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Will Ayvakit Aid Blueprint Medicines (BPMC) Amid Rivalry?
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Blueprint Medicines Corporation (BPMC - Free Report) has made steady progress with its lead drug, Ayvakit (avapritinib), which is approved by the FDA for treating adult patients with unresectable or metastatic gastrointestinal stromal tumors (“GIST”), harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
The European Commission has granted conditional marketing authorization to Ayvakyt (brand name of Ayvakit in Europe) as a monotherapy for the treatment of adult patients with unresectable/metastatic GIST, harboring the PDGFRA D842V mutation.
Ayvakit/Ayvakyt has also been approved for additional indications.
In June 2021, the FDA approved Ayvakit for treating advanced systemic mastocytosis (“SM”), a rare and debilitating disease.
In March, the European Commission approved Ayvakyt 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.
In August 2022, BPMC announced positive top-line data from part 2 of the PIONEER study, which evaluated Ayvakit for treating patients with non-advanced SM.
A supplemental new drug application (sNDA) seeking approval of Ayvakit for treating non-advanced SM, is expected to be submitted in the fourth quarter of 2022.
The steady performance of Ayvakit, along with encouraging pipeline progress, has maintained momentum for BPMC.
However, Ayvakit faces competition from Deciphera Pharmaceuticals' (DCPH - Free Report) Qinlock (ripretinib), which is approved for the treatment of fourth-line GIST. The European Commission approved Qinlock for the same indication.
Deciphera’s sole-marketed drug, Qinlock, holds great potential. DCPH is also working to expand the label of Qinlock for the larger commercial opportunity in GIST.
This apart, investors remain upbeat about Blueprint Medicines’ lucrative collaboration deals that help the company to drive its revenue stream and enhance its financial position.
Blueprint Medicines has collaborations and license agreements with Roche Holding AG (RHHBY - Free Report) , Zai Lab Limited (ZLAB - Free Report) and several other companies for the development/commercialization of its drugs and drug candidates.
Blueprint Medicines is co-developing a cancer drug, Gavreto (pralsetinib), with Roche for treating patients with various types of RET-altered thyroid cancers and other solid tumors.
In July 2021, Blueprint Medicines transferred the responsibilities of booking U.S. product sales of Gavreto to RHHBY.
In November 2021, Blueprint Medicines entered into a license agreement with Zai Lab for the development/commercialization of BLU-945 and BLU-701 for the treatment of patients with EGFR-driven NSCLC in Greater China.
With acute competition lingering in the targeted cancer space, such lucrative deals are likely to enable BPMC to diversify its portfolio and overcome these challenges.
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Will Ayvakit Aid Blueprint Medicines (BPMC) Amid Rivalry?
Blueprint Medicines Corporation (BPMC - Free Report) has made steady progress with its lead drug, Ayvakit (avapritinib), which is approved by the FDA for treating adult patients with unresectable or metastatic gastrointestinal stromal tumors (“GIST”), harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.
The European Commission has granted conditional marketing authorization to Ayvakyt (brand name of Ayvakit in Europe) as a monotherapy for the treatment of adult patients with unresectable/metastatic GIST, harboring the PDGFRA D842V mutation.
Ayvakit/Ayvakyt has also been approved for additional indications.
In June 2021, the FDA approved Ayvakit for treating advanced systemic mastocytosis (“SM”), a rare and debilitating disease.
In March, the European Commission approved Ayvakyt 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.
In August 2022, BPMC announced positive top-line data from part 2 of the PIONEER study, which evaluated Ayvakit for treating patients with non-advanced SM.
A supplemental new drug application (sNDA) seeking approval of Ayvakit for treating non-advanced SM, is expected to be submitted in the fourth quarter of 2022.
The steady performance of Ayvakit, along with encouraging pipeline progress, has maintained momentum for BPMC.
However, Ayvakit faces competition from Deciphera Pharmaceuticals' (DCPH - Free Report) Qinlock (ripretinib), which is approved for the treatment of fourth-line GIST. The European Commission approved Qinlock for the same indication.
Deciphera’s sole-marketed drug, Qinlock, holds great potential. DCPH is also working to expand the label of Qinlock for the larger commercial opportunity in GIST.
This apart, investors remain upbeat about Blueprint Medicines’ lucrative collaboration deals that help the company to drive its revenue stream and enhance its financial position.
Blueprint Medicines has collaborations and license agreements with Roche Holding AG (RHHBY - Free Report) , Zai Lab Limited (ZLAB - Free Report) and several other companies for the development/commercialization of its drugs and drug candidates.
Blueprint Medicines is co-developing a cancer drug, Gavreto (pralsetinib), with Roche for treating patients with various types of RET-altered thyroid cancers and other solid tumors.
In July 2021, Blueprint Medicines transferred the responsibilities of booking U.S. product sales of Gavreto to RHHBY.
In November 2021, Blueprint Medicines entered into a license agreement with Zai Lab for the development/commercialization of BLU-945 and BLU-701 for the treatment of patients with EGFR-driven NSCLC in Greater China.
With acute competition lingering in the targeted cancer space, such lucrative deals are likely to enable BPMC to diversify its portfolio and overcome these challenges.