Stock market today: S&P 500 extends monthly win streak despite Nvidia-led stumble
TOKYO/CAMBRIDGE - Eisai Co., Ltd. and Biogen Inc. (NASDAQ:BIIB) presented data on Wednesday showing their investigational subcutaneous autoinjector (SC-AI) for lecanemab-irmb (LEQEMBI) demonstrates comparable efficacy and safety to the intravenous formulation for early Alzheimer’s disease maintenance treatment. Eisai, a prominent player in the pharmaceuticals industry with a robust 78.6% gross profit margin and 6.4% revenue growth over the last twelve months, continues to strengthen its market position. InvestingPro analysis indicates the company is currently trading below its Fair Value.
The results, presented at the Alzheimer’s Association International Conference in Toronto, showed the 360 mg weekly SC-AI maintenance dose maintained clinical and biomarker benefits similar to biweekly IV dosing when administered after 18 months of initial treatment. With a beta of -0.18, Eisai’s stock movements often counter market trends, offering potential portfolio diversification benefits. InvestingPro subscribers can access 6 additional key insights about Eisai’s market position and growth prospects.
According to the presentation, the safety profile of the SC-AI maintenance dosing was consistent with IV maintenance therapy, with less than 1% systemic injection reactions compared to 26% with IV administration. No cases of ARIA-E (amyloid-related imaging abnormalities-edema) were observed among 49 patients treated with the 360 mg SC weekly maintenance for a mean of six months.
Human factors studies involving 110 participants demonstrated that 95% successfully administered the maintenance dose. In a separate device acceptability study with 126 participants, over 95% reported the SC-AI was easy to administer, with high satisfaction levels.
The companies are developing the SC-AI as a maintenance treatment option following 18 months of IV therapy. Eisai has also developed a 500 mg SC-AI for initiation dosing. The company maintains a strong financial health score of "GOOD" according to InvestingPro metrics, supporting its continued investment in innovative treatment solutions.
The U.S. Food and Drug Administration accepted Eisai’s Biologics License Application for the LEQEMBI subcutaneous autoinjector in January 2025 with a PDUFA action date set for August 31, 2025.
Lecanemab, which targets both amyloid-beta protofibrils and plaque, is currently approved in 46 countries with regulatory review ongoing in 11 others. Eisai serves as the lead for lecanemab development and regulatory submissions globally, with both companies co-commercializing the product.
The information in this article is based on a press release statement from Eisai and Biogen.
In other recent news, Eisai announced its fiscal year results, which matched expectations but revealed concerning forecasts for the upcoming year. The pharmaceutical company projected an operating profit of ¥54 billion, consistent with the previous year, but this figure is 16% below the consensus. Additionally, Eisai anticipates a decrease in its gross profit margin from 78.6% in the fiscal year ending March 2025 to 76.9% in the current year, which is lower than the Visible Alpha consensus estimate of 78.3%. This decline is attributed to the increasing sales proportion of its product, Leqembi. Eisai also provided guidance for current-year sales of ¥790 billion, which remains unchanged from last year, yet falls short of consensus expectations. These developments have led to a 5.5% drop in Eisai’s shares.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.