Biogen Shares Rise on Breakthrough Therapy Designation

Shares in Biogen (NASDAQ:BIIB) were trading marginally higher following the announcement that its investigational antibody felzartamab has received breakthrough therapy designation from US regulators for the treatment of late antibody-mediated rejection in kidney transplant patients.

In a statement on Tuesday, Biogen, based in Massachusetts, confirmed that the designation from the US Food and Drug Administration (FDA) is awarded to drug candidates targeting serious or life-threatening conditions, which have shown preliminary evidence of providing significant improvement over existing therapies.

Travis Murdoch, Head of Biogen's Human Immunology (HI-Bio) unit, stated, "Antibody-mediated rejection (AMR) 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."

AMR is a condition where the immune system produces antibodies that damage transplanted organs. Biogen announced plans to initiate late-stage trials for felzartamab in AMR and two other forms of kidney diseases by 2025. The treatment remains in the investigational phase, is not yet approved by any regulatory authority, and its safety and effectiveness are not yet established.

This news follows Biogen's agreement to acquire HI-Bio for up to $1.8 billion as part of a strategy to enhance its portfolio of rare disease medicines, including an upfront cost of $1.15 billion and additional payments of up to $650 million based on development milestones.

HI-Bio's felzartamab has previously completed mid-stage studies for primary membranous nephropathy and is also being tested in patients with IgA nephropathy, another form of chronic kidney disease.

(Reuters contributed reporting.)