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CAMBRIDGE, Mass. - Biogen Inc. (NASDAQ:BIIB) announced that its investigational drug, felzartamab, has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for treating a specific type of kidney transplant rejection. The FDA awards BTD to expedite the development and review of drugs that treat serious conditions and show promise over existing therapies.
Felzartamab is an anti-CD38 monoclonal antibody currently being studied for its potential to treat late antibody-mediated rejection (AMR) in kidney transplant patients without T-cell mediated rejection. AMR is a significant cause of kidney transplant failure, and effective treatment options are currently limited.
The BTD was supported by data from Biogen's clinical development program, including studies published in the New England Journal of Medicine and presented at the 61st European Renal Association Congress in Stockholm in May 2024. The designation will allow Biogen to engage with the FDA more effectively and take advantage of Fast Track designation features to accelerate felzartamab's development.
Travis Murdoch, Head of HI-Bio at Biogen, stated, "Antibody-mediated rejection is a major reason why kidney transplants fail, and currently patients suffering from AMR have tremendous unmet medical need. We are focused on tackling this important challenge, and the breakthrough therapy designation will enable us to work efficiently with the FDA to accelerate development of felzartamab in AMR."
Previously, felzartamab received BTD and Orphan Drug Designation (ODD) for primary membranous nephropathy (PMN) treatment and ODD for AMR treatment in kidney transplant recipients. Phase 2 studies in AMR, PMN, and IgA nephropathy (IgAN) have been completed, with Phase 3 trials planned to commence in 2025.
Felzartamab, initially developed for multiple myeloma, targets CD38, a protein on mature plasma cells. Its ability to selectively deplete these cells opens the possibility for treating a range of diseases caused by pathogenic antibodies. Biogen, a pioneer in biotechnology since 1978, acquired Human Immunology Biosciences (HI-Bio) in July 2024, gaining exclusive rights to develop and commercialize felzartamab outside of China.
As felzartamab is still under investigation, its safety and efficacy have not been established, and it has not yet received approval from any regulatory authority. This announcement is based on a press release statement from Biogen Inc.
In other recent news, Biogen Inc. reported significant advancements in its DEVOTE study, indicating potential clinical benefits of a higher dose regimen of nusinersen for individuals with spinal muscular atrophy (SMA). The study results, to be presented at the World Muscle Society 2024 Congress, suggest a faster reduction in neurodegeneration markers with the increased dose. Biogen plans to submit regulatory applications globally for approval of the higher dose regimen.
Additionally, Biogen reported a total revenue of $2.5 billion in its second-quarter results. Analyst firms including BMO Capital, Baird, TD Cowen, RBC Capital Markets, and Mizuho Securities have maintained an Outperform rating for the company.
In collaboration with UCB, Biogen reported successful results from a Phase III trial of Dapirolizumab pegol (DZP) for treating Systemic Lupus Erythematosus, with plans for a second trial in 2024. Furthermore, Biogen and Samsung (KS:005930) Bioepis achieved a significant regulatory milestone, with their biosimilar, OPUVIZ™, endorsed for marketing authorization by the European Medicines Agency's Committee for Medicinal Products for Human Use.
Lastly, Biogen expanded its Board of Directors with the appointment of Lloyd B. Minor, M.D., and Sir Menelas (Mene) Pangalos, Ph.D. These developments highlight Biogen's commitment to enhancing treatment options for diseases with unmet medical needs and expanding its product offerings in the biotechnology sector.
InvestingPro Insights
Biogen's recent breakthrough in kidney transplant rejection treatment aligns with its position as a prominent player in the biotechnology industry, as highlighted by InvestingPro Tips. The company's focus on innovative therapies like felzartamab demonstrates its commitment to addressing unmet medical needs, which could potentially bolster its market position.
Despite the positive news, InvestingPro data shows that Biogen's stock is currently trading near its 52-week low, with a market capitalization of $26.61 billion. This presents an interesting contrast to the company's ongoing research and development efforts. The stock's recent performance, with a 1-year price total return of -31.0%, suggests that investors may not have fully priced in the potential of Biogen's pipeline, including felzartamab.
An InvestingPro Tip indicates that Biogen's stock generally trades with low price volatility, which could be attractive for investors looking for stability in the often-volatile biotech sector. Additionally, the company's profitability over the last twelve months, as noted by another InvestingPro Tip, underscores its financial health despite the challenging stock performance.
For investors interested in a deeper analysis, InvestingPro offers 8 additional tips for Biogen, providing a more comprehensive view of the company's financial health and market position.
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