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Biogen Inc. (BIIB)'s Alzheimer's Drug Leqembi Wins EU Nod, Now Approved in 48 Countries

By Laiba Immad | September 02, 2025, 3:30 AM

We recently compiled a list of the 10 High Growth Pharma Stocks That Are Profitable in 2025. Biogen Inc. is one of them.

Biogen Inc. (NASDAQ:BIIB), founded in 1978 and headquartered in Cambridge, Massachusetts, continues to strengthen its leadership in neurological disorders, with a particular focus on Alzheimer’s disease. It stands tenth on our list among the high growth stocks. In April 2025, the European Commission approved lecanemab (Leqembi), developed with Eisai, marking Austria and Germany as its first EU markets. The therapy is now approved in 48 countries, with a U.S. FDA decision on a subcutaneous autoinjector formulation expected by August 31, 2025. Large Phase 3 trials, including AHEAD 3-45 for individuals at risk and Tau NexGen for inherited Alzheimer’s, highlight the company’s push into preclinical and familial forms of the disease.

To support this growing pipeline, Biogen Inc. (NASDAQ:BIIB) is investing $2 billion to expand its Research Triangle Park (RTP) operations in North Carolina. The new facility, set to be operational by late 2025, will feature advanced automation, expanded antisense oligonucleotide capabilities, and multi-platform fill-finish operations. With more than $10 billion invested in RTP since 1995, the business has cemented itself as a cornerstone of the state’s biopharma industry while ensuring a resilient supply for future launches.

Biogen Inc. (BIIB)’s Alzheimer’s Drug Leqembi Wins EU Nod, Now Approved in 48 Countries

Beyond Alzheimer’s, Biogen Inc. (NASDAQ:BIIB) is advancing therapies across multiple high-need areas. Zorevunersen, an antisense drug for Dravet syndrome, is expected to deliver pivotal Phase 3 results by 2027. Salanersen, a potential breakthrough for spinal muscular atrophy, is moving toward Phase 3 trials following positive early data. Felzartamab, an anti-CD38 therapy, is in late-stage studies for rare kidney diseases, while dapirolizumab pegol has shown encouraging results in lupus by improving fatigue and disease activity.

While we acknowledge the potential of BIIB as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock.

READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now.

Disclosure. None.

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