Telix Pharmaceuticals (NASDAQ: TLX) has hit a key clinical milestone, finishing patient enrollment in its Phase 3 Illuccix Japan study of TLX591‑Px for prosta

Completed enrollment of 105 patients in Phase 3 registration study of TLX591-Px (Illuccix®) for prostate cancer imaging in Japan. The study data will be used to support a New Drug Application (NDA) for TLX591-Px in Japan. MELBOURNE, Australia and TOKYO, July 17, 2026 /PRNewswire/ -- Telix Pharm...

Telix (ASX/NASDAQ: TLX) announced letters of intent to collaborate with EDAP and Profound Medical to explore investigational use of its PSMA-PET imaging agents Gozellix and Illuccix with minimally invasive, image-guided ablative therapies for localized prostate cancer, including robotic HIFU and MRI-guided TULSA.Initial work will focus on patient selection, treatment planning, post-treatment monitoring and clinical evidence generation to inform best practices and support emerging workflows aiming to preserve healthy tissue and reduce side effects.

MELBOURNE, Australia and INDIANAPOLIS, Jan. 16, 2026 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, “Telix”) today announces that the first patient in the United States (U.S.) has been dosed in BiPASS™ (Biopsy of the Prostate Avoidance Stratification Study), a Phase 3 trial to evaluate the use of Telix’s commercial PSMA-PET[1] imaging agents, Illuccix® (kit […]

Telix (TLX) announced the first U.S. patient has been dosed in BiPASS, a Phase 3 trial evaluating Illuccix and Gozellix 68Ga-PSMA-11 PET agents in the pre-biopsy prostate cancer diagnosis setting. The prospective, open-label study will enroll 250 patients across the U.S. and Australia and is designed to support marketing authorization for 68Ga-PSMA-PET in the pre-biopsy pathway. The trial will assess whether combining MRI with 68Ga-PSMA-11 PET improves diagnostic accuracy, reduces unnecessary biopsies (up to 75% of U.S. biopsies are reportedly negative), and enables better patient stratification and biopsy precision if objectives are met.

Telix (ASX/NASDAQ: TLX) announced a strategic clinical collaboration with Varian, a Siemens Healthineers company, on Dec 10, 2025 to develop integrated theranostics and external beam radiation therapy (EBRT) applications.The initial investigational focus is PSMA-PET imaging for prostate cancer, evaluating Gozellix and Illuccix to help select patients for EBRT, support personalized plans (including Varian Ethos adaptive radiotherapy), and monitor response. The agreement enables both company‑sponsored and investigator‑led clinical studies and is structured as a broad framework for future co‑development across Telix’s PET candidates including Zircaix (TLX250-CDx) and Pixclara (TLX101-CDx).Safety notes in the release highlight image interpretation limitations, radiation exposure risks, and adverse reaction data from studies (960 and 1003 patients) with mostly low rates of nausea, diarrhea, dizziness and fatigue.

Telix Pharmaceuticals (NASDAQ: TLX) has initiated its Phase 3 BiPASS clinical trial by dosing the first patient, aiming to expand indications for Illuccix® and Gozellix® in prostate cancer diagnosis. The study will evaluate if combining MRI and PSMA-PET imaging can improve diagnostic accuracy and potentially help patients avoid unnecessary biopsies.The trial will enroll 204 patients across Australia and the United States. The study builds upon promising research from PRIMARY and PRIMARY2 studies, which demonstrated benefits of combined imaging approaches. If successful, this could expand Telix's U.S. market for PSMA-PET imaging agents by approximately 800,000 scans, addressing a significant clinical need given that up to 75% of current prostate biopsies are negative.

Telix Pharmaceuticals (NASDAQ: TLX) reported strong Q2 2025 financial results with unaudited group revenue of $204 million, representing a 63% year-over-year increase. The company reaffirmed its FY 2025 revenue guidance of $770-800 million.Key highlights include the U.S. launch of Gozellix® with a Level II HCPCS code assignment, and significant progress in the ProstACT™ Global Phase 3 trial with all 30 patients consented for Part 1. Global Illuccix® revenue reached $154 million, up 25% year-over-year, while RLS revenue contributed $46 million.The company disclosed an ongoing SEC investigation regarding prostate cancer therapeutic candidates development disclosures, though this doesn't affect commercial products. Telix continues expanding globally with multiple regulatory approvals and advances across its therapeutic pipeline.

Gallium Ga-68 gozetotide injection is now indicated for use in PET imaging patient selection for radioligand therapy in the pre-taxane setting for mCRPC.

Reported Monday, Jun 23 - 7:38am EDT (TheFly subscription required to read more.)

The FDA has approved a label expansion for Telix Pharmaceuticals' (TLX) Illuccix, enabling its use for patient selection in radioligand therapy (RLT) in the pre-taxane setting. This expansion aligns with the recent FDA approval of Pluvicto for earlier use in metastatic castration-resistant prostate cancer patients. The clinical utilization of Illuccix is expected to increase by approximately 20,000 scans annually due to this development. Illuccix is used for PET imaging of PSMA-positive lesions in prostate cancer patients, helping identify those most likely to respond to PSMA-targeted therapy earlier in their treatment journey. The diagnostic tool has demonstrated safety in clinical studies involving over 1,900 patients, with minimal adverse reactions reported.

Telix Pharmaceuticals' Illuccix® PSMA-PET imaging agent has gained marketing authorization in Germany to assist in prostate cancer diagnosis, enhancing patient care.

MELBOURNE, Australia, June 5, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix", "the Company") today announces that its prostate cancer PET[1] imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted...

The Czech Republic’s State Institute for Drug Control has approved the Illuccix PSMA-PET imaging kit in adult patients with prostate cancer.

MELBOURNE, Australia, 5. toukokuuta 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, Yritys) ilmoittaa tänään, että sen PET[1]-kuvantamistutkimuksissa käytettävä eturauhassyövän Illuccix® (gallium-68 gotsetotidi-injekion valmistelupakkaus) -kuvantamisaine...

Telix Pharmaceuticals’ prostate cancer PET imaging kit Illuccix has received marketing authorization in France and Finland.

Telix Pharmaceuticals has received approval for its PSMA-PET imaging agent, Illuccix, in France, enhancing prostate cancer diagnosis capabilities in hospitals.