By Matt Bell
Telix Pharmaceuticals is the biggest riser on Friday after US regulators accepted the resubmitted application for its brain cancer imaging agent.
Shares in the group rose 5 per cent to $14.31, which would be its highest close since December 2025.
Wilson Asset Management Leaders deputy portfolio manager Anna Milne said that after a challenging 12 months for Telix, the acceptance was another positive milestone following the strong quarterly results earlier this week.
“While not overly material to the broader Telix investment thesis and valuation, it’s an encouraging indication that dialogue with the FDA (US Food and Drug Administration) is constructive,” she said.
“From here, we are watching for Pixclara’s September PDUFA (Prescription Drug User Fee Act) date, as well as any update on Zircaix, which was also issued a CRL by the FDA last year.”
Citi analyst Laura Sutcliffe said the FDA’s acceptance and assignment of a September 11 decision date confirmed a standard six-month re-review process, leaving the broker’s forecasts unchanged and reinforcing expectations the drug would be approved and launched shortly afterwards.
Citi models peak sales of about $US130 million, though said this could prove conservative if the drug’s label expands over time, providing upside beyond current assumptions.
Licensed by Copyright Agency. You must not copy this work without permission.
