Telix (ASX:TLX) share price lower despite key FDA update

This biopharmaceutical company is on the cusp of a major milestone…

| More on:
ASX share price movement represented by doctor pressing digitised screen with array of icons including one entitled health insurance,

Image source: Getty Images

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The Telix Pharmaceuticals Ltd (ASX: TLX) share price is edging lower on Thursday morning despite the release of a positive announcement.

At the time of writing, the biopharmaceuticals company's shares are down slightly to $5.61.

What did Telix announce?

The Telix share price is lower today despite providing an update on its U.S. Food and Drug Administration new drug application (NDA) review for its Illuccix product.

Illuccix is Telix's lead investigational product for prostate cancer imaging, which is a market management estimates to be worth US$900 million.

According to the release, the company has participated in a late-cycle review meeting with the FDA regarding the ongoing review of the NDA for the prostate cancer imaging investigational product.

Positively, during the meeting, the FDA indicated that there are no outstanding substantive review issues with Telix's submission.

Management commentary

Telix's Chief Executive Officer, Dr. Christian Behrenbruch, was pleased with the news.

He commented: "The late-cycle review meeting with the FDA continued a series of productive meetings with the Agency and sets the stage for the concluding phase of the NDA review process, including alignment on the final Illuccix product label."

Dr. Behrenbruch revealed that the company is now preparing itself for a potential launch if it gains approval.

"We remain optimistic about a positive outcome and, accordingly, are working closely with our commercial partners to prepare for the U.S. launch of Telix's lead product for prostate cancer imaging, pending approval. Delivering patient access to this important technology to support the management of prostate cancer remains a major corporate objective for Telix," he added.

The Telix share price has been a very strong performer over the last 12 months. Despite today's weakness, the Telix share price is now up a massive 325% since this time last year.

James Mickleboro owns Telix shares. The Motley Fool Australia's parent company Motley Fool Holdings Inc. 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.

More on Share Gainers

Man pointing an upward line on a bar graph symbolising a rising share price.
Share Gainers

Why Champion Iron, EBR Systems, Mesoblast, and Patriot Battery Metals shares are surging today

These shares are avoiding the market selloff on Thursday. But why?

Read more »

A man looking at his laptop and thinking.
Share Gainers

Here are the top 10 ASX 200 shares today

Investors ended up snatching defeat from the jaws of victory today.

Read more »

Excited group of friends sitting on sofa watching sports on TV and celebrating.
Share Gainers

Why Clarity, Omni Bridgeway, Santana Minerals, and Vulcan shares are pushing higher today

These shares are having a good time on hump day. But why?

Read more »

Man with rocket wings which have flames coming out of them.
Share Gainers

Guess which ASX All Ords stock just rocketed 44%

Investors are sending the ASX All Ords stock racing higher today. But why?

Read more »

A young boy wearing a hat, sunnies and striped singlet looks fierce and flexes his arm in victory.
Share Gainers

Here are the top 10 ASX 200 shares today

ASX shares finally caught a break this Tuesday.

Read more »

three businessmen high five each other outside an office building with graphic images of graphs and metrics superimposed on the shot.
Share Gainers

Why Novonix, PEXA, Tamboran Resources, and Westgold shares are storming higher

These shares are having a good time on Tuesday. Let's find out what's happening.

Read more »

Silhouettes of nine people climbing a steep mountain to the top at sunset, and helping each other along the way.
Share Gainers

Here are the top 10 ASX 200 shares today

The markets endured a rough start to the week this Monday.

Read more »

Man drawing an upward line on a bar graph symbolising a rising share price.
Share Gainers

Why 4DMedical, Brainchip, Meridian, and SCEE shares are rising today

These shares are having a strong start to the week. But why?

Read more »