MELBOURNE, June 30, 2026, 02:04 AEST
- CSL closed at A$115.39, gaining 0.45%. Volume came in at 1.46 million shares. The S&P/ASX 200 finished Monday up 0.68% at 8,823.40.
- CSL expects FY26 sales revenue from TAVNEOS at around $145 million and said this update leaves its impairment estimate, shared with investors on May 11, unchanged.
- TAVNEOS sales make up about 0.95% of CSL’s $15.2 billion FY26 revenue forecast. That’s less than the $300 million U.S. immunoglobulin and $200 million China albumin revenue impacts outlined in May.
- The ASX hadn’t reopened for normal trading at the dateline. ASX says cash market trading hours are from 09:59:45 to 16:00 Sydney time.
CSL Limited ASX:CSL inched up Monday, putting a price tag on its new European drug setback. The gain left CSL shares at A$115.39, up 0.45%. The S&P/ASX 200 did better, ending 0.68% higher at 8,823.40.
CSL picked up 22.49% in the last four weeks, but shares are still off 51.82% in the past year. The rally was no broad sign of support. Data is from June 29, Trading Economics.
Traders had a single figure to watch: FY26 TAVNEOS sales are seen at roughly $145 million. That’s under 1% of CSL’s forecast revenue of $15.2 billion for May.
| Item | Latest company figure | Share of FY26 revenue outlook |
|---|---|---|
| TAVNEOS FY26 sales | ~$145 mln | 0.95% |
| Drop to U.S. immunoglobulin revenue | ~$300 mln | 1.97% |
| Hit to China albumin revenue | ~$200 mln | 1.32% |
| Other revenue impact | ~$150 mln | 0.99% |
| FY26 revenue guide | ~$15.2 bln | 100% |
CSL’s June 29 TAVNEOS update and its May 11 financials are used in this comparison. Percentages are based on the $15.2 billion FY26 revenue target.
This is why Monday’s move is in focus. The TAVNEOS setback adds a new regulatory headache, but revenue at stake here is less than what CSL flagged back in May—U.S. immunoglobulin inventory problems and weaker albumin prices out of China. CSL also said the TAVNEOS announcement didn’t affect the impairment number it shared with investors on May 11.
CSL said the European Medicines Agency’s human medicines committee has recommended taking away EU marketing approval for TAVNEOS. The decision follows an Article 20 review into data handling from the Phase 3 ADVOCATE trial. CSL said it plans to halt new patient starts in EU and EEA markets while the European Commission looks at the committee’s opinion.
The EMA said benefits for the drug no longer outweigh the risks. In a statement, the agency said data from the ADVOCATE study isn’t enough to prove effectiveness anymore and told doctors not to start new patients, switching those already on the treatment to other options. The regulator pointed to higher risk of drug-related liver injury and vanishing bile duct syndrome.
Dr Bill Mezzanotte, head of R&D at CSL, said the company was “disappointed” but would respect the regulator’s process. “Patient care remains our highest priority,” he said.
CSL said TAVNEOS was first developed by ChemoCentryx, a company Amgen (NASDAQ:AMGN) picked up in 2022. The ADVOCATE study happened before CSL took over Vifor Pharma. CSL, its affiliates, and partners market the drug outside the U.S. and in certain countries, based on a collaboration and licence agreement from 2016.
The Vifor link stands out as the bigger issue for investors. Interim CEO Gordon Naylor in May lowered CSL’s FY26 targets to roughly $15.2 billion in revenue and $3.1 billion in NPATA, excluding any restructuring charges and impairments, all on a constant currency basis. CSL also warned of another $5 billion in non-cash, pre-tax impairments through FY26 and FY27. That includes impairments tied to CSL Vifor intangible assets.
Naylor said in May that CSL’s “growth initiatives are working,” though it would take more time for the results to feed through financially. The company will post full-year numbers and announce its final dividend on Aug. 18. CSL said there will be more on TAVNEOS, including details about the intellectual property impairment, with that announcement.
