Biogen to present dapirolizumab pegol SLE study results at ACR

CAMBRIDGE - Biogen Inc. (NASDAQ:BIIB), a prominent biotechnology company with a market capitalization of $21.44 billion and impressive gross margins of 76.3%, announced it will present data from studies of dapirolizumab pegol (DZP), an investigational Fc-free anti-CD40L drug candidate for systemic lupus erythematosus (SLE), at the upcoming American College of Rheumatology Convergence 2025 in Chicago. According to InvestingPro analysis, Biogen currently trades below its Fair Value, suggesting potential upside opportunity.

The presentations, scheduled for October 24-29, will showcase efficacy results across multiple endpoints including low disease activity/remission, flares, fatigue, joint pain and quality of life from the Phase 3 PHOENYCS GO trial. Preclinical data demonstrating minimal to no placental transfer of DZP will also be presented.

In the Phase 3 study, DZP met the primary endpoint of improvement of moderate-to-severe disease activity as assessed by BICLA after 48 weeks. However, as the first key secondary endpoint had a p-value of 0.1776, all subsequent endpoints are considered descriptive. With a healthy P/E ratio of 14 and strong financial health metrics (rated "GREAT" by InvestingPro), Biogen maintains robust financial positioning to support its drug development pipeline.

"The data we are presenting at ACR Convergence strengthen our understanding of the range of effects dapirolizumab pegol has in systemic lupus erythematosus," said Diana Gallagher, MD, Head of AD, MS and Immunology Development Units at Biogen.

DZP is one of only three biologics to report positive Phase 3 data in a global SLE study, according to the company. A second Phase 3 study, PHOENYCS FLY, is currently ongoing.

The drug candidate is being developed under a collaboration between Biogen and UCB. It works by inhibiting CD40L signaling, which has been shown to reduce B cell activation and autoantibody production, mitigate type 1 interferon secretion, and attenuate T cell and antigen-presenting cell activation.

The information in this article is based on a press release statement from Biogen. For comprehensive financial analysis and additional insights about Biogen, including 6 more exclusive ProTips and detailed valuation metrics, visit InvestingPro, where you can access the complete Pro Research Report covering what really matters about this biotechnology leader.

In other recent news, Biogen announced it anticipates approximately $2 million in research and development expenses for the third quarter of 2025, which is expected to reduce net income per share by about $0.01. RBC Capital has adjusted its price target for Biogen to $217 from $219 while maintaining an Outperform rating, projecting that the company may exceed consensus estimates for both revenue and earnings per share in its upcoming report. RBC forecasts revenue of $2,493 million and earnings per share of $4.43, higher than the consensus estimates. Additionally, Jefferies has initiated coverage of Biogen with a Buy rating and a $190 price target, noting low market expectations and potential for positive developments in 2026. In a product-related update, Biogen and Eisai have made the Leqembi Iqlik subcutaneous injection available in the U.S. for Alzheimer’s patients, following FDA approval in August 2025. This new dosing option comes after patients complete 18 months of intravenous treatment. Furthermore, Jesús Mantas, who serves on Biogen’s board, has been appointed to the board of the National Association of Corporate Directors.

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