Milestone Leqembi approval is “a mixed bag,” analysts say, given drug label's risk warnings and infusion-center bottlenecks.
A milestone drug approval failed to boost Biogen Inc. BIIB shares early Friday, as analysts parsed the U.S. Food and Drug Administration’s action Thursday on Alzheimer’s treatment Leqembi.
Biogen has indicated that Leqembi won’t be profitable until late next year or 2025, noted the Raymond James analysts, who have a market-perform rating on Biogen’s stock. A subcutaneous version of Leqembi, which Eisai is developing now, “will be critical to unlock the Alzheimer’s market, especially given the biweekly IV infusion requirements and current infusion capacity constraints,” the analysts wrote.
The FDA’s decisions on the drug’s labeling drew scrutiny from analysts after the full approval. The label will have a boxed warning on the risks of amyloid-related imaging abnormalities, which often appear as temporary swelling in the brain but in rare cases can be severe and life-threatening, the FDA said. The full approval of Leqembi “is ultimately somewhat of a mixed bag,” Stifel analysts wrote in a report Thursday. The analysts have a buy rating on Biogen shares.
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