European Medicines Agency Delays Approval Decision For Biogen-Eisai Partnered Alzheimer's Drug Lecanemab
Portfolio Pulse from Vandana Singh
The European Medicines Agency (EMA) has postponed the Oral Explanation for Biogen Inc and Eisai Co Ltd's Alzheimer's drug, Lecanemab, due to procedural issues. This delay affects the drug's review process, initially expected to conclude by June 30, 2024. The postponement follows a recent court ruling impacting EMA's policy on managing conflicts of interest among its Scientific Advisory Groups. Despite the delay, an approval is still anticipated in the second half of 2024. BIIB shares dropped 1.10% following the news.
March 22, 2024 | 5:44 pm
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Biogen Inc faces a delay in the EMA approval process for its Alzheimer's drug Lecanemab, partnered with Eisai, due to procedural issues. Shares fell 1.10% following the announcement.
The delay in the EMA approval process for Lecanemab directly impacts Biogen's potential revenue and market positioning for this drug. The immediate negative reaction in stock price reflects investor concerns over the delay.
CONFIDENCE 85
IMPORTANCE 80
RELEVANCE 90
NEGATIVE IMPACT
Eisai Co Ltd faces a delay in the EMA approval process for Alzheimer's drug Lecanemab, partnered with Biogen, due to procedural issues.
As a partner in the development of Lecanemab, Eisai is directly impacted by the EMA's delay. This could affect Eisai's strategic plans and financial forecasts for the drug.
CONFIDENCE 80
IMPORTANCE 75
RELEVANCE 80
NEGATIVE IMPACT
Eisai Co Ltd faces a delay in the EMA approval process for Alzheimer's drug Lecanemab, partnered with Biogen, due to procedural issues.
As a partner in the development of Lecanemab, Eisai is directly impacted by the EMA's delay. This could affect Eisai's strategic plans and financial forecasts for the drug.
CONFIDENCE 80
IMPORTANCE 75
RELEVANCE 80