Telix Pharmaceuticals

FDA accepts Telix Pharmaceuticals' new drug application for glioma-imaging agent Pixclara (TLX101-CDx), granting priority review with a decision deadline of April 26, 2025. Pixclara, already with orphan drug and fast track designations, targets LAT and LAT2 proteins in solid tumors, potentially improving brain cancer imaging in the U.S.

FDA grants priority review to Telix Pharmaceuticals' Pixclara (18F-FET) for brain cancer imaging, aiming to fill the U.S. gap in targeted amino acid PET agents by 2025. Pixclara designated as orphan drug, also under review as companion diagnostic for TLX101-Tx, addressing MRI limitations in glioma diagnosis.

Telix Pharmaceuticals' brain cancer diagnostic, Pixclara, could be its second commercial product, with FDA acceptance of its NDA. Rhythm Biosciences aims to replace the bowel cancer 'poo test' with its Colostat assay. Quarterly reports indicate sector growth, with Telix, Respiri, and Biome Australia showing positive financials.

Telix Pharmaceuticals' TLX101-CDx (Pixclara) for glioma imaging has received priority review from the US FDA, with a PDUFA goal date of 26 April 2025. Pixclara, designated an orphan drug and granted fast-track status, aims to address unmet needs in glioma diagnosis and management, offering precision imaging over conventional MRI limitations. Telix is also exploring Pixclara's use as a companion diagnostic for TLX101-Tx, a neuro-oncology drug in development.

The FDA accepted Telix Pharmaceuticals' drug application for a glioma imaging agent, TLX101-CDx (Pixclara), granted priority review, potentially enabling a 2025 US launch. Pixclara aims to aid in diagnosing and managing glioma tumors in adults and children, addressing the lack of FDA-approved imaging agents for brain cancer in the US.

Companies are developing radiolabeled antibody-drug conjugates (rADCs) to target cancer cells directly, reducing side effects and treatment times. rADCs, which use antibodies to deliver radiation to cancer cells, are seen as an emerging modality in oncology. Despite challenges like supply and delivery hurdles, clinical trials are progressing, with promising interim results and FDA orphan drug designations.

Health Canada approves Illuccix for selecting mCRPC patients for PSMA-targeted radionuclide therapy with 177Lu-PSMA-617. Illuccix, initially approved in Canada in 2022 and the US in 2021, aids in staging and re-staging prostate cancer and localizing tumor tissue. The VISION trial data supported FDA approval of 177Lu-PSMA-617 in 2022, showing improved PFS and OS in PSMA-positive mCRPC patients.

Health Canada expands Telix Pharmaceuticals’ Illuccix use for identifying mCRPC patients eligible for PSMA-targeted therapy, enhancing its clinical applications across 265 Canadian hospitals and clinics.

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The first patient has been dosed in the phase 2 CA-NINE trial comparing TLX250-CDx PET/CT to conventional imaging for detecting recurrent clear cell renal cell carcinoma (ccRCC) post-surgery. TLX250-CDx targets carbonic anhydrase IX (CAIX) and showed high sensitivity and specificity in the phase 3 ZIRCON trial. The CA-NINE trial aims to enroll 91 patients, with primary completion expected by December 2029. Telix seeks FDA approval for TLX250-CDx, addressing sterility concerns in the BLA submission.