The Telix Pharmaceuticals Ltd (ASX:TLX) share price is jumping higher on Tuesday after providing an FDA update…
The post Telix (ASX:TLX) share price jumps 8% higher on FDA update appeared first on Motley Fool Australia. –
The Telix Pharmaceuticals Ltd (ASX: TLX) share price has been a strong performer on Tuesday.
In morning trade the clinical-stage biopharmaceutical company’s shares jumped 8% to $1.78.
This leaves the Telix share price within sight of its 52-week high of $1.95.
Why is the Telix share price charging higher today?
Investors have been buying Telix’s shares this morning after it announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for 18F-FET for the positron emission tomography (PET) imaging of glioma. This is a type of brain tumour.
According to the release, the granting of this ODD qualifies Telix for various drug development incentives. These may include FDA-administered market exclusivity for seven years, waived FDA prescription drug user fees, and tax credits for R&D and clinical development costs.
What is glioma?
Gliomas comprise a group of primary brain tumours arising from glial cells which surround and support the neurons of the brain.
The company notes that there are over 22,000 cases in the United States each year and represent over 80% of all malignant brain tumours.
Telix’s CEO, Dr Christian Behrenbruch, commented, “PET imaging of the brain is increasingly used to supplement conventional imaging with MRI, which for many years has been the primary clinical imaging modality in patients with glioma at all stages of disease.”
“The granting of an Orphan Drug Designation by the FDA for 18F-FET provides Telix with the option to develop this valuable PET imaging agent commercially, to ensure it is available to patients with glioma across the disease spectrum,” he added.
In addition to this, management notes that 18F-FET is highly suitable for use as a companion diagnostic to TLX101. This is Telix’s therapeutic drug candidate for treating glioblastoma, a highly aggressive form of glioma.
In light of this, Mr Behrenbruch believes “18F-FET’s relevance as a patient selection and therapeutic monitoring tool for TLX101 is particularly beneficial to the Company.”
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Motley Fool contributor James Mickleboro owns shares of TELIXPHARM DEF SET. 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.