Shares in Telix Pharmaceuticals Ltd (ASX: TLX) were trading higher on Wednesday after the company said it had filed a key regulatory approval in Europe.
Telix, in a statement to the ASX, said it had submitted a marketing authorisation application (MAA) in Europe for its brain cancer imaging candidate, TLX101-Px.
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Dual regulatory process on foot
The company said it had been preparing the regulatory packages for Europe and the US concurrently and was "bringing forward the European submission to meet an agreed filing date while aligning with aspects of the U.S. Food and Drug Administration (FDA) package to support the additional application''.
The new submission covers the major European markets, Telix said.
The company added:
In Europe, positron emission tomography (PET) imaging of glioma with 18F-FET (FET-PET) is currently performed under physician-supervised use through hospital-based production at a limited number of sites. However, there is currently no generally available commercial product in Europe that ensures consistent quality and access for glioma imaging, an acute and immediate need. Telix aims to expand patient access to advanced imaging that can distinguish progressive or recurrent glioma from treatment-related changes in both adults and children, with potential for additional future indications.
Telix said the drug was also being developed as a patient selection and response assessment tool for its glioblastoma therapy candidate, "which has been granted orphan drug designation in Europe and the U.S. and is the subject of the Phase 3 IPAX-BrIGHT trial in patients with recurrent glioblastoma, launching in multiple European countries''.
Telix Precision Medicine Chief Executive Officer Kevin Richardson said:
We see a compelling opportunity in Europe to broaden access to authorized targeted radiopharmaceuticals for brain cancer imaging and therapy, and as such this submission is an important milestone for Telix. The strategic value of this submission is particularly relevant to establishing widespread glioma imaging as part of our corresponding therapeutic development program. We have been able to utilize aspects of our FDA package to expedite the European filing, which has been submitted in accordance with a pre-defined date agreed with the regulator, with the U.S. resubmission to follow.
Telix shares were trading 2.8% higher on the news on Wednesday morning. The company's shares are not far off their 12-month lows of $8.26 and well below the highs of $31.97 achieved about a year ago.
Some brokers believe the stock is undervalued, with Citi reiterating its buy rating on the stock with a price target of $34.
Telix was valued at $2.99 billion at the close of trade on Tuesday.
