Telix Pharmaceuticals Limited (TLX) announced that it has resubmitted the NDA to the United States Food and Drug Administration or FDA for its investigational imaging agent TLX101-Px(Pixclara, Floretyrosine F 18 or 18F-FET) for recognizing recurrent or progressive glioma or brain cancer from treatment-related changes in both adult and pediatric patients.
Gliomas are very diffusely infiltrative tumours that affect the surrounding brain tissue. In the U.S., there are six cases per 100,000 people diagnosed with of gliomas every year.
TLX101-Px (Pixclara) is a PET imaging agent that has been granted fast-track and orphan drug designations by the FDA for the characterisation of recurrent or progressive glioma in the context of treatment-related changes.
Telix has resubmitted the NDA with the additional data requested by the FDA during the the earlier complete response letter(CRL) received from FDA for TLX101-Px in April 2025.
As per the CRL received earlier, FDA stated additional confirmatory clinical evidence is required to progress the application.
After the resubmission with additional data, Now Telix believes that based on the Type A meeting and ongoing consultation with the FDA and statistical analysis, along with the primary data set provided in the original submission, it has appropriately addressed the CRL.
"Our resubmission is supported by an extensive and compelling data set ", said Dr David N. Cade, Telix Group Chief Medical Officer.
Notably, Telix has filed a marketing authorisation application for TLX101-Px in Europe.
For the full year 2025,Telix incurred a loss before tax of $5.3 million from profit before tax of $38 million in the prior year.
Telix revenue jumped 56 percent to $803.8 million from $516.6 million in the prior year. Telix reported a year-end cash balance of $141.9 million.
For the full year 2026, Telix provided group revenue guidance to be in the range of $950 million and $970 million, higher from $803.8 million in 2025.
TLX has traded between $6.28 and $20 in the last year. The stock closed Friday's trade at $7.85, down 0.51%.
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