Shares in CSL experienced a downturn of 2.5 per cent following recent news regarding regulatory developments and competitor guidance. A Citi analyst, Laura Sutcliffe, has indicated that these events present a minor negative outlook for the Australian biopharmaceutical giant. CSL is a global biotechnology leader that researches, develops, manufactures, and markets a range of life-saving and life-extending biotherapies. The company’s focus is on serving patients with rare and serious diseases.
The European Medicines Agency (EMA) announced on January 30 that it would review Tavneos, a treatment for rare kidney disease, due to concerns about the integrity of the clinical study that supported its approval in 2022. CSL holds the marketing rights for Tavneos outside the United States. However, Citi estimates that Tavneos only contributes approximately 1 per cent to its fiscal year 2026 revenue forecast.
In separate news, Daiichi Sankyo has cut its guidance for intravenous (IV) iron products in the US for the second consecutive quarter. This revision reflects the increasing generic and price competition affecting Vifor’s Venofer and Injectafer, products in which CSL has invested.
Sutcliffe commented that the performance of CSL’s Behring segment, the growth in the immunoglobulin (Ig) business, and confidence in the company’s management remain the most significant factors influencing CSL’s share price. She added, “We think Vifor had reached close to benign status in investors’ minds recently and view these developments as incrementally negative.”
