metastatic GIST, harboring the PDGFRA D842V mutation. The drug is marketed under the trade name Ayvakit in the United States.
Ayvakit/Ayvakyt recorded sales of $15.3 million in the first nine months of 2020. A potential approval for the SM indication should drive its sales prospects as well as the company’s stock in the future quarters.
Meanwhile, in December 2020, the FDA approved Blueprint Medicines' second precision medicine Gavreto (pralsetinib) for the treatment of patients with advanced/metastatic rearranged during transfection (“RET”)-mutant and RET fusion-positive thyroid cancer.
Gavreto is a once-daily oral precision therapy that selectively inhibits RET-altered cancers. In September 2020, the FDA approved Gavreto for the treatment of adults with metastatic RET fusion-positive non-small-cell lung cancer (“NSCLC”).
The European Medicines Agency has also validated the marketing application for Gavreto for the treatment of RET fusion-positive NSCLC. A potential nod in EU should boost the drug's growth prospects.
We remind investors that Blueprint Medicines is co-developing Gavreto with Genentech, a wholly owned subsidiary Roche RHHBY, for addressing various types of RET-altered thyroid cancers as well as other cancer indications.
Both companies will co-commercialize Gavreto in the United States while Roche alone will commercialize the drug in other countries.
Blueprint Medicines is riding on the success of Ayvakit as the drug is nearing a potential label expansion approval in 2021. The fact that Gavreto is also approved for two types of cancer indications is an added positive for the company. However, any regulatory setback for Ayvakit or Gavreto could hurt the stock in the days ahead.
Moreover, competition remains stiff as Deciphera Pharmaceuticals’ DCPH Qinlock (ripretinib) was approved by the FDA in May 2020 to treat adult patients with advanced GIST who have already received prior treatment with three or more kinase inhibitors including Novartis’ NVS Gleevec (imatinib).
Blueprint Medicines Corporation Price
Blueprint Medicines Corporation price | Blueprint Medicines Corporation Quote
Blueprint Medicines currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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