The Telix Pharmaceuticals Ltd (ASX: TLX) share price is slipping today, down 2.5% in afternoon trading.
This comes despite the company reporting it had received priority review status from Australia’s Therapeutic Goods Administration (TGA) for its prostate cancer imaging product, TLX591-CDx.
The priority review provides Telix with a fast-tracked timeframe of 150 working days for its product dossier review and approval.
It’s possible this news was already factored into the share price. Telix shares soared 121% higher in the month of November, and the share price is up 152% year-to-date. By comparison, the S&P/ASX 200 Index (ASX: XJO) is flat since 2 January.
What does Telix Pharmaceuticals do?
Telix Pharmaceuticals is a biopharmaceutical company focused on developing diagnostic and therapeutic products via molecularly targeted radiation (MTR). Based in Melbourne, Telix has international operations in Belgium, Japan and the United States.
The company is currently developing a range of clinical-stage oncology products to address unmet medical needs involving prostate, kidney and brain cancers.
What does the priority review status mean for Telix shares?
Addressing the priority review status, Telix CEO Chris Behrenbruch said:
As an Australian headquartered company, we are especially delighted that the TGA has granted Priority Review for TLX591-CDx, bringing us one step closer to providing a commercially available prostate imaging agent to patients in our own backyard.
This is an important development for urologic oncology in Australia as a properly validated and commercially available product will ensure far greater patient access and confidence in the technology, currently only available on a limited basis under “special access” use from a relatively small number of academic nuclear medicine departments around the country.
The company reported that its Medical Services Advisory Committee (MSAC) application is already in progress. In a forward-looking statement, it revealed that it expects that MSAC approval and commercial availability of TLX591-CDx around May or June of 2021, provided it receives the TGA approval.
With prostate cancer killing 3,000 Aussie men each year (the second most common cause of cancer death), there are good reasons to hope Telix’s imaging product is successful beyond any share price gains.
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Motley Fool contributor Bernd Struben has no position in any of the stocks mentioned. The Motley Fool Australia has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Bruce Jackson.