Telix Pharmaceuticals Ltd (ASX: TLX) shares had another day to forget on Thursday.
The ASX 200 stock ended the day 19% lower at $14.95.
This means that the radiopharmaceuticals company's shares are now down a sizeable 53% from their 52-week high.
Is this a buying opportunity for investors? Let's see what Bell Potter is saying about the fallen star.
What's happening to this ASX 200 stock?
Bell Potter notes that Telix has received bad news this week from the US Food and Drugs Administration (FDA).
The regulator has denied approval of the Biological License Application for Zircaix, issuing a Complete Response Letter (CRL). It explains:
The CRL sighted deficiencies in Chemistry, Manufacturing and Controls. The Agency requires further comparability data on the large scale manufacturing processes for commercial use i.e. to establish comparability between the drug used in the approval studies and the commercial product. In addition, it sighted two form 483 notices related to deficiencies at 3rd party manufacturing and supply chain partners.
This is the second CRL for Telix in 2025, which appears to have spooked investors and sent many rushing to the exits.
Is it a buying opportunity?
Despite this disappointment, Bell Potter remains positive on the ASX 200 stock and believes that investors should be buying the dip.
In response to the news and the selloff, the broker has retained its buy rating but with a heavily reduced price target of $23.00 (from $30.00).
Based on its current share price of $14.95, this implies potential upside of 54% for investors over the next 12 months.
To put that into context, if Bell Potter is on the money with its recommendation, a $10,000 investment in this ASX 200 stock would be worth over $15,000 by this time next year.
Commenting on its buy recommendation for Telix shares, the broker said:
The previous forecast included modest revenues from Zircaix in FY26 ($31m) which is now stripped out and EBITDA is reduced by $13m. The company does not plan to curtail any R&D spend at this point as it remains well capitalised and we expect will continue to generate cash from operations. This is the second CRL for TLX this calendar year. The delay to revenues and knock on effect to the cost of capital (risk) and valuation are material, accordingly our TP is reduced from to $23.00.
All in all, this could make it worth considering this beaten down stock if you are looking for exposure to the healthcare sector.
