Long-suffering CSL Ltd (ASX: CSL) shareholders received another blow this week when the company revealed its Tavneos product could be blocked from sale in the European Union.
It's the latest in a string of bad news for the company over the past year or so, which has resulted in the share price dipping about 50%.
The question is, are the shares good buys at their current depressed levels, or are they fully priced?
The analyst team at Macquarie has an opinion on that, which we'll get to shortly.
First, let's look at what was announced this week.
Image source: Getty Images
Another setback for the company
CSL said in a statement to the ASX:
On 26 June 2026, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued an opinion recommending the revocation of the EU marketing authorisation for Tavneos. This opinion follows CHMP's review under Article 20 of the handling of data in the pivotal Phase 3 Advocate clinical trial supporting the product's approval.
CSL points out that the trial was done by a separate company, and it sells the product under licence.
It said the European Commission would review the CHMP opinion and issue a final decision "in due course".
CSL's Head of Research & Development, Dr Bill Mezzanotte, said:
While we are disappointed in the outcome of the Article 20 procedure, we will respect the regulatory process and are committed to implementing it in full. We recognise this is a difficult moment for the community, as Tavneos has played an important role for patients living with ANCA-associated vasculitis, a life-threatening disease with limited treatment options. VFMCRP (Vifor) and CSL remain focused on bringing innovative treatment options to patients living with rare diseases. Patient care remains our highest priority, and we are working closely with regulatory authorities, healthcare professionals and patient organisations to ensure a compliant and appropriate treatment transition, along with ongoing support for patients.
The company said sales revenue for Tavneos for FY26 was expected to be about $145 million.
CSL added:
Further detail, including impairment of TAVNEOS intellectual property, will be provided as part of CSL's 2026 Full Year results in August 2026. This announcement does not change the estimated impairment provided to investors on 11 May 2026.
CSL shares look fully valued
The Macquarie team said in their note to clients that a ruling from the European Commission was likely within 60 days and a decision striking out the treatment was "highly probable".
Macquarie has adjusted its FY27 forecasts for CSL to account for a 65% reduction in Tavneos revenue, "with no new patients treated in Europe effective immediately''.
They said:
We reiterate our Neutral rating amid significant uncertainty in near term earnings across the core business segments (IG, albumin) and ongoing competitive risks in the medium term.
Macquarie has a price target of $114 on CSL shares compared with $115.39 on Tuesday morning.
CSL is valued at $55.26 billion.
