The Telix Pharmaceuticals Ltd (ASX: TLX) share price is all over the place in early trade this morning after the company announced a significant update.
The biotechnology company's shares opened higher today, peaking at $8.15, before plunging to a low $7.70. At the time of writing, its shares are hovering around their previous closing price of $7.79.
Let's take a look at what might be impacting the Telix share price today.
What did Telix announce?
In today's announcement, Telix advised it has received the tick of approval from the US Food and Drug Administration (FDA) for its lead product, Illuccix.
The company has developed Illuccix for the diagnostic imaging of men with prostate cancer. It is the first commercially available product in the United States that provides access to what is known as gallium-68 PSMA-PET imaging.
Telix's prostate cancer diagnostic tool has been gaining momentum for investors in recent months.
The tool will be used on prostate cancer patients at risk of metastasis and those who have a biochemical recurrence.
Tulane Cancer Centre medical director Dr Oliver Sartor was full of praise for the imaging tool.
This product offers a level of flexibility and accessibility to healthcare professionals we really haven't seen before in this class of products, and may help us provide better patient experiences as a result.
Telix already has approval from the Therapeutic Good Administration for Illuccix in Australia. And the company is working on market authorisation in Europe and Canada.
Management comment
Commenting on the announcement, Telix CEO and managing director Dr Christian Behrenbruch said:
This heralds a new era of patient and physician access to gallium-based PSMA-PET imaging and marks an important new stage for Telix as we bring our first commercial product to market in the United States.
Improved imaging can provide physicians with the insights to determine the most appropriate treatment pathway and give patients in the US access to a specific and sensitive imaging tool for the detection of prostate cancer throughout the body.
Telix share price snap shot
The Telix share price has blasted ahead by more than 102% in the past 12 months. The company's shares have also shot up 10.5% in the past month.
The biopharmaceutical company has a market capitalisation of around $2.3 billion based on its current share price.
