There was a time when CSL Ltd (ASX: CSL) could almost do no wrong in the eyes of investors.
But that now feels like a very long time ago.
At the time of writing, the CSL share price is down 1.77% to $112.85.
This comes after the biotech giant released another disappointing update tied to its Vifor business.
It is the latest blow in what has become an absolutely brutal period for one of the ASX's former market darlings.
CSL shares are now down around 34% since the start of 2026 and have fallen more than 50% over the past year.
So, what's the latest to go wrong?
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CSL's Vifor troubles deepen in Europe
According to the release, CSL said a European Medicines Agency committee has recommended that marketing authorisation for TAVNEOS be revoked in the European Union (EU).
TAVNEOS, also known as avacopan, is sold by CSL Vifor affiliates in the EU and European Economic Area (EEA) under a licence agreement.
The treatment is used for adults with severe, active ANCA-associated vasculitis, a rare disease that causes inflammation in small and medium blood vessels.
The recommendation follows a review into the handling of data in the pivotal Phase 3 ADVOCATE clinical trial, which supported the product's approval.
CSL said the European Commission will now review the committee's opinion and make a final decision in due course.
In the meantime, the company expects to stop new patient starts in EU and EEA markets, in line with regulatory guidance.
Management commentary
CSL said it was disappointed with the outcome, but will respect the regulatory process.
Bill Mezzanotte, CSL's head of research and development, noted that the company recognises this is a difficult moment for the community.
He said:
Patient care remains our highest priority, and we are working closely with regulatory authorities, healthcare professionals and patient organisations.
CSL advised that sales revenue from TAVNEOS is expected to be approximately US$45 million in FY26.
The company will provide more details on the intellectual property impairment linked to TAVNEOS when it reports its FY26 full-year results on 18 August.
CSL also pointed out that today's announcement doesn't change the estimated impairment it provided to investors in May.
Why this still hurts
Despite the setback, keep in mind that TAVNEOS is tiny next to CSL's broader global operations.
However, Vifor has already been a major frustration for investors after CSL flagged large write-downs earlier this year.
So, another issue from the same part of the business was never going to land well.
CSL is still a global biotech heavyweight, with major plasma, vaccine, and iron deficiency businesses. Its market capitalisation also remains above $54.5 billion, so this isn't a business suddenly running out of options.
Nonetheless, investor trust has already been severely damaged.
