Telix Pharmaceuticals

Telix Pharmaceuticals' brain cancer imaging agent Pixclara (TLX101-CDx) received a rejection from the FDA, which requested additional clinical evidence before approval.

• Preliminary results from the phase 2 IPAX-Linz study demonstrate TLX101 (131I-iodofalan) achieved a median overall survival of 12.4 months from treatment initiation in recurrent high-grade glioma patients. • The targeted radiation therapy was well-tolerated with no serious adverse events reported, even at higher doses than previous studies, suggesting potential for dose escalation in future trials. • TLX101 showed efficacy despite challenging patient characteristics, including MGMT unmethylated tumors, offering new hope for a patient population with historically poor outcomes.

Novo Nordisk undergoes significant executive restructuring following the departure of EVP Camilla Sylvest, with rare disease leader Ludovic Helfgott taking over expanded commercial strategy responsibilities.

Telix Pharmaceuticals has dosed the first patient in its Phase 1 ZOLAR trial evaluating TLX300-CDx (89Zr-olaratumab) in patients with advanced soft tissue sarcoma at Melbourne Theranostic Innovation Centre.

The U.S. Food and Drug Administration has granted approval for Telix Pharmaceuticals' new drug application for their prostate cancer imaging agent, offering improved diagnostic capabilities for clinicians.

Heidelberg Pharma's lead ATAC candidate HDP-101 demonstrated safety and tolerability in cohort 7 at 112.50 µg/kg dose for multiple myeloma, with a patient from cohort 5 maintaining complete remission.

Telix Pharmaceuticals has completed the acquisition of Fibroblast Activation Protein (FAP)-targeting theranostic candidates from Johannes Gutenberg-Universität Mainz, adding TLX400 to its pipeline for bladder cancer and other solid tumors.

Heidelberg Pharma and HealthCare Royalty have amended their royalty financing agreement, providing an immediate $20 million payment to Heidelberg while restructuring future milestone payments.

• Telix Pharmaceuticals will showcase four presentations at ASCO GU 2025, including preliminary data from the CUPID study demonstrating proof-of-concept for their alpha therapy candidate in prostate cancer. • The company's Phase 3 ProstACT GLOBAL trial investigating TLX591 for PSMA-positive metastatic castration-resistant prostate cancer is actively enrolling patients across multiple regions. • Two groundbreaking STARLITE trials will present updates on TLX250 combined with immunotherapy for clear cell renal cell carcinoma, positioning it as the first potential CAIX-targeting radiotherapy.

Telix Pharmaceuticals' Illuccix receives European marketing authorization for prostate cancer imaging, following a positive decision via decentralized procedure.