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Blueprint Medicines (BPMC) Files Ayvakit sNDA for Indolent SM
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Blueprint Medicines Corporation (BPMC - Free Report) announced that it has submitted a supplemental new drug application to the FDA seeking label expansion of its lead drug, Ayvakit (avapritinib) for a new indication.
The company is seeking approval for Ayvakit for the treatment of adults with indolent systemic mastocytosis (SM), a rare disease. This marks the first regulatory submission for the given indication.
The sNDA was based on data from the registrational PIONEER study, which evaluated Ayvakit for the treatment of indolent SM.
In August 2022, BPMC announced top-line data from part 2 of the PIONEER study, which evaluated Ayvakit for treating indolent SM. Data from the same showed that treatment with Ayvakit led to clinically meaningful and highly significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and measures of mast cell burden.
Ayvakit had a favorable safety profile compared to the control arm.
The FDA has granted breakthrough therapy designation to Ayvakit for the treatment of moderate-to-severe indolent SM.
Shares of Blueprint Medicines have plunged 59.4% so far this year compared with the industry’s decline of 19.9%.
Image Source: Zacks Investment Research
In June 2021, the FDA approved Ayvakit for the treatment of adult patients with advanced SM, including aggressive SM, SM with an associated hematological neoplasm, as well as mast cell leukemia.
In March 2022, the European Commission (“EC”) approved Ayvakyt (brand name of Ayvakit in Europe) as a monotherapy for the treatment of adult patients with aggressive SM, including SM with an associated hematological neoplasm, as well as mast cell leukemia, after at least one systemic therapy.
Ayvakit was first approved for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (“GIST”), harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations in the United States in January 2020. The EC too has granted conditional marketing authorization to Ayvakyt as a monotherapy for the treatment of adult patients with unresectable/metastatic GIST harboring the PDGFRA D842V mutation.
In the first nine months of 2022, Ayvakit/Ayvakyt generated sales worth $80.9 million, reflecting a significant increase year over year. Potential label expansion into additional indications will make Ayvakit eligible for treating a broader patient population and is likely to drive sales further in the days ahead.
Zacks Rank & Stocks to Consider
Blueprint Medicines currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Syndax Pharmaceuticals, Inc. (SNDX - Free Report) , Immunocore Holdings plc (IMCR - Free Report) and Angion Biomedica Corp. . While Syndax Pharmaceuticals sports a Zacks Rank #1 (Strong Buy), Immunocore and Angion Biomedica carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Syndax Pharmaceuticals have narrowed 4.9% for 2022 and 10.1% for 2023 in the past 60 days.
Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average
Loss per share estimates for Immunocore have narrowed 39.7% for 2022 and 39.4% for 2023 in the past 60 days.
Earnings of Immunocore surpassed estimates in three of the trailing four quarters and missed the same on the remaining occasion. IMCR witnessed an earnings surprise of 68.34% on average.
Loss per share estimates for Angion Biomedica have narrowed 6.1% for 2022 and 3.9% for 2023 in the past 60 days.
Earnings of Angion Biomedica surpassed estimates in three of the trailing four quarters and missed the mark on the other occasion. ANGN witnessed an earnings surprise of 66.42% on average.
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Blueprint Medicines (BPMC) Files Ayvakit sNDA for Indolent SM
Blueprint Medicines Corporation (BPMC - Free Report) announced that it has submitted a supplemental new drug application to the FDA seeking label expansion of its lead drug, Ayvakit (avapritinib) for a new indication.
The company is seeking approval for Ayvakit for the treatment of adults with indolent systemic mastocytosis (SM), a rare disease. This marks the first regulatory submission for the given indication.
The sNDA was based on data from the registrational PIONEER study, which evaluated Ayvakit for the treatment of indolent SM.
In August 2022, BPMC announced top-line data from part 2 of the PIONEER study, which evaluated Ayvakit for treating indolent SM. Data from the same showed that treatment with Ayvakit led to clinically meaningful and highly significant improvements across the primary and all key secondary endpoints, including patient-reported symptoms and measures of mast cell burden.
Ayvakit had a favorable safety profile compared to the control arm.
The FDA has granted breakthrough therapy designation to Ayvakit for the treatment of moderate-to-severe indolent SM.
Shares of Blueprint Medicines have plunged 59.4% so far this year compared with the industry’s decline of 19.9%.
Image Source: Zacks Investment Research
In June 2021, the FDA approved Ayvakit for the treatment of adult patients with advanced SM, including aggressive SM, SM with an associated hematological neoplasm, as well as mast cell leukemia.
In March 2022, the European Commission (“EC”) approved Ayvakyt (brand name of Ayvakit in Europe) as a monotherapy for the treatment of adult patients with aggressive SM, including SM with an associated hematological neoplasm, as well as mast cell leukemia, after at least one systemic therapy.
Ayvakit was first approved for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumors (“GIST”), harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations in the United States in January 2020. The EC too has granted conditional marketing authorization to Ayvakyt as a monotherapy for the treatment of adult patients with unresectable/metastatic GIST harboring the PDGFRA D842V mutation.
In the first nine months of 2022, Ayvakit/Ayvakyt generated sales worth $80.9 million, reflecting a significant increase year over year. Potential label expansion into additional indications will make Ayvakit eligible for treating a broader patient population and is likely to drive sales further in the days ahead.
Zacks Rank & Stocks to Consider
Blueprint Medicines currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Syndax Pharmaceuticals, Inc. (SNDX - Free Report) , Immunocore Holdings plc (IMCR - Free Report) and Angion Biomedica Corp. . While Syndax Pharmaceuticals sports a Zacks Rank #1 (Strong Buy), Immunocore and Angion Biomedica carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss per share estimates for Syndax Pharmaceuticals have narrowed 4.9% for 2022 and 10.1% for 2023 in the past 60 days.
Earnings of Syndax Pharmaceuticals surpassed estimates in three of the trailing four quarters and met the same on the other occasion. SNDX witnessed an earnings surprise of 95.39% on average
Loss per share estimates for Immunocore have narrowed 39.7% for 2022 and 39.4% for 2023 in the past 60 days.
Earnings of Immunocore surpassed estimates in three of the trailing four quarters and missed the same on the remaining occasion. IMCR witnessed an earnings surprise of 68.34% on average.
Loss per share estimates for Angion Biomedica have narrowed 6.1% for 2022 and 3.9% for 2023 in the past 60 days.
Earnings of Angion Biomedica surpassed estimates in three of the trailing four quarters and missed the mark on the other occasion. ANGN witnessed an earnings surprise of 66.42% on average.