CSL Faces Dual Regulatory Headwinds: EMA Recommends Tavneos Withdrawal as EU Opens Sanofi Flu Vaccine Probe
Key Insights
The European Medicines Agency has recommended pulling marketing authorization for Tavneos, citing unreliable efficacy data and good clinical practice concerns in the pivotal study.
The European Commission has opened an antitrust investigation into Sanofi's flu vaccine campaign, alleging misleading promotion that criticized CSL Seqirus (search)'s Fluad in France and Germany.
CSL shares closed at A$114.87 on Friday, down 2.36%, with the Tavneos news landing after ASX trading closed, leaving the stock yet to price in the regulatory setback.
CSL Limited (ASX:CSL) enters the new trading week confronting two separate European regulatory actions that threaten distinct segments of its business, with shares yet to fully absorb the impact of an after-market announcement that the European Medicines Agency (EMA) has recommended withdrawing marketing authorization for Tavneos.
The stock closed at A$114.87 on Friday, down 2.36% for the session, as the S&P/ASX 200 edged up 0.18% to 8,764.20. The EMA's Tavneos recommendation, reported by Reuters at 11:10 UTC Friday, landed after ASX cash trading had already closed at 16:00 Sydney time, meaning the market has not yet priced in the development.
Tavneos: EMA Cites Data Reliability Concerns
The EMA's human medicines committee advised pulling EU marketing authorization for Tavneos, a rare disease drug developed by Amgen and managed in Europe by CSL Vifor (search). The regulator determined that the benefits of the drug are no longer proven to outweigh its risks, stating that data from the main study supporting Tavneos' EU approval cannot be relied upon for effectiveness.
Reuters reported that the EMA flagged issues with good clinical practice and data reliability in the pivotal study. The U.S. Food and Drug Administration had already moved to withdraw Tavneos' American approval, identifying 76 reports of drug-induced liver injury (search) tied to the drug.
CSL and Vifor Fresenius Medical Care Renal Pharma indicated that a European Commission decision is expected soon. If the withdrawal is approved, Tavneos would lose its EU authorization, and no new patients in the EU or European Economic Area could start treatment with the drug.
Bill Mezzanotte, CSL's head of research and development, said: "Patient care remains our highest priority," adding that CSL will coordinate with regulators and doctors to manage treatment changes.
Sanofi Antitrust Probe Adds Flu Vaccine Pressure
In a separate development also emerging after the ASX close, Reuters reported that the European Commission has opened an antitrust investigation into Sanofi over possible violations of EU competition law related to a flu vaccine campaign. The Commission has concerns that Sanofi promoted its Efluelda (search) vaccine with a misleading campaign while criticizing CSL Seqirus (search)'s Fluad in France and Germany.
CSL Seqirus (search) generated approximately $2.17 billion in fiscal 2025 revenue, representing about 14% of the group's total revenue, according to Reuters. The unit had already been under strain, with Marc Jocum, senior product and investment strategist at Global X ETFs, telling Reuters in April that a Pentagon policy change on flu shots "adds incremental pressure at the worst possible time."
Financial Context: May Guidance Reset
CSL had already reset expectations in May, when management disclosed plans for approximately $5 billion in additional non-cash, pre-tax impairments across FY26 and FY27, covering CSL Vifor (search) intangible assets and under-used property, plant and equipment.
The company lowered FY26 guidance to approximately $15.2 billion in revenue and NPATA of $3.1 billion, both at constant currency and excluding restructuring and impairments. The $300 million revenue reduction was attributed to U.S. immunoglobulin channel inventory, with a further $200 million impact from China albumin market value and $150 million from other sources including slower HEMGENIX growth and iron market pressure.
Interim CEO Gordon Naylor said at the time that CSL's "growth initiatives are working," but cautioned that "financial benefits will take longer" to materialize.
Market Reaction and Upcoming Milestones
CSL shares have rallied 24.5% from their June 3 close of A$92.24, adding approximately A$10.8 billion in market capitalization. However, the stock remains roughly 58% below its 52-week high of A$275.79. Friday's trading volume of 2.31 million shares was sharply lower than the 8.16 million shares traded on June 19, when the stock jumped 7.62%.
CSL Seqirus (search) is scheduled to complete its operational separation on July 1, the same date Diego Sacristan is expected to assume the role of chief commercial officer at CSL Behring and CSL Vifor (search). The company will report full-year results and provide its next impairment update on August 18.