Eisai and Biogen’s Alzheimer’s drug get positive CHMP opinion Investing.com
TOKYO and CAMBRIDGE, Mass. – Company Eisai Co., Ltd. (TYO:) and Biogen Inc. (NASDAQ:) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of their Alzheimer’s drug, lecanemab. This recommendation is for the treatment of adult patients with moderate disability and mild dementia due to Alzheimer’s disease, especially those who are carriers or heterozygotes of the apolipoprotein E ε4 gene with confirmed amyloid pathology.
This positive opinion from the CHMP comes after Eisai requested a re-examination of the previous negative opinion issued in July 2024. The European Commission is expected to make a final decision on the application for marketing authorization for lecanemab within 67 days from the CHMP’s acceptance. the idea.
Lecanemab works by targeting and reducing amyloid-beta aggregates in the brain, which are associated with Alzheimer’s disease. The drug has been approved in several countries including the United States, Japan, and Great Britain and is under review in 17 other countries.
The CHMP recommendation is based primarily on Phase 3 data from Eisai’s global study of Clarity AD, which met its primary endpoint and all key secondary endpoints with statistically significant results. In the study, lecanemab reduced clinical decline by 31% at 18 months compared to placebo. The most common adverse reactions reported were infusion-related reactions, brain swelling (ARIA-H), headache, and ARIA-E.
Alzheimer’s disease affects approximately 6.9 million people in Europe, a number expected to nearly double by 2050. The progression of the disease presents increasing challenges for those living with it and their care partners, highlighting the urgency for new treatments.
Eisai leads the development and regulatory distribution of lecanemab worldwide, so both Eisai and Biogen are co-commercializing and co-promoting the product. Eisai has the final authority to make decisions.
This news is based on a press release and reflects the current stage of the regulatory review process for lecanemab in the European Union.
In other recent news, Biogen has been the focus of many financial firms’ analysis due to its third quarter performance and future projections. Citi initiated coverage on Biogen with a neutral rating and a $190 price target, indicating a cautious stance on the biotech company’s financial outlook. The company admitted that there is likely to be a stabilization of income from legacy franchises and the introduction of new products, despite the decrease in income expected in 2024-2026.
Several financial firms, including TD Cowen, Oppenheimer, and RBC Capital, adjusted their price estimates for Biogen, while maintaining a positive rating. TD Cowen projects a return to growth for Biogen, driven by the performance of its drugs Leqembi and Skyclarys, with a 2% revenue CAGR and a 10% EPS CAGR through 2030. Oppenheimer also lowered its price target to $255 from $270 while maintaining Outperform. average, citing Biogen’s strong quarterly results, which beat expectations.
RBC Capital Markets lowered its price target from $269 to $260, while maintaining an Outperform rating. The firm noted positive developments such as Leqembi’s international operations, improved operational efficiency, and focus on the product pipeline. However, Morgan Stanley (NYSE: ) downgraded Biogen from Overweight to Equalweight due to the disappointing launch of Leqembi and lowered its price target to $204 from $285.
Despite facing challenges, Biogen is making progress on its strategic goals, focusing on sustainable growth and pipeline expansion. The company’s largest potential pipeline sales are estimated at $14 billion, including dapirolizumab and felzartamab. These recent developments highlight Biogen’s commitment to strategic growth and new product development.
InvestingPro Insights
As Biogen (NASDAQ:BIIB) receives positive news regarding the potential approval of lecanemab in Europe, it’s worth checking out key financial metrics and insights from InvestingPro.
According to InvestingPro data, Biogen’s market capitalization reaches $24.52 billion, indicating its significant presence in the biotechnology sector. The company’s P/E ratio of 15.18 suggests a moderate valuation compared to other industry peers.
InvestingPro Tips notes that Biogen’s net income is expected to grow this year, which may be due in part to the potential success of lecanemab and other drugs in its launch. In addition, 10 analysts have revised their ratings upward, indicating growing confidence in the company’s financial prospects.
Interestingly, InvestingPro Tips also points out that Biogen stock is trading near its 52-week high and the RSI suggests it may be in oversold territory. This could present an opportunity for investors who believe in the company’s long-term potential, especially given the positive development with lecanemab.
It’s worth noting that Biogen doesn’t pay dividends to shareholders, instead reinvesting profits into research and development of new treatments like lecanemab. This strategy is in line with the company’s focus on developing a challenge in the field of neurodegenerative diseases.
For investors looking for a more comprehensive analysis, InvestingPro offers additional tips and insights beyond what is discussed here. In fact, there are 8 other InvestingPro Tips available at Biogen, which provide a deeper understanding of the company’s financial health and market conditions.
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