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Biotech Stock Roundup: BIIB's Drug Approval, ALXN Drug Label Expansion & More
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The biotech sector continues to be in focus with regular pipeline and regulatory updates. Drug approvals were in focus last week.
Recap of the Week’s Most Important Stories:
Biogen Gets Approval for Alzheimer’s Disease Treatment: Shares of biotech giant, Biogen (BIIB - Free Report) , surged after it won FDA approval for Aduhelm (aducanumab-avwa) as the first and only Alzheimer’s disease treatment, after a few setbacks. The drug was developed in collaboration with Japan-based Eisai. The agency has granted approval on an accelerated basis.
The approval was based on encouraging data from two phase III studies — EMERGE and ENGAGE — in patients with early stages of Alzheimer’s disease (mild cognitive impairment and mild dementia) with confirmed presence of amyloid pathology. Data from these studies showed that Aduhelm reduced amyloid beta plaques by 59-71% at 18 months of treatment. As part of the accelerated approval, Biogen will conduct a controlled trial to verify the clinical benefit of Aduhelm in patients with Alzheimer’s disease.
Alexion Gets FDA Nod for PNH Drug in Younger Age Group: Alexion Pharmaceuticals, Inc. announced that the FDA has approved the label expansion of long-acting C5 inhibitor, Ultomiris. The drug has been approved to include children (one month of age and older) and adolescents with paroxysmal nocturnal hemoglobinuria [PNH]).
This approval was based on interim phase III study results, which showed that Ultomiris was effective in achieving complete C5 complement inhibition through 26 weeks in children and adolescents up to 18 years of age. Importantly, Ultomiris had no reported treatment-related severe adverse events and no patient discontinued the treatment during the primary evaluation period or experienced breakthrough hemolysis, which can lead to disabling or potentially fatal blood clots.
bluebird Up as FDA Lifts Hold on Clinical Studies: Shares of bluebird bio (BLUE - Free Report) gained after it announced that the FDA lifted the clinical holds on the phase I/II HGB-206 and phase III HGB-210 studies of LentiGlobin for sickle cell disease (SCD) gene therapy (bb1111) in adult and pediatric patients with SCD. The agency also lifted its hold on the phase III Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies of betibeglogene autotemcel gene therapy (beti-cel or Zynteglo in the EU and the UK) for adult, adolescent and pediatric patients with transfusion-dependent β-thalassemia (TDT).
Consequently, the company can resume the studies. The studies were put on hold due to a reported Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML).
Incyte’s sNDA Review Gets FDA Extension: Incyte (INCY - Free Report) announced that the FDA has extended the review period for the supplemental New Drug Application (sNDA) for the label expansion of lead drug, Jakafi (ruxolitinib). The sNDA is seeking the label expansion of Jakafi for the treatment of adult and pediatric patients 12 years and older with steroid-refractory chronic graft-versus-host disease (GVHD). The new Prescription Drug User Fee Act (PDUFA) target action date is Sep 22, 2021.
The agency needs time to review additional data submitted by Incyte in response to its information request. The submission of the additional information has been determined by the FDA to constitute a major amendment to the sNDA, resulting in an extension of the PDUFA goal date by three months.
Argenx Regains Rights for Leukemia Candidate: argenx SE (ARGX - Free Report) announced that it will regain worldwide rights to its anti-CD70 antibody, cusatuzumab, from Cilag GmbH International. Cilag GmbH International is one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ - Free Report) .
Argenx and Janssen signed a collaboration and license agreement in 2018 to develop cusatuzumab to treat AML and myelodysplastic syndromes (MDS). Per the terms of the agreement, argenx received $300 million in an upfront payment, approximately $200 million in an equity investment from Johnson & Johnson Innovation, JJDC, Inc. (JJDC), and $25 million in milestone payments to date.
However, Janssen has decided to discontinue the collaboration agreement during a regularly scheduled steering committee meeting on Jun 4, 2021. The decision was based on Janssen's review of all available cusatuzumab data and in consideration of the evolving standard of care for the treatment of AML.
Consequently, argenx plans to evaluate options to enable a path forward. The ongoing phase Ib ELEVATE trial is evaluating cusatuzumab in combination with venetoclax and azacitidine in newly-diagnosed, elderly patients with AML.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Stay tuned for more pipeline and regulatory updates.
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The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Image: Bigstock
Biotech Stock Roundup: BIIB's Drug Approval, ALXN Drug Label Expansion & More
The biotech sector continues to be in focus with regular pipeline and regulatory updates. Drug approvals were in focus last week.
Recap of the Week’s Most Important Stories:
Biogen Gets Approval for Alzheimer’s Disease Treatment: Shares of biotech giant, Biogen (BIIB - Free Report) , surged after it won FDA approval for Aduhelm (aducanumab-avwa) as the first and only Alzheimer’s disease treatment, after a few setbacks. The drug was developed in collaboration with Japan-based Eisai. The agency has granted approval on an accelerated basis.
The approval was based on encouraging data from two phase III studies — EMERGE and ENGAGE — in patients with early stages of Alzheimer’s disease (mild cognitive impairment and mild dementia) with confirmed presence of amyloid pathology. Data from these studies showed that Aduhelm reduced amyloid beta plaques by 59-71% at 18 months of treatment. As part of the accelerated approval, Biogen will conduct a controlled trial to verify the clinical benefit of Aduhelm in patients with Alzheimer’s disease.
Biogen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Alexion Gets FDA Nod for PNH Drug in Younger Age Group: Alexion Pharmaceuticals, Inc. announced that the FDA has approved the label expansion of long-acting C5 inhibitor, Ultomiris. The drug has been approved to include children (one month of age and older) and adolescents with paroxysmal nocturnal hemoglobinuria [PNH]).
This approval was based on interim phase III study results, which showed that Ultomiris was effective in achieving complete C5 complement inhibition through 26 weeks in children and adolescents up to 18 years of age. Importantly, Ultomiris had no reported treatment-related severe adverse events and no patient discontinued the treatment during the primary evaluation period or experienced breakthrough hemolysis, which can lead to disabling or potentially fatal blood clots.
bluebird Up as FDA Lifts Hold on Clinical Studies: Shares of bluebird bio (BLUE - Free Report) gained after it announced that the FDA lifted the clinical holds on the phase I/II HGB-206 and phase III HGB-210 studies of LentiGlobin for sickle cell disease (SCD) gene therapy (bb1111) in adult and pediatric patients with SCD. The agency also lifted its hold on the phase III Northstar-2 (HGB-207) and Northstar-3 (HGB-212) studies of betibeglogene autotemcel gene therapy (beti-cel or Zynteglo in the EU and the UK) for adult, adolescent and pediatric patients with transfusion-dependent β-thalassemia (TDT).
Consequently, the company can resume the studies. The studies were put on hold due to a reported Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia (AML).
Incyte’s sNDA Review Gets FDA Extension: Incyte (INCY - Free Report) announced that the FDA has extended the review period for the supplemental New Drug Application (sNDA) for the label expansion of lead drug, Jakafi (ruxolitinib). The sNDA is seeking the label expansion of Jakafi for the treatment of adult and pediatric patients 12 years and older with steroid-refractory chronic graft-versus-host disease (GVHD). The new Prescription Drug User Fee Act (PDUFA) target action date is Sep 22, 2021.
The agency needs time to review additional data submitted by Incyte in response to its information request. The submission of the additional information has been determined by the FDA to constitute a major amendment to the sNDA, resulting in an extension of the PDUFA goal date by three months.
Argenx Regains Rights for Leukemia Candidate: argenx SE (ARGX - Free Report) announced that it will regain worldwide rights to its anti-CD70 antibody, cusatuzumab, from Cilag GmbH International. Cilag GmbH International is one of the Janssen Pharmaceutical Companies of Johnson & Johnson (JNJ - Free Report) .
Argenx and Janssen signed a collaboration and license agreement in 2018 to develop cusatuzumab to treat AML and myelodysplastic syndromes (MDS). Per the terms of the agreement, argenx received $300 million in an upfront payment, approximately $200 million in an equity investment from Johnson & Johnson Innovation, JJDC, Inc. (JJDC), and $25 million in milestone payments to date.
However, Janssen has decided to discontinue the collaboration agreement during a regularly scheduled steering committee meeting on Jun 4, 2021. The decision was based on Janssen's review of all available cusatuzumab data and in consideration of the evolving standard of care for the treatment of AML.
Consequently, argenx plans to evaluate options to enable a path forward. The ongoing phase Ib ELEVATE trial is evaluating cusatuzumab in combination with venetoclax and azacitidine in newly-diagnosed, elderly patients with AML.
Performance
Medical - Biomedical and Genetics Industry 5YR % Return
Medical - Biomedical and Genetics Industry 5YR % Return
The Nasdaq Biotechnology Index gained 5.02% in the last five trading sessions. Among the biotech giants, Biogen surged 48% during the period. Over the past six months, shares of Biogen have surged 60.44%. (See the last biotech stock roundup here: Biotech Stock Roundup: MRNA COVID-19 Vaccine Update, Drug Approvals for ALKS, MYOV & More).
What's Next in Biotech?
Stay tuned for more pipeline and regulatory updates.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Download FREE: How to Profit from Trillions on Spending for Infrastructure >>