Telix shares crash 8% on US FDA blow

This high-flying stock has been hit with some bad news.

| More on:
Shot of a young scientist looking stressed out while working on a computer in a lab.

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

Telix Pharmaceuticals Ltd (ASX: TLX) shares are tumbling on Monday morning.

At the time of writing, the radiopharmaceuticals company's shares are down 8% to $26.35.

Why are Telix shares sinking?

Investors have been selling the company's shares today after it was dealt a blow from the US Food and Drug Administration (FDA).

According to the release, Telix has received a Complete Response Letter from the FDA for its New Drug Application (NDA) for TLX101-CDx (Pixclara). It is an investigational agent for the imaging of glioma, a rare and life-threatening brain cancer.

Telix advised that the CRL states that the FDA has completed its review of the application and has ruled that the NDA cannot be approved in its current form.

The regulator has stated that additional confirmatory clinical evidence is required to progress the application, despite a robust consultation process prior to submission and during review of the NDA.

One positive is that the FDA has not raised any concerns regarding product safety.

What next?

Telix will now request a hearing with the regulator to review the basis for the decision and is assessing clinical strategies available to augment the package in the near term.

The company described the news as "a disappointing outcome for American glioma patients."

It highlights that FET-PET is recommended medical best practice in relevant international oncology practice guidelines and is used extensively in other parts of the world. The company also points out that the FDA has granted TLX101-CDx Orphan Drug and Fast Track designation. It believes this is a tacit acknowledgement of the drug candidate's importance in addressing a significant unmet medical need and clinically demonstrating benefit over existing medical solutions.

Commenting on the news, Telix's managing director and CEO, Dr. Christian Behrenbruch, said:

We are committed to commercializing TLX101-CDx and fulfilling the unmet need to improve imaging to enable timelier and more accurate decisions for the clinical management of glioma. We have multiple go-forward pathways available to us, such as providing additional confirmatory data through several active clinical programs, including Company-led studies.

Our immediate focus is understanding the FDA's feedback and augmenting our submission with additional data to satisfy the Agency as soon as possible.

Despite this blow, there is no change to the company's financial guidance for 2025. That's because its guidance excludes revenue forecasts from unapproved products.

The company also advised that it remains committed to providing patient access to TLX101-CDx through the FDA-approved expanded access program.

Motley Fool contributor James Mickleboro has no position in any of the stocks mentioned. The Motley Fool Australia's parent company Motley Fool Holdings Inc. has positions in and has recommended Telix Pharmaceuticals. The Motley Fool Australia has recommended Telix Pharmaceuticals. The Motley Fool has a disclosure policy. This article contains general investment advice only (under AFSL 400691). Authorised by Scott Phillips.

More on Healthcare Shares

a young woman holds her hand to her ear and leans sideways as if to listen to something that's surprising her as her eyes and her mouth are wide open.
Healthcare Shares

Down 15% since January, are Cochlear shares now a buy?

Let's see what analysts are saying about this blue chip.

Read more »

Green arrow with green stock prices symbolising a rising share price.
Healthcare Shares

Guess which popular ASX 200 stock is up nearly 60% in less than 2 months?

Investors who bought this ASX 200 stock in the recent dip have been strongly rewarded.

Read more »

A senior pharmacist talks to a customer at the counter in a shop.
Healthcare Shares

Are Sigma Healthcare shares a good buy now after the merger with Chemist Warehouse?

Sigma Healthcare shares have soared 154% in 12 months. Can this stellar run continue?

Read more »

Doctor doing a telemedicine using laptop at a medical clinic
Healthcare Shares

Up 34% since April, ASX 300 healthcare stock lifts off again today on new milestone

The ASX 300 healthcare stock has been on a tear since hitting one-year lows in April.

Read more »

Shot of a scientist using a computer while conducting research in a laboratory.
Healthcare Shares

Should I buy the dip on CSL shares?

A leading fund manager gives his verdict on the growth prospects for CSL shares.

Read more »

A woman relaxes on a yellow couch with a book and cuppa, and looks pensively away as she contemplates the joy of earning passive income.
Healthcare Shares

NIB shares have soared 24% this year. Does Macquarie expect this to continue?

Will this private health insurer continue to deliver big returns? Let's find out.

Read more »

Woman presenting financial report on large screen in conference room.
Healthcare Shares

Up nearly 30% in a year, should I buy Fisher & Paykel shares before its earnings result?

Will the ASX 200 healthcare stock continue to outperform?

Read more »

Cropped shot of an attractive young female scientist working on her computer in the laboratory.
Healthcare Shares

CSL shares among most expensive on ASX. Is now a good time to buy?

Analysts predict CSL share price growth will keep on coming.

Read more »