Telix Pharmaceuticals Ltd (ASX: TLX) shares are ending the week on a positive note.
In morning trade on Friday, the ASX 200 healthcare stock is up 4.5% to a record high of $27.00.
Why is this ASX 200 healthcare stock racing higher?
Investors have been bidding the radiopharmaceuticals company's shares higher this morning following the release of an update on its Illuccix product.
Illuccix is a prescription radioactive diagnostic agent that is prepared by a healthcare provider and, then injected. It is used with a medical imaging procedure called Positron Emission Tomography (PET) of lesions identified as prostate-specific membrane antigen (PSMA) positive. It has been approved by the U.S. Food and Drug Administration (FDA), by the Australian Therapeutic Goods Administration (TGA), and by Health Canada.
Well, it is time to add another regulatory body to the approval list. That's because this morning the ASX 200 healthcare stock revealed that it has received a positive decision on the Marketing Authorization Application (MAA) for the prostate cancer PET1 imaging agent Illuccix, which was submitted in Europe via a decentralised procedure (DCP).
According to the release, this significant milestone follows the issuance of the Final Assessment Report from the German Competent Authority BfArM2 as Reference Member State (RMS).
Through the DCP, the RMS and all 18 European Economic Area (EEA) Concerned Member States (CMS) agree that Illuccix should receive marketing authorisation. The DCP regulatory process will now transition into an administrative national phase to implement authorisations to facilitate commercial launch in each country.
The company notes that PSMA-PET imaging represents a major advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT6 scan) as the standard of care after initial diagnosis and biochemical recurrence (BCR).
European guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease and evaluation of BCR/biochemical persistence (BCP).
'Delighted'
The ASX 200 healthcare stock's, chief executive officer of Precision Medicine, Kevin Richardson, commented:
We are delighted by this positive outcome, setting the stage for a European commercial launch of Illuccix. This clinically important prostate cancer imaging modality is currently recommended in international clinical practice guidelines including European Association of Urology (EAU) and European Society for Medical Oncology (ESMO).
If everything goes to plan, this could be a lucrative market for Telix. After all, the company generated US$517 million in sales over the past 12 months (up 55% year on year) outside the region. These sales were predominantly from Illuccix. Adding such a large market could support further strong growth in FY 2025.
