The Telix Pharmaceuticals Ltd (ASX: TLX) share price is charging higher, up 4.8% in morning trade to $6.96 per share.
Below, we take a look at the latest regulatory approval that looks to be spurring investor interest in the ASX biotech share.
What regulatory approval was announced?
The Telix share price is gaining after the company reported that it has received approval for its prostate imaging product, Illuccix, from the Australian Therapeutic Goods Administration (TGA).
Illuccix is a “positron emission tomography agent” used to diagnose men with prostate cancer.
According to the release, Illuccix, after radiolabeling with gallium-68, is the first commercially approved PSMA-PET imaging agent available in Australia.
With the TGA approval, the company aims to provide state-of-the-art PSMA PET imaging for men across the country, including in regional areas.
Telix noted that prostate cancer was the second most common cause of cancer death for men in Australia in 2020, claiming some 3,500 lives. 17,000 new cases were diagnosed in Australia in 2020 alone.
What did management say?
Commenting on the TGA approval, Telix President David Cade said:
The approval of Illuccix means Australian patients with prostate cancer will have broad access to a TGA-approved PSMA-PET imaging agent. This new mode of imaging has been recognised in leading clinical practice guidelines as superior to conventional imaging with CT1 or MRI2, for the staging of prostate cancer.
Illuccix attaches to prostate cancer cells expressing PSMA and can be picked up by a PET scanner, giving physicians the ability to visualise tumour cells, including very small metastases, wherever they are in the body.
The Telix share price could also be getting a boost today from the wider implications of the TGA approval for other international markets.
According to Telix CEO Christian Behrenbruch, “This approval is an important milestone for Telix, demonstrating the approvability of Illuccix and establishing a blueprint for a series of near-term regulatory submissions and reviews in other important markets across the Asia Pacific.”
Telix share price snapshot
The Telix share price has been a star performer in 2021, up 83%. By comparison the All Ordinaries Index (ASX: XAO) is up 12% year-to-date.
Over the past month, Telix shares are up 20%.