Biogen Secures FDA Nod for Subcutaneous Maintenance Dosing of Leqembi

Biogen BIIB announced that the FDA has approved a subcutaneous (SC) autoinjector version of Leqembi as a weekly maintenance dosing option for the treatment of early Alzheimer’s disease (AD). This version will be marketed under the brand name Leqembi Iqlik.

Post the FDA approval, patients have the option to transition to a weekly maintenance dosing regimen using Leqembi Iqlik after completing an 18-month course of biweekly infusions of the drug. Alternatively, patients can also opt to go with a monthly maintenance dosing regimen of intravenously (IV) administered Leqembi, which was approved earlier in January.

The new option provides relief to AD patients taking Leqembi, as IV administrations are time-consuming — nearly one hour for each infusion. According to Biogen, this SC version can be administered in about 15 seconds and can even be used by patients at home or in medical centers.

The latest FDA approval is supported by data from multiple clinical studies, which indicated that transitioning to a weekly maintenance dosing using Leqembi Iqlik sustained both clinical and biomarker benefits that were similar to continued IV dosing. Biogen plans to commercially launch this version on Oct. 6, 2025.

Leqembi was initially approved by the FDA in 2023 as a biweekly medication (for both initial and maintenance dosing) to treat AD patients with mild cognitive impairment (MCI) or mild dementia stage of disease (collectively referred to as ‘early AD’). The drug was approved for a similar indication in the European Union in April.

Biogen has developed Leqembi in collaboration with Japan-based Eisai, with the latter leading the clinical development and regulatory submissions. Though both companies co-commercialize and co-promote the drug, Eisai has the final decision-making authority.

BIIB’s Stock Performance

Shares of Biogen have underperformed the industry year to date, as seen in the chart below.

Biogen Boasts Potential Blockbuster of Leqembi

Though Leqembi’s launch was slow, it picked up in 2024, with the positive trend continuing in 2025. Eisai recorded nearly $160 million in global revenues from Leqembi sales in the second quarter of 2025, showing a strong improvement from $96 million in the previous quarter.

Biogen believes it has the potential to generate blockbuster sales, as there remains a massive unmet need for AD.

Marketed Drugs in the AD Space

Currently, there are two drugs approved by the FDA in the AD space — Leqembi and Kisunla, which were developed by Eli Lilly LLY and received the FDA’s approval last year.

Both Biogen/Eisai’s Leqembi and Lilly’s Kisunla are approved to treat early symptomatic AD, which includes mild cognitive impairment or the dementia stage of the disease. The Biogen/Eisai and Lilly drugs are based on similar mechanisms, reducing the accumulation of amyloid beta (Aβ) plaque in the brain. Aβ is a protein that is said to be the primary cause of the cognitive decline associated with AD.

Like Leqembi, Kisunla has also been experiencing a rapid uptake. During the second quarter, Lilly recorded Kisunla sales worth $48.6 million in the second quarter compared with $21.5 million in the previous quarter as the new drug saw a steady launch trajectory.

Biogen Inc. Price

 

Biogen Inc. price | Biogen Inc. Quote

BIIB’s Zacks Rank

Biogen currently carries a Zacks Rank #3 (Hold).

Key Picks Among Biotech Stocks

Some better-ranked stocks from the sector are ANI Pharmaceuticals ANIP and CorMedix CRMD, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $6.51 to $7.25. EPS estimates for 2026 have increased from $7.05 to $7.74 during the same period. Year to date, shares of ANIP have surged 69%.

ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 22.66%.

Estimates for CorMedix’s 2025 EPS have increased from $1.10 to $1.49 over the past 60 days, while the same for 2026 has increased from $1.46 to $2.16. CRMD shares have soared 83% year to date.

CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.

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