Telix Pharmaceuticals Ltd (ASX: TLX) shares are rocketing higher this morning after the company announced the United States Food and Drug Administration (FDA) approved its new drug application (NDA) for a prostate cancer imaging product. In early morning trade, the Telix share price is trading 8.1% higher at $3.07.
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NDA approval
Investors are driving up the Telix share price today after news that the FDA has accepted the company's NDA for TLX591-CDx (kit for the preparation of Ga-PSMA-11). The prostate cancer imaging product is a radiopharmaceutical targeting Prostate-Specific Membrane Antigen (PSMA). It uses a Positron Emission Tomography (PET) to scan for the disease.
Telix's NDA submission for its prostate cancer imaging product included clinical data from over 600 patients. These were obtained from the studies undertaken by Telix and its research partners. Additionally, clinical evidence was reported in peer-reviewed medical literature, which was conducted from leading global academic centres. The highly reputable group includes the University of California (United States), the Peter MacCallum Cancer Centre (Australia) and Heidelberg University Hospital (Germany).
About prostate cancer
Prostate cancer is the second most common cancer in men, after skin cancer. In 2018 alone, 1.3 million men were diagnosed with prostate cancer for the first time. Despite advances in treatment, prostate cancer still accounts for a large number of deaths. That same year, over 365,000 men died from the disease. As rates of diagnosis are improving, the highest number of incidents are occurring in Europe, the United States, Australia, and New Zealand.
What did management say?
Telix CEO, Dr Christian Behrenbruch, commented on the approved NDA. He said:
We are delighted to have achieved this significant milestone with the FDA's acceptance for filing of the first commercial NDA for PSMA imaging in the United States. This represents a major step towards our goal of providing this highly anticipated product to patients in the United States and beyond.
From acquiring ANMI4 and its advanced chemistry platform in December 2018, to successfully filing an NDA less than two years later, represents an extraordinary achievement by the Telix team. We now look forward to working with the FDA to bring TLX591-CDx to American patients living with prostate cancer as expeditiously as possible.
Furthermore, Telix Chief Medical Officer, Dr Colin Hayward, talked about the importance of the company's product, adding:
The use of Ga-PSMA PET imaging is rapidly becoming the standard of care for prostate cancer imaging across a broad range of clinical settings. PSMA imaging is already included in the leading clinical practice guidelines in the United States and Europe, based on evidence that definitively demonstrates superiority over conventional imaging.
Telix share price summary
Telix first listed on the ASX in November 2017. With today's rise, the Telix share price has hit a new, all-time high after notching up a previous high of $2.94 just last week. It was only at the start of November that the Telix share price jumped more than 30%. This came after news of the company's strategic partnership with China Grand Pharmaceutical and Healthcare Holdings (CGP) set a new record for the Telix share price.
