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AstraZeneca (AZN) Rare Disorder Drug Koselugo Gets EU Nod
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AstraZeneca (AZN - Free Report) announced that the European Commission has granted conditional approval to its MEK 1/2 inhibitor, Koselugo (selumetinib). Koselugo has been approved for the treatment of pediatric patients (aged 3 and above) with neurofibromatosis type 1 (NF1) related plexiform neurofibromas (PN), a rare and debilitating genetic condition.
Koselugo is the first medicine approved in Europe for NF1 related PN. The approval was expected as in April the Committee for Medicinal Products for Human Use of the European Medicines Agency had given a positive opinion recommending approval of the drug. The approval was based on data from the SPRINT Stratum 1 phase II study testing Koselugo as an oral monotherapy in pediatric patients aged two years or older with inoperable NF1-related PN
Data from the study demonstrated that Koselugo shrank tumor size in some children, reduced pain and improved quality of life. In the study, Koselugo, as twice-daily oral monotherapy, shrank NF1-related PNs in 66% of the patients. The study was sponsored by the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP).
This year so far, AstraZeneca’s shares have risen 15.8% compared with an increase of 7.9% for the industry.
Image Source: Zacks Investment Research
Koselugo was approved by the FDA in April 2020. The drug generated sales of $21 million in the first quarter of 2021. Sales could be higher in the future quarters of 2021 following the approval received in Europe.
Notably, AstraZeneca and Merck (MRK - Free Report) are jointly developing and commercializing Koselugo globally for multiple cancer types, per a deal signed in July 2017. AstraZeneca records product sales of Koselugo while Merck books half the profits.
Meanwhile, per the same deal, the companies also share development and commercialization of successful PARP inhibitor, Lynparza.
Some better-ranked drug/biotech stocks are BioNTech (BNTX - Free Report) and Bayer (BAYRY - Free Report) While BioNTech sports a Zacks Rank of 1, Bayer has a Zacks Rank of 2 (Buy).
Estimates for BioNTech 2021 earnings have gone up from $18.39 per share to $30.85 per share while that for 2022 have risen from $7.55 per share to $25.20 per share over the past 60 days The stock has risen 190.1% this year so far.
Estimates for Bayer’s 2021 earnings have gone up from $1.74 per share to $1.81per share while that for 2022 have risen from $1.89 per share to $2.00 per share over the past 60 days. Shares are up 3.5% this year so far.
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AstraZeneca (AZN) Rare Disorder Drug Koselugo Gets EU Nod
AstraZeneca (AZN - Free Report) announced that the European Commission has granted conditional approval to its MEK 1/2 inhibitor, Koselugo (selumetinib). Koselugo has been approved for the treatment of pediatric patients (aged 3 and above) with neurofibromatosis type 1 (NF1) related plexiform neurofibromas (PN), a rare and debilitating genetic condition.
Koselugo is the first medicine approved in Europe for NF1 related PN. The approval was expected as in April the Committee for Medicinal Products for Human Use of the European Medicines Agency had given a positive opinion recommending approval of the drug. The approval was based on data from the SPRINT Stratum 1 phase II study testing Koselugo as an oral monotherapy in pediatric patients aged two years or older with inoperable NF1-related PN
Data from the study demonstrated that Koselugo shrank tumor size in some children, reduced pain and improved quality of life. In the study, Koselugo, as twice-daily oral monotherapy, shrank NF1-related PNs in 66% of the patients. The study was sponsored by the National Cancer Institute (NCI) Cancer Therapy Evaluation Program (CTEP).
This year so far, AstraZeneca’s shares have risen 15.8% compared with an increase of 7.9% for the industry.
Koselugo was approved by the FDA in April 2020. The drug generated sales of $21 million in the first quarter of 2021. Sales could be higher in the future quarters of 2021 following the approval received in Europe.
Notably, AstraZeneca and Merck (MRK - Free Report) are jointly developing and commercializing Koselugo globally for multiple cancer types, per a deal signed in July 2017. AstraZeneca records product sales of Koselugo while Merck books half the profits.
Meanwhile, per the same deal, the companies also share development and commercialization of successful PARP inhibitor, Lynparza.
AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Some better-ranked drug/biotech stocks are BioNTech (BNTX - Free Report) and Bayer (BAYRY - Free Report) While BioNTech sports a Zacks Rank of 1, Bayer has a Zacks Rank of 2 (Buy).
Estimates for BioNTech 2021 earnings have gone up from $18.39 per share to $30.85 per share while that for 2022 have risen from $7.55 per share to $25.20 per share over the past 60 days The stock has risen 190.1% this year so far.
Estimates for Bayer’s 2021 earnings have gone up from $1.74 per share to $1.81per share while that for 2022 have risen from $1.89 per share to $2.00 per share over the past 60 days. Shares are up 3.5% this year so far.
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 +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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