Biogen begins phase 3 trial of felzartamab for kidney disease

CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB), a prominent biotechnology company with a market capitalization of $18.47 billion and strong financial health metrics according to InvestingPro, announced Monday it has initiated dosing in PROMINENT, a global Phase 3 clinical study evaluating felzartamab against tacrolimus in adults with primary membranous nephropathy (PMN).

The study will enroll approximately 180 adults with PMN, with results expected in 2029. PMN is a rare immune-mediated kidney disease that can lead to kidney failure, affecting an estimated 36,000 patients in the United States. The company maintains a robust gross profit margin of 75.65% and trades at a P/E ratio of 12.42, suggesting efficient operations despite significant R&D investments.

Felzartamab, an investigational anti-CD38 monoclonal antibody, targets CD38+ cells including plasma cells that produce autoantibodies involved in PMN. Up to 80% of PMN patients have autoantibodies against PLA2R generated by these cells.

"We are encouraged by the opportunity to advance a Phase 3 study for primary membranous nephropathy, a condition that carries a significant risk of kidney failure," said Travis Murdoch, Head of the Biogen West Coast Hub.

The 104-week PROMINENT trial will measure the percentage of participants achieving complete remission of proteinuria at week 104 as its primary endpoint. The study will include both newly diagnosed and relapsed patients, and will evaluate anti-PLA2R positive and negative patients.

Currently, no therapies are specifically approved for PMN, with standard treatments ranging from immunosuppressants to chemotherapy.

In previous Phase 2 studies, felzartamab showed reductions in antibody titers as early as one week after treatment, with most patients showing responses at six months. Most adverse events were mild to moderate, with infusion-related reactions being the most common.

This marks Biogen’s third Phase 3 trial of felzartamab launched this year, following studies in kidney transplant rejection and IgA nephropathy. The information in this article is based on a company press release. According to InvestingPro analysis, Biogen currently appears undervalued, with additional insights available in the comprehensive Pro Research Report, part of InvestingPro’s coverage of over 1,400 US equities. Investors anticipating the company’s next earnings report on July 23, 2025, can access detailed financial metrics and expert analysis through the platform.

In other recent news, Biogen Inc. reported positive interim Phase 1 results for salanersen, a treatment for spinal muscular atrophy (SMA), showing promising outcomes in children previously treated with gene therapy. The company noted that both 40 mg and 80 mg doses were well-tolerated, leading to significant reductions in neurofilament levels and improvements in motor milestones. Biogen is now engaging with global health authorities to design Phase 3 studies for salanersen. Additionally, Biogen has initiated a Phase 3 trial of omaveloxolone for Friedreich ataxia (FA) in children, addressing an unmet need in younger patients. This trial aims to evaluate the treatment’s efficacy over a 52-week period with a subsequent open-label extension. In analyst activity, UBS has maintained a neutral rating on Biogen, citing potential opportunities in Alzheimer’s disease treatment but also noting uncertainties in timelines. Meanwhile, H.C. Wainwright reiterated a buy rating, highlighting Biogen’s focus on nephrology and the potential of felzartamab in establishing a nephrology franchise. These developments reflect Biogen’s ongoing efforts in advancing treatments for rare diseases.

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