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Blueprint (BPMC) Gets EC Nod for Ayvakit Expanded Use, Stock Up
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Blueprint Medicine (BPMC - Free Report) announced that the European Commission (EC) has approved the label expansion of Ayvakit (avapritinib) to include the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment.
Following the EC approval, Ayvakit, a kinase inhibitor, became the first and only approved therapy for ISM patients in the EU.
Blueprint plans to initiate its first commercial launch of Ayvakit for this expanded indication in Germany, followed by additional markets based on local healthcare technology assessment and reimbursement process timelines.
Notably, in May 2023, Blueprint received regulatory approval, expanding Ayvakit’s label to include ISM treatment in the United States. Ayvakit is now approved for three indications, both in the United States and EU, adults with PDGFRA Exon 18 mutant gastrointestinal stromal tumors, adults with advanced systemic mastocytosis and adults with ISM.
Blueprint’s stock gained 5% in the last trading session as the investors cheered the label expansion of Ayvakit in the EU which is expected to further drive up revenues for the company. Year to date, the shares of BPMC have surged 94% against the industry’s 19.9% decline.
Image Source: Zacks Investment Research
We would like to remind the investors that in November 2023, the advisory committee of the EU regulatory body adopted a positive opinion, recommending the approval of Ayvakit in ISM. The decision of the EU regulatory body approving Ayvakit for the ISM indication follows the positive recommendation by the advisory committee.
The approval for the label expansion of Ayvakit in the EU was based on positive data from the company’s PIONEER study– the largest study ever conducted in ISM. In the study, it was observed that treatment with Ayvakit resulted in clinically meaningful improvements compared to placebo in the primary and all key secondary endpoints, including overall symptoms and measures of mast cell burden.
Additionally, Ayvakit was found to be generally well-tolerated with a favorable safety profile. Adverse events (AEs) related to treatment were mild in severity. The most common AEs were flushing, edema, increased blood alkaline phosphate and insomnia.
Systemic Mastocytosis (SM) is a rare disease that is caused by KIT D816V mutation in most cases. It is a result of abnormal growth of mast cells in the human body resulting in chronic, severe, and often unprecedented symptoms in multiple organs. According to demographics, most patients suffer from non-advanced (indolent or smoldering) SM.
Blueprint Medicines Corporation Price and Consensus
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. In the year so far, shares of PBYI have lost 11.6%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 3 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 16 cents. In the year so far, shares of ADMA have lost 3.6%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. In the year so far, shares of AGEN have plunged 66.7%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.
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Blueprint (BPMC) Gets EC Nod for Ayvakit Expanded Use, Stock Up
Blueprint Medicine (BPMC - Free Report) announced that the European Commission (EC) has approved the label expansion of Ayvakit (avapritinib) to include the treatment of adult patients with indolent systemic mastocytosis (ISM) with moderate to severe symptoms inadequately controlled on symptomatic treatment.
Following the EC approval, Ayvakit, a kinase inhibitor, became the first and only approved therapy for ISM patients in the EU.
Blueprint plans to initiate its first commercial launch of Ayvakit for this expanded indication in Germany, followed by additional markets based on local healthcare technology assessment and reimbursement process timelines.
Notably, in May 2023, Blueprint received regulatory approval, expanding Ayvakit’s label to include ISM treatment in the United States. Ayvakit is now approved for three indications, both in the United States and EU, adults with PDGFRA Exon 18 mutant gastrointestinal stromal tumors, adults with advanced systemic mastocytosis and adults with ISM.
Blueprint’s stock gained 5% in the last trading session as the investors cheered the label expansion of Ayvakit in the EU which is expected to further drive up revenues for the company. Year to date, the shares of BPMC have surged 94% against the industry’s 19.9% decline.
Image Source: Zacks Investment Research
We would like to remind the investors that in November 2023, the advisory committee of the EU regulatory body adopted a positive opinion, recommending the approval of Ayvakit in ISM. The decision of the EU regulatory body approving Ayvakit for the ISM indication follows the positive recommendation by the advisory committee.
The approval for the label expansion of Ayvakit in the EU was based on positive data from the company’s PIONEER study– the largest study ever conducted in ISM. In the study, it was observed that treatment with Ayvakit resulted in clinically meaningful improvements compared to placebo in the primary and all key secondary endpoints, including overall symptoms and measures of mast cell burden.
Additionally, Ayvakit was found to be generally well-tolerated with a favorable safety profile. Adverse events (AEs) related to treatment were mild in severity. The most common AEs were flushing, edema, increased blood alkaline phosphate and insomnia.
Systemic Mastocytosis (SM) is a rare disease that is caused by KIT D816V mutation in most cases. It is a result of abnormal growth of mast cells in the human body resulting in chronic, severe, and often unprecedented symptoms in multiple organs. According to demographics, most patients suffer from non-advanced (indolent or smoldering) SM.
Blueprint Medicines Corporation Price and Consensus
Blueprint Medicines Corporation price-consensus-chart | Blueprint Medicines Corporation Quote
Zacks Rank and Stocks to Consider
Blueprint currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks worth mentioning are Puma Biotechnology, Inc. (PBYI - Free Report) , ADMA Biologics (ADMA - Free Report) and Agenus (AGEN - Free Report) . While PBYI sports a Zacks Rank #1 (Strong Buy), ADMA and AGEN carry a Zacks Rank #2 (Buy) each at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 30 days, the Zacks Consensus Estimate for Puma Biotech’s 2023 earnings per share (EPS) has remained constant at 72 cents. During the same time frame, the consensus estimate for Puma Biotech’s 2024 EPS has increased from 62 cents to 64 cents. In the year so far, shares of PBYI have lost 11.6%.
PBYI’s earnings beat estimates in three of the last four quarters while missing on one occasion, delivering a four-quarter average earnings surprise of 76.55%.
In the past 30 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has remained constant at 3 cents. The consensus estimate for ADMA Biologics’ 2024 EPS is pegged at 16 cents. In the year so far, shares of ADMA have lost 3.6%.
ADMA beat estimates in three of the trailing four quarters and matched in one, delivering an average earnings surprise of 63.57%.
In the past 30 days, the Zacks Consensus Estimate for Agenus’ 2023 loss per share has remained constant at 63 cents. During the same time frame, the consensus estimate for Agenus’ 2024 loss per share has remained constant at 45 cents. In the year so far, shares of AGEN have plunged 66.7%.
AGEN beat estimates in one of the trailing four quarters, matching in one and missing the mark on the other two occasions, delivering an average earnings surprise of 0.49%.