- Telix Pharmaceuticals (TLX) has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for its prostate cancer imaging product, TLX591-CDx
- Telix’s new drug application includes clinical data compiled from over 600 patients
- The company has been working with the FDA since July 2019 to help submit a comprehensive application
- CEO Dr Christian Behrenbruch said submitting an NDA to the FDA is a major commercial inflection point for the company
- Telix ended the day up a slight 0.85 per cent to trade for $1.78
Telix Pharmaceuticals (TLX) has submitted a new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for its prostate cancer imaging product, TLX591-CDx.
TLX591-CDx technology targets Prostate-Specific Membrane Antigen (PSMA) for the imaging of prostate cancer using Positron Emission Tomography.
Telix’s NDA submission includes the clinical data from over 600 patients from clinical studies.
President for the U.S. branch, Dr Bernard Lambert, is happy with this milestone as it marks the company’s first commercial NDA for PSMA imaging in the U.S.
“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 said.
CEO Dr Christian Behrenbruch said submitting an NDA to the FDA is a major commercial inflection point for the company and follows the European submission earlier this year.
“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,” he said.
“I’d like to acknowledge the commitment of our investigators, study teams and the independent physician readers who contributed to our clinical data package,” he added.
On the market this afternoon, Telix is up 0.71 per cent and is trading for $1.77 per share at 3:58 pm AEST.