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Biogen's Autoimmune Disease Candidate Gets FDA's Breakthrough Status
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Key Takeaways
BIIB received FDA Breakthrough Therapy designation for litifilimab to treat cutaneous lupus erythematosus.
Biogen cited phase II LILAC results showing litifilimab cut skin disease activity versus placebo in CLE.
A phase III CLE study of litifilimab is ongoing, with data expected in 2027, plus two lupus studies.
Biogen (BIIB - Free Report) announced that the FDA has granted the Breakthrough Therapy designation to its investigational, first-in-class, humanized IgG1 mAb targeting BDCA2, litifilimab (BIIB059), to treat patients with cutaneous lupus erythematosus (CLE).
Benefits of the FDA’s Breakthrough Therapy Designation Grant
The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when early clinical evidence suggests the drug may significantly improve over existing treatments on one or more important clinical measures. Drugs with this designation receive more intensive guidance and organizational support from senior FDA managers.
The FDA’s decision was supported by the full body of evidence for Biogen’s litifilimab, including results from the phase II LILAC study, which demonstrated that litifilimab significantly reduced skin disease activity in patients with CLE compared to placebo. Current standard-of-care CLE treatments, such as topical steroids, antimalarials and immunosuppressants, primarily manage symptoms but do not slow or modify disease progression.
In the past six months, BIIB stock has gained 36.7% compared with the industry’s 23% growth.
Image Source: Zacks Investment Research
CLE is a chronic autoimmune skin disease that can occur with or without systemic lupus, causing rashes, pain, itching, photosensitivity, and progressive skin damage that may result in permanent scarring, hair loss, and discoloration. Lupus affects mostly women, often beginning between the ages of 15 and 40, and disproportionately impacts several ethno-racial groups. There is currently no cure.
Presently, Biogen is evaluating the efficacy and safety of litifilimab in the phase III AMETHYST study for CLE, with a data readout expected in 2027. The company is simultaneously evaluating the candidate in two separate late-stage studies for the potential treatment of systemic lupus erythematosus (SLE).
BIIB’s Other Immunology Pipeline Programs
Biogen’s immunology pipeline comprises two other late-stage candidates, dapirolizumab pegol and felzartamab, which are being developed across various indications. Dapirolizumab pegol, an anti-CD40L antibody, is currently undergoing phase III development for active SLE.
On the other hand, felzartamab, an anti-CD38 antibody, is undergoing phase III evaluation for three indications — antibody-mediated rejection, immunoglobulin A nephropathy, and primary membranous nephropathy — all in separate studies. Additionally, Biogen is also evaluating felzartamab in an early-stage study for lupus nephritis.
Last year, Biogen inked a research deal with Dayra Therapeutics to strengthen its immunology pipeline by adding a new class of oral therapies that could deliver biologic-like benefits without injections. By tapping Dayra’s macrocyclic peptide platform, Biogen can pursue hard-to-target immune pathways while improving patient convenience and adherence. The deal supports Biogen’s strategy to build a differentiated, long-term immunology portfolio, while leading late-stage development and commercialization.
Over the past 60 days, estimates for Regeneron Pharmaceuticals’ 2026 EPS have increased from $41.80 to $43.97. Shares of REGN have surged 35.4% over the past six months.
Regeneron Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters, missing the mark on the remaining occasion, delivering an average surprise of 21.81%.
Over the past 60 days, 2026 EPS estimates for Alkermes have increased from $1.54 to $1.91. Shares of ALKS have gained 21.4% over the past six months.
Alkermes’ earnings beat estimates in three of the trailing four quarters, missing on the remaining occasion, with the average surprise being 4.58%.
Over the past 60 days, estimates for Krystal Biotech’s EPS for 2026 have risen to $8.49 from $8.34. KRYS stock has rallied 78.1% over the past six months.
Krystal Biotech’s earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 40.43%.
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Biogen's Autoimmune Disease Candidate Gets FDA's Breakthrough Status
Key Takeaways
Biogen (BIIB - Free Report) announced that the FDA has granted the Breakthrough Therapy designation to its investigational, first-in-class, humanized IgG1 mAb targeting BDCA2, litifilimab (BIIB059), to treat patients with cutaneous lupus erythematosus (CLE).
Benefits of the FDA’s Breakthrough Therapy Designation Grant
The FDA’s Breakthrough Therapy designation is a process that speeds up the development and review of drugs for serious or life-threatening conditions. This designation is granted when early clinical evidence suggests the drug may significantly improve over existing treatments on one or more important clinical measures. Drugs with this designation receive more intensive guidance and organizational support from senior FDA managers.
The FDA’s decision was supported by the full body of evidence for Biogen’s litifilimab, including results from the phase II LILAC study, which demonstrated that litifilimab significantly reduced skin disease activity in patients with CLE compared to placebo. Current standard-of-care CLE treatments, such as topical steroids, antimalarials and immunosuppressants, primarily manage symptoms but do not slow or modify disease progression.
In the past six months, BIIB stock has gained 36.7% compared with the industry’s 23% growth.
Image Source: Zacks Investment Research
CLE is a chronic autoimmune skin disease that can occur with or without systemic lupus, causing rashes, pain, itching, photosensitivity, and progressive skin damage that may result in permanent scarring, hair loss, and discoloration. Lupus affects mostly women, often beginning between the ages of 15 and 40, and disproportionately impacts several ethno-racial groups. There is currently no cure.
Presently, Biogen is evaluating the efficacy and safety of litifilimab in the phase III AMETHYST study for CLE, with a data readout expected in 2027. The company is simultaneously evaluating the candidate in two separate late-stage studies for the potential treatment of systemic lupus erythematosus (SLE).
BIIB’s Other Immunology Pipeline Programs
Biogen’s immunology pipeline comprises two other late-stage candidates, dapirolizumab pegol and felzartamab, which are being developed across various indications. Dapirolizumab pegol, an anti-CD40L antibody, is currently undergoing phase III development for active SLE.
On the other hand, felzartamab, an anti-CD38 antibody, is undergoing phase III evaluation for three indications — antibody-mediated rejection, immunoglobulin A nephropathy, and primary membranous nephropathy — all in separate studies. Additionally, Biogen is also evaluating felzartamab in an early-stage study for lupus nephritis.
Last year, Biogen inked a research deal with Dayra Therapeutics to strengthen its immunology pipeline by adding a new class of oral therapies that could deliver biologic-like benefits without injections. By tapping Dayra’s macrocyclic peptide platform, Biogen can pursue hard-to-target immune pathways while improving patient convenience and adherence. The deal supports Biogen’s strategy to build a differentiated, long-term immunology portfolio, while leading late-stage development and commercialization.
Biogen Inc. Price and Consensus
Biogen Inc. price-consensus-chart | Biogen Inc. Quote
BIIB’s Zacks Rank & Stocks to Consider
Biogen currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Regeneron Pharmaceuticals (REGN - Free Report) , Alkermes (ALKS - Free Report) and Krystal Biotech (KRYS - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Regeneron Pharmaceuticals’ 2026 EPS have increased from $41.80 to $43.97. Shares of REGN have surged 35.4% over the past six months.
Regeneron Pharmaceuticals’ earnings beat estimates in three of the trailing four quarters, missing the mark on the remaining occasion, delivering an average surprise of 21.81%.
Over the past 60 days, 2026 EPS estimates for Alkermes have increased from $1.54 to $1.91. Shares of ALKS have gained 21.4% over the past six months.
Alkermes’ earnings beat estimates in three of the trailing four quarters, missing on the remaining occasion, with the average surprise being 4.58%.
Over the past 60 days, estimates for Krystal Biotech’s EPS for 2026 have risen to $8.49 from $8.34. KRYS stock has rallied 78.1% over the past six months.
Krystal Biotech’s earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 40.43%.