Eisai Finalizes Rolling Submission of sBLA for Leqembi Iqlik to the FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 25 2025
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Eisai and Biogen Collaboration: Eisai Co. has completed the rolling submission of the Supplemental Biologics License Application (sBLA) for Leqembi Iqlik to the U.S. FDA, in partnership with Biogen.
FDA Fast Track Status: The FDA granted Fast Track Status to Leqembi, which is indicated for treating Alzheimer's disease in patients with Mild Cognitive Impairment or mild dementia.
Next Steps with FDA: Upon acceptance of the sBLA, the FDA will establish a Prescription Drug User Fee Act (PDUFA) action date for the application.
Leqembi's Indication: Leqembi is specifically aimed at patients in the early stages of Alzheimer's disease, focusing on those with Mild Cognitive Impairment or mild dementia.
Analyst Views on BIIB
Wall Street analysts forecast BIIB stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for BIIB is 186.19 USD with a low forecast of 135.00 USD and a high forecast of 250.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
25 Analyst Rating
11 Buy
13 Hold
1 Sell
Moderate Buy
Current: 173.800
Low
135.00
Averages
186.19
High
250.00
Current: 173.800
Low
135.00
Averages
186.19
High
250.00
About BIIB
Biogen Inc. is a global biopharmaceutical company. The Company is focused on discovering, developing, and delivering advanced therapies for people living with serious and complex diseases worldwide. It operates a portfolio of medicines to treat multiple sclerosis (MS), spinal muscular atrophy (SMA), Alzheimer's disease, and amyotrophic lateral sclerosis (ALS). It is focused on advancing its pipeline in neurology, specialized immunology, and rare diseases. Its marketed products include TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for the treatment of MS; SPINRAZA for the treatment of SMA; SKYCLARYS for the treatment of Friedreich's Ataxia; QALSODY for the treatment of ALS, and FUMADERM for the treatment of severe plaque psoriasis. It also collaborations with Eisai on the commercialization of LEQEMBI for the treatment of Alzheimer's disease and Sage on the commercialization of ZURZUVAE for the treatment of Postpartum Depression (PPD).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
