Eisai and Biogen Launch LEQEMBI IQLIK, FDA Review Set for May 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1h ago
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Source: PRnewswire
- FDA Review Progress: Eisai and Biogen announced that the FDA has accepted the Supplemental Biologics License Application for LEQEMBI IQLIK, with a review date set for May 24, 2026, which, if approved, will be the first treatment for Alzheimer's disease to offer at-home injection options, significantly enhancing patient convenience.
- Innovative Administration Method: The 500 mg subcutaneous injection regimen of LEQEMBI IQLIK will replace the current bi-weekly intravenous dosing, allowing patients to choose home administration, which is expected to reduce healthcare resource consumption and improve patient adherence, thereby enhancing overall treatment outcomes.
- Clinical Data Support: Clinical trial data indicate that the once-weekly 500 mg subcutaneous injection of LEQEMBI IQLIK achieves equivalent drug exposure and clinical effects compared to bi-weekly intravenous administration, with a similar safety profile and less than 2% incidence of injection-related adverse reactions, laying a solid foundation for market promotion.
- Global Market Potential: LEQEMBI is currently approved in 53 countries and regions and under regulatory review in 7 countries, with the collaboration between Eisai and Biogen further driving its penetration into global markets to meet the growing demand among Alzheimer's disease patients.
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.
