SYDNEY, June 27, 2026, 02:02 AEST
- CSL Limited (ASX:CSL) ended regular trade at A$114.87, off 2.36%. The move came ahead of a post-market EU setback tied to Tavneos, a CSL Vifor drug.
- The stock remains up 24.5% from its June 3 close. But Friday’s volume came in at just 2.31 million, a sharp drop from the 8.16 million shares traded on June 19.
- CSL Seqirus is set for operational separation on July 1. The company will report full-year results and its next impairment update on Aug. 18.
CSL Limited (ASX:CSL) heads into Monday facing more heat on Vifor after falling 2.36% to A$114.87 Friday, even as the S&P/ASX 200 (INDEXASX:XJO) edged up 0.18% to 8,764.20. That means CSL still hasn’t priced in the Tavneos update, which landed after ASX cash trading closed at 16:00 Sydney time. Next chance comes when trading starts at 09:59:45.
EU drug regulators have advised pulling the marketing authorisation for Tavneos, Reuters said at 11:10 UTC Friday. Tavneos is Amgen Inc’s (NASDAQ:AMGN) rare disease drug, managed in Europe by CSL Vifor. The EMA news landed after the ASX cash session closed.
CSL’s rebound hasn’t drawn much conviction from the market. The stock has rallied A$22.63, or 24.5%, from its June 3 close at A$92.24. With 478.91 million shares outstanding, according to Google Finance, that adds about A$10.8 billion back to the company’s market cap. But shares remain about 58% under the 52-week high of A$275.79.
The rally slowed ahead of the EU announcement. CSL jumped 7.62% on June 19, trading 8.16 million shares that day. On Friday, turnover dropped to 2.31 million shares, similar to Google Finance’s usual average of 2.15 million. CSL finished the week down 1.2% from the June 19 close of A$116.32.
The European Medicines Agency flagged issues with good clinical practice and data reliability in the study behind Tavneos’ EU approval, Reuters reported. The FDA had moved to pull U.S. approval too and found 76 reports of drug-induced liver injury tied to the drug, also per Reuters.
CSL and Vifor Fresenius Medical Care Renal Pharma said the European Commission’s decision is expected soon. If approved, Tavneos would lose its EU authorisation and no new patients in the EU or European Economic Area could start on the drug. Bill Mezzanotte, CSL’s head of research and development, said, “Patient care remains our highest priority.” Global Newsroom | CSL
CSL holders are facing another hit from the same division that was behind most of the May shake-up. CSL said back on May 11 it was looking at around $5 billion in extra non-cash, pre-tax impairments for FY26 and FY27. That covers CSL Vifor intangible assets and some under-used property, plant and equipment.
The May update lowered FY26 guidance to around $15.2 billion revenue and NPATA of $3.1 billion. Both figures are at constant currency and exclude restructuring and impairments. Management said the $300 million revenue drop was tied to U.S. immunoglobulin channel inventory. They also flagged a $200 million impact from China albumin market value and $150 million from other sources.
Interim CEO Gordon Naylor said at the time that CSL’s “growth initiatives are working,” but warned profits would need more time to come through. Now the share price is up against yet another regulatory problem with the Vifor portfolio, putting the recovery story to the test.
CSL Seqirus is set to complete its operational separation July 1, the company’s scheduled date. That’s also when Diego Sacristan is supposed to step in as chief commercial officer at CSL Behring and CSL Vifor.
CSL’s vaccines unit had already been under strain. Marc Jocum, senior product and investment strategist at Global X ETFs, told Reuters in April that a Pentagon policy change on flu shots “adds incremental pressure at the worst possible time.” According to Reuters, CSL Seqirus made roughly $2.17 billion in fiscal 2025—about 14% of the group’s total revenue. Reuters
CSL will report full-year results on Aug. 18. The company said the results will have the next update on the impairment work.
