'Critical unmet need': Why everyone is talking about this ASX 200 healthcare stock

This healthcare stock has been given a boost from the US FDA today.

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Telix Pharmaceuticals Ltd (ASX: TLX) shares are rising on Tuesday.

In morning trade, the ASX 200 healthcare stock is up 1.5% to $13.08.

Why is the ASX 200 healthcare stock pushing higher?

Investors have been buying the company's shares after it revealed that the United States Food and Drug Administration (FDA) has granted Fast Track designation to one of its products.

According to the release, the FDA has granted the designation to its investigational glioma imaging product, TLX101- CDx.

The granted Fast Track designation is for the characterisation of progressive or recurrent glioma using positron emission tomography (PET). It provides the ASX 200 healthcare stock with an expedited review and closer consultation with the FDA during the review process.

Amino acid PET is currently included in U.S. and European guidelines for the imaging of gliomas, however, there is no FDA-approved targeted PET agent for brain cancer imaging.

Telix's goal is to make this product commercially available in the U.S., significantly increasing patient access to this important imaging agent.

The company also notes that, concurrently, it is in the final stages of preparing its U.S. New Drug Application (NDA) for TLX101-CDx in this initial indication, in both adult and paediatric patients.

'Critical unmet need'

Telix has an exclusive research collaboration and data license agreement with the University of California, San Francisco (UCSF). It is one of the leading academic centres conducting clinical research into the use of FET PET in a variety of neurological malignancies.

This academic-industrial collaboration supporting joint development and commercialisation will enable Telix to offer TLX101- CDx access as a commercial product in the U.S., subject to regulatory approval.

UCSF Professor of Radiology, Thomas A. Hope, MD, commented:

There is critical unmet need to improve the diagnosis and management of glioma, particularly in the post-treatment setting, and we are excited to leverage the clinical experience at UCSF to help make this investigational agent more widely available. 18F-FET has the potential to help determine if a glioma is truly progressing or undergoing a treatment-induced change, known as pseudo-progression, where MRI5 – the standard of care – can often be inconclusive.

Telix Chief Medical Officer, David N. Cade, MD, adds:

This unique collaboration between Dr. Hope's team at UCSF and Telix will enable us to utilise our collective clinical data and expertise to facilitate nationwide access to FET PET in the United States while fostering ongoing research and development with the objective of expanding the clinical utility of this advanced imaging agent for the benefit of patients.

Named as a buy

In other news, the ASX 200 healthcare stock was recently tipped as a buy by Medallion Financial Group according to The Bull.

In addition, Bell Potter currently has a buy rating and $14.50 price target on its shares and UBS has a buy rating and $18.50 price target on them.

Motley Fool contributor James Mickleboro has positions in Telix Pharmaceuticals. 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.

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