Biogen Inc.: Leqembi SC initiation approved early but immediate impact likely modest

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Biogen Inc.: Leqembi SC initiation approved early but immediate impact likely modest

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Biogen Inc.

Leqembi SC initiation approved early but

immediate impact likely modest

Maintain Rating: NEUTRAL | PO: 217.00 USD | Price: 208.60 USD

Approval arrives early, utilization remains the debate 13 July 2026

This afternoon, FDA approved Biogen/ Eisai’s subcutaneous (SC) formulation of Leqembi Equity

for treatment initiation. The decision itself isn’t particularly surprising to us, especially

Jason Zemansky

after data presented yesterday at AAIC (London) showed comparable safety/ efficacy to Research Analyst

IV administration. Still, the decision came ~6 weeks ahead of the revised Aug 24 PDUFA BofAS jason.zemansky@bofa.com

(extended from May 24; see our delay takes)—likely contributing to the stock’s strength

Jacqueline Plesset

today (+4% vs. NBI -2%). We had suspected the additional review centered on safety, Research Analyst

particularly as the worrisome ARIA usually occurs early. That said, a review of the new BofAS jacqueline.plesset@bofa.com

label reveals no major new precautions, suggesting the companies were able to address

regulators’ concerns. Still, with approval unlikely to have an impact on uptake, we don’t

view today’s decision as thesis-changing. Maintain Neutral, $217 PO.

Stock Data

Convenience alone unlikely to inflect uptake Price 208.60 USD

While even our prescribers skeptical of Leqembi’s value acknowledge convenience has Price Objective 217.00 USD

constrained the class, few expect available SC initiation to inflect uptake. Availability of Date Established 8-Jul-2026

SC maintenance dosing since Aug 2025—arguably the phase where convenience should Investment Opinion B-2-9