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

An executive in a suit smooths his hair and laughs as he looks at his laptop feeling surprised and delighted.
Share Gainers

Why APA, Aurelia Metals, Magnetic Resources, and ResMed shares are rising today

These shares are avoiding the market selloff on Tuesday.

Read more »

Fancy font saying top ten surrounded by gold leaf set against a dark background of glittering stars.
Share Gainers

Here are the top 10 ASX 200 shares today

It was a positive start to the week for ASX investors.

Read more »

Shot of a young businesswoman looking stressed out while working in an office.
Share Gainers

Why Johns Lyng, Qantas, St Barbara, and Super Retail shares are falling today

These shares are starting the week in the red. But why?

Read more »

Overjoyed man celebrating success with yes gesture after getting some good news on mobile.
Share Gainers

Why ALS, Life360, Nuix, and Sovereign Metals shares are pushing higher today

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

Read more »

A man looking at his laptop and thinking.
Share Gainers

Here are the top 10 ASX 200 shares today

It was a horrid end to the trading week this Friday.

Read more »

Three people jumping cheerfully in clear sunny weather.
Share Gainers

3 ASX 200 stocks rocketing higher this week even as the market dives

These three ASX 200 stocks are shrugging off the wider market sell-off this week to leap higher.

Read more »

Ecstatic man giving a fist pump in an office hallway.
Share Gainers

Why Insignia, Meteoric Resources, Qantas, and West African shares are pushing higher today

These shares are avoiding the market selloff today.

Read more »

Unsure man analysing data on laptop.
Share Gainers

Here are the top 10 ASX 200 shares today

The ASX suffered another fall this Thursday.

Read more »