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Highlights

  • Telix has agreed with the FDA on a Q4 2025 NDA resubmission for TLX101-CDx, supported by additional confirmatory efficacy analysis.

  • The FDA signaled that expedited review is likely, subject to the resubmission meeting requirements.

  • TLX101-CDx remains available under the FDA Expanded Access Program, with revenue guidance excluding unapproved products.

Telix Pharmaceuticals Limited (ASX:TLX) (NASDAQ:TLX) has announced an agreement with the United States Food and Drug Administration (FDA) regarding the resubmission of its New Drug Application (NDA) for TLX101-CDx (Floretyrosine F18 or 18F-FET, Pixclara®). The investigational agent is designed for imaging glioma, a rare and aggressive brain cancer.

The company confirmed its plan to resubmit the NDA in Q4 2025. Following a successful Type A meeting with the FDA, Telix received detailed feedback outlining requirements for the resubmission. The package will include an additional confirmatory efficacy study analysis of existing data to address issues raised in the FDA’s prior Complete Response Letter (CRL).

The FDA indicated that, subject to review, an expedited evaluation is likely to be granted due to the significant unmet medical need in glioma imaging. A new Prescription Drug User Fee Act (PDUFA) goal date will be communicated by the FDA following resubmission.

Interim Patient Access and Revenue Guidance

While TLX101-CDx progresses through the regulatory process, Telix confirmed that the product will remain available to U.S. patients via the FDA-approved Expanded Access Program (EAP). This ensures ongoing access to the imaging agent until potential market authorization is granted.

Telix also highlighted that TLX101-CDx is excluded from its 2025 revenue guidance, as the company does not include contributions from unapproved products in its forecasts. The company’s financial outlook continues to be underpinned by its commercial and clinical-stage portfolio, including its approved imaging agents Illuccix® and Gozellix®.

Company Background and Global Presence

Telix Pharmaceuticals is a Melbourne-based biopharmaceutical company specializing in therapeutic and diagnostic radiopharmaceuticals and related medical technologies. The company operates internationally, with a presence in the United States, United Kingdom, Brazil, Canada, Europe, and Japan.

Telix’s portfolio spans oncology and rare diseases, targeting areas with significant unmet medical needs. Its first-generation PSMA-PET imaging agent, Illuccix®, has received approvals in multiple markets, while Gozellix® has been approved by the U.S. FDA. TLX101-CDx, however, has not yet been granted marketing authorization in any jurisdiction.