Telix Pharmaceuticals Ltd (ASX: TLX) shares are charging higher today.
Shares in the S&P/ASX 200 Index (ASX: XJO) diagnostic and therapeutic product developer closed yesterday trading for $13.64. In early morning trade on Friday, shares are changing hands for $14.14 apiece, up 3.7%.
For some context, the ASX 200 is down 0.6% at this same time.
With today's intraday lift factored in, Telix shares are now up an impressive 31.4% since market close on 11 March.
Here's what's piquing ASX investor interest today.
Image source: Getty Images
Telix shares jump on FDA acceptance
Telix shares are marching higher after the company announced that the United States Food and Drug Administration (FDA) has accepted its resubmitted New Drug Application (NDA) for TLX101-Px1.
TLX101-Px1, or Pixclara, is the company's glioma (brain cancer) imaging agent.
The FDA is aiming for a Prescription Drug User Fee Act (PDUFA) date on 11 September.
That date is achievable, as Pixclara holds both Orphan Drug and Fast Track designations in the US.
The company said that the FDA approval of Pixclara will help meet the significant unaddressed medical need for the characterisation of recurrent or progressive glioma from treatment-related changes in both adult and paediatric patients.
Telix noted that neuroimaging of glioma with 18F-FET (a radioactive imaging tracer) is already broadly recommended in international clinical practice guidelines.
FDA approval would open up the huge US medical market for Pixclara. However, Telix said it is not yet including any potential revenue from future sales in its full-year FY 2026 financial guidance.
What did management say?
"The FDA's acceptance of our NDA resubmission is an important milestone for Telix," Kevin Richardson, CEO Telix Precision Medicine, said. "We appreciate the FDA's constructive engagement and look forward to working closely with the Agency to urgently obtain approval and then bring this product to market for the benefit of patients."
Commenting on the FDA acceptance helping to boost Telix shares today, Thomas Hope – Vice Chair, Department of Radiology and Biomedical Imaging at the University of California, San Francisco – said:
There remains a critical unmet need in improving our ability to image residual glioma after treatment. We have worked with Telix for the last three years to help leverage our clinical data to help make FET-PET9 available to patients in the United States.
Patrick Wen, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, added:
Distinguishing tumour progression from treatment-related change remains one of the most challenging aspects of glioma care. PET imaging with 18F-FET is an important tool in clinical practice worldwide, and the FDA's acceptance of this application is a meaningful step toward broader access for patients and clinicians in the United States.
With today's intraday gains factored in, Telix shares remain down 46.8% over 12 months.
