FDA Accepts Telix NDA for Glioma Imaging Agent TLX101-Px

Telix Pharmaceuticals ( (AU:TLX) ) has provided an update.

Telix Pharmaceuticals has had its resubmitted New Drug Application for TLX101-Px (Pixclara), an F-18 FET PET imaging agent for glioma, accepted by the U.S. FDA, which set a PDUFA goal date of September 11, 2026. The agent, already supported by international guidelines and granted Orphan Drug and Fast Track status, is intended to better distinguish recurrent or progressive glioma from treatment-related changes in adults and children, potentially improving care in a cancer type with poor prognosis and high recurrence.

Clinicians involved in neuro-oncology highlighted the current difficulty in differentiating tumor progression from treatment effects and welcomed the FDA’s move as a step toward broader U.S. access to FET-PET imaging. TLX101-Px also serves as a potential patient selection and response assessment tool for Telix’s LAT1-targeting therapeutic candidate TLX101-Tx in recurrent glioblastoma, underscoring the company’s broader precision medicine strategy, although Telix’s FY 2026 guidance currently assumes no revenue contribution from TLX101-Px.

The most recent analyst rating on (AU:TLX) stock is a Buy with a A$24.30 price target. To see the full list of analyst forecasts on Telix Pharmaceuticals stock, see the AU:TLX Stock Forecast page.

More about Telix Pharmaceuticals

Telix Pharmaceuticals is a global biopharmaceutical company specializing in radiopharmaceuticals for oncology and rare diseases, aiming to address significant unmet medical needs. Headquartered in Melbourne, it operates across the U.S., U.K., Brazil, Canada, Europe and Japan, and is listed on both the ASX and Nasdaq, reflecting its international commercial and investor focus.

Average Trading Volume: 3,200,050

Technical Sentiment Signal: Hold

Current Market Cap: A$4.73B

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