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Biogen (BIIB) to Stop Selling Alzheimer's Disease Drug Aduhelm
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Biogen Inc. (BIIB - Free Report) announced plans to reprioritize its resources in Alzheimer’s disease (AD). It intends to advance the new Alzheimer’s drug Leqembi (lecanemab-irmb) and to accelerate the development of new treatment modalities.
Alzheimer's is a progressive, fatal disease of the brain characterized by a decline in memory, language and other thinking skills, as well as changes in mood and behavior.
As part of this reprioritization plan, Biogen will henceforth stop the development and commercialization of its controversial AD drug, Aduhelm (aducanumab-avwa), which was approved by the FDA on an accelerated basis in June 2021.
The regulatory body approved Aduhelm despite an FDA advisory committee voting against its approval due to mixed outcomes data from the ENGAGE and EMERGE phase III studies. All these issues affected demand, patient access and reimbursement for Aduhelm, which resulted in a slow launch.
Aduhelm was once seen as a potential blockbuster product. However, in April 2022, the Centers for Medicare & Medicaid Services (“CMS”) released its final National Coverage Determination (NCD) decision for the class of anti-amyloid antibodies approved by the FDA like Aduhelm. Per the final NCD decision, Medicare will cover FDA-approved drugs like Aduhelm only for patients enrolled in CMS-approved studies. The final NCD decision basically denied all Medicare beneficiaries access to Aduhelm, which reduced demand for the drug to a minimal level.
Along with the latest reprioritization, the company is also planning to terminate the phase IV post-marketing confirmatory ENVISION study, which was a requirement for an accelerated FDA approval of Aduhelm.
Biogen shares have plunged 14.2% in the past year compared with the industry’s decline of 12.7%.
Image Source: Zacks Investment Research
In January 2023, BIIB began a strategic review and sought potential partners to share the overall cost for Aduhelm studies to gain traditional approval for the drug.
However, Biogen failed to find strategic partners or external financing required for Aduhelm studies. The company will now return Aduhelm's rights to Neurimmune, from which it actually licensed the product. As a result of close-out costs for the Aduhelm program, BIIB recorded a one-time charge of around $60 million in the fourth quarter of 2023.
Though Aduhelm failed to live up to the expectation, the company believes that the findings from the studies on Aduhelm are likely to provide significant insight into the development of a new class of drugs for AD, including its ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113).
With this vision, Biogen is looking to advance a new AD drug, Leqembi/lecanemab, which gained full approval from the FDA for early Alzheimer’s disease in the United States and broad reimbursement from CMS in July 2023. It has the potential to generate blockbuster sales. Though Leqembi sales were slow in 2023, Biogen expects the same to start growing in 2024.
The European Medicines Agency is currently reviewing the marketing application seeking approval for Leqembi. In January 2024, Biogen’s Japanese partner for Leqembi, Eisai announced that the Scientific Advisory Group (SAG) will hold a meeting to discuss the marketing authorization application for Leqembi, which, in all probability, will be held by Mar 31, 2024.
Biogen has developed Leqembi in collaboration with Eisai, with the latter leading the clinical development and regulatory submissions. Though the companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority.
In the past 60 days, estimates for Repare Therapeutics’ 2024 loss per share have narrowed from $3.41 to $3.20. In the past year, shares of RPTX have declined 50.2%.
Earnings of Repare Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. RPTX delivered a four-quarter average earnings surprise of 28.10%.
In the past 60 days, estimates for Kodiak Sciences’ 2024 loss per share have narrowed from $3.70 to $3.68. In the past year, shares of KOD have plunged 52.7%.
Kodiak Sciences beat estimates in two of the last four quarters while missing the same on the remaining two occasions. KOD delivered a four-quarter average earnings surprise of 4.33%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 7.6%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.
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Biogen (BIIB) to Stop Selling Alzheimer's Disease Drug Aduhelm
Biogen Inc. (BIIB - Free Report) announced plans to reprioritize its resources in Alzheimer’s disease (AD). It intends to advance the new Alzheimer’s drug Leqembi (lecanemab-irmb) and to accelerate the development of new treatment modalities.
Alzheimer's is a progressive, fatal disease of the brain characterized by a decline in memory, language and other thinking skills, as well as changes in mood and behavior.
As part of this reprioritization plan, Biogen will henceforth stop the development and commercialization of its controversial AD drug, Aduhelm (aducanumab-avwa), which was approved by the FDA on an accelerated basis in June 2021.
The regulatory body approved Aduhelm despite an FDA advisory committee voting against its approval due to mixed outcomes data from the ENGAGE and EMERGE phase III studies. All these issues affected demand, patient access and reimbursement for Aduhelm, which resulted in a slow launch.
Aduhelm was once seen as a potential blockbuster product. However, in April 2022, the Centers for Medicare & Medicaid Services (“CMS”) released its final National Coverage Determination (NCD) decision for the class of anti-amyloid antibodies approved by the FDA like Aduhelm. Per the final NCD decision, Medicare will cover FDA-approved drugs like Aduhelm only for patients enrolled in CMS-approved studies. The final NCD decision basically denied all Medicare beneficiaries access to Aduhelm, which reduced demand for the drug to a minimal level.
Along with the latest reprioritization, the company is also planning to terminate the phase IV post-marketing confirmatory ENVISION study, which was a requirement for an accelerated FDA approval of Aduhelm.
Biogen shares have plunged 14.2% in the past year compared with the industry’s decline of 12.7%.
In January 2023, BIIB began a strategic review and sought potential partners to share the overall cost for Aduhelm studies to gain traditional approval for the drug.
However, Biogen failed to find strategic partners or external financing required for Aduhelm studies. The company will now return Aduhelm's rights to Neurimmune, from which it actually licensed the product. As a result of close-out costs for the Aduhelm program, BIIB recorded a one-time charge of around $60 million in the fourth quarter of 2023.
Though Aduhelm failed to live up to the expectation, the company believes that the findings from the studies on Aduhelm are likely to provide significant insight into the development of a new class of drugs for AD, including its ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113).
With this vision, Biogen is looking to advance a new AD drug, Leqembi/lecanemab, which gained full approval from the FDA for early Alzheimer’s disease in the United States and broad reimbursement from CMS in July 2023. It has the potential to generate blockbuster sales. Though Leqembi sales were slow in 2023, Biogen expects the same to start growing in 2024.
The European Medicines Agency is currently reviewing the marketing application seeking approval for Leqembi. In January 2024, Biogen’s Japanese partner for Leqembi, Eisai announced that the Scientific Advisory Group (SAG) will hold a meeting to discuss the marketing authorization application for Leqembi, which, in all probability, will be held by Mar 31, 2024.
Biogen has developed Leqembi in collaboration with Eisai, with the latter leading the clinical development and regulatory submissions. Though the companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority.
Zacks Rank & Stocks to Consider
Biogen currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the healthcare sector are Repare Therapeutics Inc. (RPTX - Free Report) , Kodiak Sciences Inc. (KOD - Free Report) and Puma Biotechnology, Inc. (PBYI - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Repare Therapeutics’ 2024 loss per share have narrowed from $3.41 to $3.20. In the past year, shares of RPTX have declined 50.2%.
Earnings of Repare Therapeutics beat estimates in three of the last four quarters while missing the same on the remaining occasion. RPTX delivered a four-quarter average earnings surprise of 28.10%.
In the past 60 days, estimates for Kodiak Sciences’ 2024 loss per share have narrowed from $3.70 to $3.68. In the past year, shares of KOD have plunged 52.7%.
Kodiak Sciences beat estimates in two of the last four quarters while missing the same on the remaining two occasions. KOD delivered a four-quarter average earnings surprise of 4.33%.
In the past 60 days, estimates for Puma Biotechnology’s 2024 earnings per share have improved from 62 cents to 69 cents. In the past year, shares of PBYI have risen 7.6%.
Earnings of Puma Biotechnology beat estimates in three of the last four quarters while missing the same on the remaining occasion. PBYI delivered a four-quarter average earnings surprise of 76.55%.