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Blueprint Medicines (BPMC) Up More Than 30% YTD: Here's Why
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Shares of Blueprint Medicines Corporation (BPMC - Free Report) have surged 36.8% so far this year compared with the industry’s increase of 6.3%.
The company's lead pipeline candidate avapritinib, an inhibitor of KIT and PDGFRA proteins, is being evaluated in several late-stage studies for cancer indications. Blueprint Medicines is riding on the success of avapritinib as the candidate is nearing a potential FDA approval next year.
In August 2019, the FDA accepted the new drug application (NDA) for avapritinib to treat patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST), regardless of any prior therapy, and the fourth-line GIST. The FDA has set an action date of Feb 14, 2020 for both indications.
The marketing application for avapritinib in Europe to treat adult patients with PDGFRα D842V mutant GIST, regardless of any prior therapy and the fourth-line GIST, was validated by the European Medicines Agency (EMA) in July 2019.
Meanwhile, Blueprint Medicines is evaluating the safety and efficacy of avapritinib compared with Bayer’s (BAYRY - Free Report) Stivarga (regorafenib) in the phase III VOYAGER study for treating patients with third- and fourth-line GIST. The company plans to file a supplemental NDA for avapritinib to the FDA in the second half of 2020 for addressing the third-line GIST.
Other than GIST, Blueprint Medicines is pursuing a broad clinical development program for avapritinib across the advanced, indolent and smoldering forms of systemic mastocytosis (SM).
Earlier this month, the company announced encouraging initial data from the dose-finding part 1 of phase II PIONEER study on avapritinib for treating patients with indolent SM. The candidate was well-tolerated at all dose levels tested and no patient discontinued treatment due to adverse side effects.
Shares of the company rose substantially back then. The company plans to submit an NDA for avapritinib in the first quarter of 2020 to treat advanced SM indication.
A potential approval of the candidate for any of the above indications will be a significant boost to the company.
Apart from avapritinib, Blueprint Medicines has several promising pipeline candidates making a good progress.
Pralsetinib (formerly BLU-667) in being studied in the phase I/II ARROW study evaluating previously-treated patients with receptor tyrosine RET-fusion non-small cell lung cancer (NSCLC) and RET-mutant medullary thyroid carcinoma (MTC). The company plans to submit an NDA for pralsetinib in the first quarter of 2020 to treat NSCLC while the same for the MTC indication is expected to be filed in the first half of next year.
Other pipeline candidates in early-stage development are fisogatinib (formerly BLU-554) for hepatocellular carcinoma (HCC), a type of liver cancer, and BLU-782 for fibrodysplasia ossificans progressive (FOP), a severely disabling genetic disease caused by mutations in the ALK2 gene.
Notably, Blueprint Medicines has no approved product in its portfolio. Revenues generated by the company are drawn from its partnerships with Roche (RHHBY - Free Report) and CStone Pharmaceuticals for the development of its pipeline candidates. Therefore, a potential nod to avapritinib will lower the company’s heavy dependence on its partners for revenues and help boost its growth prospects.
Anika’s earnings estimates have moved 16% north for 2019 and 17.4% for 2020 over the past 60 days. The stock has soared 61.4% year to date.
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The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.
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Blueprint Medicines (BPMC) Up More Than 30% YTD: Here's Why
Shares of Blueprint Medicines Corporation (BPMC - Free Report) have surged 36.8% so far this year compared with the industry’s increase of 6.3%.
The company's lead pipeline candidate avapritinib, an inhibitor of KIT and PDGFRA proteins, is being evaluated in several late-stage studies for cancer indications. Blueprint Medicines is riding on the success of avapritinib as the candidate is nearing a potential FDA approval next year.
In August 2019, the FDA accepted the new drug application (NDA) for avapritinib to treat patients with PDGFRA Exon 18 mutant gastrointestinal stromal tumors (GIST), regardless of any prior therapy, and the fourth-line GIST. The FDA has set an action date of Feb 14, 2020 for both indications.
The marketing application for avapritinib in Europe to treat adult patients with PDGFRα D842V mutant GIST, regardless of any prior therapy and the fourth-line GIST, was validated by the European Medicines Agency (EMA) in July 2019.
Meanwhile, Blueprint Medicines is evaluating the safety and efficacy of avapritinib compared with Bayer’s (BAYRY - Free Report) Stivarga (regorafenib) in the phase III VOYAGER study for treating patients with third- and fourth-line GIST. The company plans to file a supplemental NDA for avapritinib to the FDA in the second half of 2020 for addressing the third-line GIST.
Other than GIST, Blueprint Medicines is pursuing a broad clinical development program for avapritinib across the advanced, indolent and smoldering forms of systemic mastocytosis (SM).
Earlier this month, the company announced encouraging initial data from the dose-finding part 1 of phase II PIONEER study on avapritinib for treating patients with indolent SM. The candidate was well-tolerated at all dose levels tested and no patient discontinued treatment due to adverse side effects.
Shares of the company rose substantially back then. The company plans to submit an NDA for avapritinib in the first quarter of 2020 to treat advanced SM indication.
A potential approval of the candidate for any of the above indications will be a significant boost to the company.
Apart from avapritinib, Blueprint Medicines has several promising pipeline candidates making a good progress.
Pralsetinib (formerly BLU-667) in being studied in the phase I/II ARROW study evaluating previously-treated patients with receptor tyrosine RET-fusion non-small cell lung cancer (NSCLC) and RET-mutant medullary thyroid carcinoma (MTC). The company plans to submit an NDA for pralsetinib in the first quarter of 2020 to treat NSCLC while the same for the MTC indication is expected to be filed in the first half of next year.
Other pipeline candidates in early-stage development are fisogatinib (formerly BLU-554) for hepatocellular carcinoma (HCC), a type of liver cancer, and BLU-782 for fibrodysplasia ossificans progressive (FOP), a severely disabling genetic disease caused by mutations in the ALK2 gene.
Notably, Blueprint Medicines has no approved product in its portfolio. Revenues generated by the company are drawn from its partnerships with Roche (RHHBY - Free Report) and CStone Pharmaceuticals for the development of its pipeline candidates. Therefore, a potential nod to avapritinib will lower the company’s heavy dependence on its partners for revenues and help boost its growth prospects.
Blueprint Medicines Corporation Price
Blueprint Medicines Corporation price | Blueprint Medicines Corporation Quote
Zacks Rank & Key Pick
Blueprint Medicines currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Anika Therapeutics Inc. (ANIK - Free Report) , which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have moved 16% north for 2019 and 17.4% for 2020 over the past 60 days. The stock has soared 61.4% year to date.
Breakout Biotech Stocks with Triple-Digit Profit Potential
The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +98%, +119% and +164% in as little as 1 month. The stocks in this report could perform even better.
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