Eisai submits sBLA for monthly maintenance dose of Alzheimer's drug Leqembi
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 01 2024
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Source: SeekingAlpha
- Eisai's Submission to FDA: Eisai has submitted an sBLA to the U.S. FDA for a monthly maintenance dose of Alzheimer's therapy Leqembi, aiming to transition patients from an intravenous infusion every two weeks to a monthly maintenance phase.
- Fast Track Designation: Eisai planned a rolling BLA for a subcutaneous version of Leqembi but was asked by the FDA to seek a separate Fast Track designation specific to the SC formulation, delaying the process.
- Future Steps: Eisai requested Fast Track designation for the SC formulation in March and will start a rolling submission upon approval, expected within 60 days from the submission date.
- Biogen Involvement: The therapy is marketed with Biogen, and recent events include Biogen Inc.'s participation in conferences and EU's delay in deciding on the Alzheimer's drug co-developed by Eisai and Biogen.
- Personnel Changes: Biogen's chief medical officer has left the company to join Alto Neuroscience board, indicating shifts in leadership within the organizations involved in the Alzheimer's therapy development.
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.
