S&P/ASX 200 Index (ASX: XJO) healthcare stock Telix Pharmaceuticals Ltd (ASX: TLX) is marching higher today.
Shares in the diagnostic and therapeutic product developer closed yesterday trading for $27.80. In morning trade on Friday, shares are changing hands for $28.22 apiece, up 1.5%.
This sees the Telix share price up 112.6% since this time last year.
Investors who bought the ASX 200 healthcare stock five years ago, near the trough of the pandemic market sell-off, will now be sitting on gains of 3,143.7%.
Yep. That's no typo.
That's enough to have turned a $5,000 investment on 21 March 2020 into $162,185 today.
And Telix just announced that it has received another approval from the United States Food and Drug Administration (FDA).
Here's what's happening.
ASX 200 healthcare stock gets FDA greenlight
This morning, Telix reported that the FDA has approved its New Drug Application (NDA) for Gozellix, the ASX 200 healthcare stock's next generation PSMA-PET imaging agent for prostate cancer.
According to the release, Gozellix, after radiolabelling with gallium-68 (68-Ga), is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
Telix noted that Gozellix provides a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products.
This means that Gozellix can be delivered much further from its point of production and can, therefore, reach PET cameras that are currently not served by any PSMA imaging providers.
The ASX 200 healthcare stock said this would bring the accuracy and clinical utility of gallium-based imaging to more patients across the US. And with the formulation allowing for more scalable production, Gozellix has the potential to improve the efficiency, scheduling flexibility, and throughput of scanning clinics.
What did management say?
Commenting on the latest FDA approval for the ASX 200 healthcare stock, Telix Precision Medicine CEO Kevin Richardson said, "Securing FDA approval for Gozellix is a major win for prostate cancer patients, who gain enhanced access to state-of-the art 68-Ga PSMA-PET imaging."
Richardson added:
Telix continues to invest in innovation across our portfolio, and Gozellix is a testament to this continuous improvement approach. With the launch of Gozellix, our team is excited to be bringing the new generation of prostate cancer scanning to more American men, delivered with the reliability, service and flexibility that customers have come to expect from Telix.
Telix noted that to date, only a relatively small fraction of the 3.4 million men living with prostate cancer in the US have undergone this type of precision medicine scan.
