Telix Pharmaceuticals announced positive Phase 3 Part 1 data for TLX591-Tx, a lutetium radio antibody-drug conjugate for metastatic castration-resistant prostate cancer. The study of 36 patients showed acceptable safety and tolerability when combined with standard-of-care therapies, with no new safety signals. Radiation exposure remained below established safety limits, and the company has initiated Part 2 randomized expansion in multiple jurisdictions.

Telix Pharmaceuticals announced completion of patient enrolment in the IPAX-2 Phase 1 study of TLX101-Tx (¹³¹I-iodofalan) for newly diagnosed glioblastoma. The study reached its maximum dose of 10GBq with no dose-limiting toxicities observed. The company is also advancing the pivotal IPAX BrIGHT Phase 3 trial for recurrent glioblastoma, marking the first radiopharmaceutical therapy to enter Phase 3 development for this indication.

Regeneron Pharmaceuticals' stock dropped 10.20% in premarket trading after its Phase 3 melanoma trial failed to meet its primary endpoint. While the high-dose fianlimab combination showed numerically higher progression-free survival (11.5 months vs 6.4 months), it missed statistical significance with a p-value of 0.0627. The company also announced a partnership with Telix Pharmaceuticals to develop radiopharmaceutical therapies.

Telix Pharmaceuticals announced publication of Phase 3 ZIRCON trial data showing that TLX250-Px PET/CT imaging may be effective in diagnosing not only clear cell renal cell carcinoma (ccRCC) but also non-clear cell renal cell carcinoma (nccRCC), with a 98% positive predictive value for malignancy. The exploratory analysis suggests broader clinical applications beyond the original ccRCC focus, potentially aiding in risk stratification and treatment decisions for renal cancer patients.

Telix Pharmaceuticals announced that its marketing authorization application (MAA) for TLX101-Px, a PET imaging candidate for glioma (brain cancer), has been validated and accepted for review in Europe. The application has entered a 210-day active assessment phase, with national marketing authorizations expected to follow a positive outcome. The product addresses a critical unmet need in Europe where no commercial FET-PET imaging product currently exists for glioma diagnosis and treatment monitoring.

Telix Pharmaceuticals announced dosimetry results from the Phase 2 OPTIMAL-PSMA trial of TLX597-Tx, a PSMA-targeting radioligand therapy for metastatic castration-resistant prostate cancer. The trial demonstrated low salivary gland and kidney uptake, supporting dose intensification and improved tolerability. Telix is initiating OPTIMAL-E, a Phase 2 study in earlier-stage metastatic hormone-sensitive prostate cancer, as part of its portfolio approach alongside TLX591-Tx.

Telix Pharmaceuticals announced an educational webinar scheduled for April 30, 2026 (AEST) featuring Dr. David N. Cade and Professor Louise Emmett discussing the evolution of PSMA-targeted radionuclide therapy and Telix's multi-product approach to prostate cancer treatment. The webinar will showcase data from the OPTIMAL-PSMA2 trial of TLX597-Tx (177Lu-DOTA-PSMA), Telix's novel second-generation small molecule candidate for lutetium therapy.

Telix Pharmaceuticals and Regeneron Pharmaceuticals announced a collaboration to develop next-generation radiopharmaceutical therapies for solid tumors. Telix will receive $40 million upfront plus up to $2.1 billion in milestone payments and royalties. The partnership combines Telix's radiopharmaceutical platform with Regeneron's biologics expertise. Telix also reported Q1 revenue of $230 million (up 11% sequentially) and reaffirmed its 2026 guidance of $950-970 million. Additionally, the FDA accepted Telix's resubmitted application for Pixclara for brain cancer imaging.

The FDA has accepted Telix Pharmaceuticals' resubmitted New Drug Application for TLX101-Px1 (Pixclara), a PET imaging agent for glioma characterization, with a PDUFA goal date of September 11, 2026. The drug has received Orphan Drug and Fast Track designations and addresses a significant unmet medical need in distinguishing tumor progression from treatment-related changes in brain cancer patients.

Telix Pharmaceuticals announced the appointment of two experienced Non-Executive Directors effective May 11, 2026: Maria Rivas, MD, a former Pfizer Chief Medical Officer with 25+ years in pharmaceutical development, and William Jellison, a corporate finance leader with 30+ years experience and current board positions at Medtronic and other major companies. The appointments are part of the company's board expansion and succession planning as it evolves into a dual-listed, global, commercial-stage biopharmaceutical company.

Telix Pharmaceuticals reported Q1 2026 unaudited group revenue of US$230 million, up 11% quarter-over-quarter, with Precision Medicine revenue reaching US$186 million (up 16% QoQ). The company reaffirmed FY 2026 revenue guidance of US$950-970 million. Key highlights include successful completion of Part 1 of the ProstACT Global Phase 3 study for TLX591-Tx prostate cancer therapy, NDA resubmission for TLX101-Px brain cancer imaging candidate, and MAA filing in Europe. The company also announced the appointment of David Gill as Non-Executive Director.

Telix Pharmaceuticals announced the appointment of David Gill as Non-Executive Director effective May 11, 2026, with plans to appoint him as Chair succeeding Dr. Mark Nelson. Gill brings over 35 years of life sciences executive experience, including CFO and President roles at multiple publicly traded companies, and expertise in capital markets, business scaling, and governance.