Telix and FDA Agree on Resubmission Pathway for TLX101-CDx (Pixclara®) U.S. NDA
Melbourne (Australia) and Indianapolis, IN (U.S) | 9 September 2025
Telix today announces that it has reached agreement with the United States (U.S.) Food and Drug Administration (FDA) regarding resubmission of its New Drug Application (NDA) for TLX101-CDx (Floretyrosine F18 or 18F-FET, Pixclara®[1]), an investigational agent for the imaging of glioma, a rare and life-threatening brain cancer. As previously advised, the Company confirms its plan to resubmit the NDA during Q4 2025[2].
Following engagement with the FDA, including a successful Type A meeting, Telix has received detailed feedback regarding a resubmission package which will include an additional confirmatory efficacy study analysis of existing data. Based on this feedback, Telix believes the study will meet the FDA’s request for additional confirmatory evidence to supplement the NDA and address the review matters cited in the Complete Response Letter (CRL).
Dr. David N. Cade, Telix Group Chief Medical Officer, said, “As previously advised, Telix had multiple options for delivering additional data requested by the FDA in the CRL response[3]. This flexibility has enabled us to work with relative speed to reach a mutually agreed path forward for resubmission of the NDA. We remain steadfastly focused on our goal of bringing this important imaging agent to patients in the U.S. to support improved diagnosis and management of glioma”.
The FDA will advise of a new PDUFA[4] goal date following a successful resubmission. The agency has acknowledged the unmet medical need and has indicated that an expedited review is likely to be granted on this basis, subject to submission review.
TLX101-CDx is not included in Telix’s stated revenue guidance for 2025, as guidance excludes revenue forecasts from unapproved products[5]. The Company remains committed to providing ongoing patient access to TLX101-CDx through the FDA-approved expanded access program (EAP)[6] up until U.S. regulatory approval.
[1] Provisional brand name, subject to final regulatory approval.
[2] Telix ASX disclosure 21 August 2025, noted resubmission planned in approximately three months
[3] Telix ASX disclosure 28 April 2025.
[4] Prescription Drug User Fee Act.
[5] Telix ASX disclosure 20 February 2025.
[6] ClinicalTrials.gov ID: NCT06743100.
TLX101-CDx has not received a marketing authorization in any jurisdiction.