Biogen Highlights Lupus Pipeline at Symposium

Litifilimab and dapirolizumab programs in focus as company sees major unmet need in lupus treatment

Published on Feb. 14, 2026

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Biogen outlined its immunology and neurology development priorities during a virtual symposium hosted by Piper Sandler, with Dr. Diana Gallagher, head of clinical development, discussing the company's late-stage lupus programs and earlier-stage pipeline efforts. Gallagher emphasized the significant unmet need in lupus treatment, noting that only 20-30% of U.S. patients receive biologic therapy and many still do not reach treatment targets. She discussed Biogen's BDCA2 program (litifilimab) and CD40 program (dapirolizumab), highlighting their potential to address key manifestations of the disease like skin and joint involvement.

Why it matters

Lupus is a complex autoimmune disease that can be seriously undertreated, with many patients still not achieving desired outcomes like reduced disease activity and lower steroid use. Biogen's pipeline efforts in this area could help address this significant unmet medical need, providing new treatment options for lupus patients.

The details

Gallagher said Biogen's prioritization of lupus reflects the 'major unmet need' and the company's longstanding work in the space. The BDCA2 program (litifilimab) has been in development for over a decade, while the CD40 program (dapirolizumab) stems from a collaboration with UCB that has lasted around two decades. Litifilimab aims to interrupt inflammatory cascades by targeting the BDCA2 receptor on plasmacytoid dendritic cells, major producers of interferon. Dapirolizumab, which had successful Phase 3 results, incorporates protocol-defined steroid tapering to support patient wellness and enable statistical evaluation. Both programs are in late-stage trials using different primary endpoints (SRI-4 for litifilimab, BICLA for dapirolizumab) based on earlier proof-of-concept studies.

  • Biogen has studied CD40 biology through a collaboration with UCB for roughly two decades.
  • The BDCA2 program (litifilimab) has been in development for more than a decade.

The players

Biogen

A multinational biotechnology company focused on discovering, developing and delivering therapies for neurological and neurodegenerative diseases, with a longstanding emphasis on neuroscience.

Dr. Diana Gallagher

Head of clinical development for MS, immunology, and Alzheimer's disease at Biogen.

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What they’re saying

“Systemic lupus erythematosus (SLE) remains 'seriously undertreated,' citing that only about 20% to 30% of U.S. patients receive biologic therapy.”

— Dr. Diana Gallagher, Head of clinical development for MS, immunology, and Alzheimer's disease (themarketsdaily.com)

“Patients often express the idea that 'my lupus is not your lupus,' and argued that a broader set of options is needed because organ involvement and disease activity can change over time in a relapsing-remitting pattern.”

— Dr. Diana Gallagher, Head of clinical development for MS, immunology, and Alzheimer's disease (themarketsdaily.com)

What’s next

Biogen is considering how to examine questions around pregnancy and postpartum use of dapirolizumab, and is in dialogue with agencies about an appropriate path forward.

The takeaway

Biogen's pipeline efforts in lupus, including the litifilimab and dapirolizumab programs, have the potential to address the significant unmet need in this complex autoimmune disease by providing new treatment options that can help patients achieve better disease control and reduce long-term complications.