Biogen (NasdaqGS:BIIB) Gets US FDA Fast Track For Alzheimer's Despite US$8M Settlement

Biogen (NasdaqGS:BIIB) recently received Fast Track designation from the FDA for its Alzheimer's therapy, BIIB080, signaling a significant advancement in its drug development ambitions. However, despite these promising developments, Biogen's stock experienced a 7% decline over the past month. This slide is likely influenced by the broader market downturn following the introduction of new tariffs by President Trump, which saw major indexes like the Nasdaq Composite drop by 5%. Furthermore, while the settlement of a legal dispute contributed positively to Biogen's financials, it was insufficient to offset market-driven pressures.

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Over the last year, Biogen's total shareholder return was a stark 36.37% decline, underperforming both the US market and the biotechs industry during the same period. Several key factors influenced this downturn. In April and February 2025, while receiving positive regulatory news for its Alzheimer's therapies BIIB080 and lecanemab, these developments were more forward-looking and may not have immediately influenced shareholder returns. The decline in revenue, as announced in February 2025, can be tied partly to decreasing multiple sclerosis product revenue, highlighting a significant challenge for the company. Additionally, Biogen's earnings growth in late 2024 was overshadowed by market pressures and increased competition.

Biogen's strategic actions, such as completing significant share repurchases totaling US$2.95 billion in February 2025, reflected efforts to return value to shareholders despite overall performance challenges. On the legal front, a settlement related to a loan dispute was resolved in April 2025, complementing financial attempts to stabilize further. These events collectively explain Biogen's challenging year in shareholder returns.

Explore historical data to track Biogen's performance over time in our past results report.

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