Why the Telix (ASX:TLX) share price is surging 8%

The Telix share price is surging higher today after the company announced an FDA approval for its prostate cancer imaging product.
The post Why the Telix (ASX:TLX) share price is surging 8% appeared first on Motley Fool Australia. –

rising medical asx share price represented by FDA approval stamp

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.

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.

Where to invest $1,000 right now

When investing expert Scott Phillips has a stock tip, it can pay to listen. After all, the flagship Motley Fool Share Advisor newsletter he has run for more than eight years has provided thousands of paying members with stock picks that have doubled, tripled or even more.*

Scott just revealed what he believes are the five best ASX stocks for investors to buy right now. These stocks are trading at dirt-cheap prices and Scott thinks they are great buys right now.

See The 5 Stocks

*Returns as of June 30th

More reading

Motley Fool contributor Aaron Teboneras has no position in any of the stocks mentioned. 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.

The post Why the Telix (ASX:TLX) share price is surging 8% appeared first on Motley Fool Australia.

Trade The World Anywhere & Anytime!

Mobile app platform with over 50,000 global listed securities across 12 markets (over 70% global market capitalisation), right from your Android or iOS device.

Integrated with exclusive trading idea and investment analysis tools to help you find actionable insight on virtually every financial instrument across our 12 global markets, to help you optimise your trading strategies.

Refer Your Friends

Tell your friends about Monex and gift them FREE access to our trading tools.

We respect your privacy and will only send this one email notification to your friends. 

Share With Your Friends

Share on facebook
Share on twitter
Share on linkedin

Monex Trading Tools Access and Usage Terms

The Monex Trading Tools (referred to as ‘tools’ hereafter) are available to you inside your client portal;

To activate access to the tools, you must have a verified and approved trading account and have made a deposit of at least AUD $1000.

An active and funded account with a positive trading balance is required to continue to have access to the tools;

Although the tools are available to you indefinitely, Monex Securities may at it’s discretion disable access to the tools in the future;

Monex securities reserves the right to change these terms and conditions from time to time, as it sees fit, without notice.

Important Notice
iOS & Android App - 12 International Markets & Over 70% Global Market Cap. $0 Brokerage On US Trades. Click Here!