ASX:TLXBiotechs
Telix Pharmaceuticals (ASX:TLX) Is Up 7.1% After Resubmitting TLX101-Px NDA With FDA Fast Track Designation - Has The Bull Case Changed?
In March 2026, Telix Pharmaceuticals resubmitted its New Drug Application to the FDA for TLX101-Px (Pixclara, 18F-FET), an investigational PET imaging agent for distinguishing recurrent or progressive glioma from treatment effects in adult and pediatric patients, incorporating additional data and analysis requested after a prior Complete Response Letter.
The filing is significant because TLX101-Px holds both Orphan Drug and Fast Track designations and could become the first FDA-approved...