Biogen Receives FDA Breakthrough Therapy Designation for Litifilimab
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 20h ago
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Source: Newsfilter
- FDA Breakthrough Therapy Designation: Biogen's litifilimab (BIIB059) has received FDA Breakthrough Therapy Designation for treating cutaneous lupus erythematosus (CLE), indicating the FDA's recognition of the drug's potential in addressing serious diseases and potentially expediting its market entry.
- Clinical Trial Data Support: Results from the Phase 2 LILAC study demonstrate that litifilimab significantly reduces skin disease activity in CLE patients compared to placebo, highlighting its potential to improve patient quality of life.
- Urgent Market Need: Current standard treatments for CLE include topical steroids and antimalarials, but there are no targeted therapies available, making litifilimab's development crucial to meet the urgent demand for effective treatments among patients.
- Future Research Plans: Biogen is advancing the AMETHYST Phase 3 study, with data readout expected in 2027, which, if successful, could provide a new therapeutic option for millions of CLE patients, further solidifying Biogen's leadership in the biopharmaceutical sector.
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: 174.120
Low
135.00
Averages
186.19
High
250.00
Current: 174.120
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.
