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Telix (ASX:TLX) share price charges higher on FDA update

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The market may be dropping lower today but that hasn’t stopped the Telix Pharmaceuticals Ltd (ASX: TLX) share price from charging higher.

In morning trade the biopharmaceutical company’s shares are up 3.5% to $1.82.

Why is the Telix share price charging higher?

Investors have been buying Telix’s shares on Thursday after it provided an update on its TLX591-CDx product.

TLX591-CDx is a proprietary formulation of PSMA-11, a novel imaging agent targeting prostate-specific membrane antigen (PSMA). It was originally developed by the Heidelberg group of the Deutsches Krebsforschungszentrum.

The cold kit format of TLX591-CDx enables rapid radiolabelling at room temperature with high radiochemical purity and production consistency, optimised for the radiopharmacy setting.

What was today’s update?

This morning Telix revealed that it has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for TLX591-CDx.

This NDA submission includes clinical data from over 600 patients obtained from both prospective and retrospective clinical studies. It also builds on definitive peer-reviewed clinical research conducted at leading academic centres. These include the University of California, the Peter MacCallum Cancer Centre in Australia, and the Heidelberg University Hospital in Germany.

A significant milestone.

Telix USA President, Dr Bernard Lambert, commented: “We are pleased to have achieved this significant milestone with the submission of the first commercial NDA for PSMA imaging in the United States.”

“Telix has engaged with the FDA since July 2019, with valuable guidance resulting in what we believe to be a comprehensive submission. Subject to FDA approval, we look forward to bringing this product to market with our commercial partners to serve the needs of men living with prostate cancer,” he added.

Telix’s CEO, Dr Christian Behrenbruch, believes this submission is a “major commercial inflection point” for the company.

“The Telix team and our advisors have done an outstanding job of preparing this submission, which we believe is founded on compelling clinical evidence that supports broad diagnostic utility in the management of prostate cancer,” Dr Behrenbruch concluded.

No date has been given for when an FDA decision is likely to be announced.

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Motley Fool contributor James Mickleboro owns shares of TELIXPHARM DEF SET. The Motley Fool Australia has no position in any of the stocks mentioned. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

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