Telix Pharmaceuticals Ltd ADR Stock Price, News & Analysis

Telix Pharmaceuticals (NASDAQ: TLX) has achieved a significant milestone as the U.S. Centers for Medicare & Medicaid Services (CMS) granted Transitional Pass-Through (TPT) payment status for Gozellix®, its next-generation PSMA-PET imaging agent for prostate cancer.

The TPT status, effective October 1, 2025, enables separate reimbursement under the Hospital Outpatient Prospective Payment System and eliminates the 20% patient coinsurance. Gozellix® features an extended six-hour shelf life and broader distribution radius compared to existing gallium-based products. The agent can be prepared via both gallium generators and cyclotron-based methods, offering improved efficiency and scheduling flexibility for scanning clinics.

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) announced its participation in two upcoming healthcare investment conferences. CEO Dr. Christian Behrenbruch will participate in fireside chats at the Morgan Stanley Global Healthcare Conference on September 8, 2025, at 4:50 p.m. ET and the H.C. Wainwright Global Investment Conference on September 9, 2025, at 12:00 p.m. ET.

Both conferences will be held in New York, with sessions available via live webcast and on-demand through the company's investor relations website.

Telix Pharmaceuticals (ASX/NASDAQ: TLX) reported strong H1 2025 financial results, with revenue surging 63% to $390.4 million. The company achieved an Adjusted EBITDA of $21.1 million despite increased operating expenditure from strategic acquisitions and R&D investments.

Key highlights include a group gross profit margin of 53%, R&D investment of $81.6 million (up 47% YoY), and positive operating cash flow of $17.7 million. The Precision Medicine segment saw 30% revenue growth, while RLS Radiopharmacies contributed $109.5 million in revenue. The company maintains its FY 2025 revenue guidance of $770-800 million.

Telix achieved significant pipeline milestones, including completion of Phase 3 enrollment for TLX591 in prostate cancer and regulatory approvals for multiple therapeutic programs.

Telix Pharmaceuticals (ASX/NASDAQ: TLX) has announced it will release its financial results for H1 2025 on August 21, 2025. The company will host an investor webcast and conference call at 9:30 AM AEST (7:30 PM EDT on August 20, 2025) to discuss the results.

Investors can access the presentation through a webcast link or join via teleconference, with registration required for both options.

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.

Telix Pharmaceuticals (NASDAQ: TLX) has achieved a significant milestone as its prostate cancer imaging agent Gozellix received a permanent Healthcare Common Procedure Coding System (HCPCS) code from CMS. The code A9616, effective October 1, 2025, will facilitate provider billing and reimbursement processes.

Gozellix is a PSMA PET imaging agent used for detecting prostate cancer metastasis in initial therapy candidates and patients with suspected biochemical recurrence. The product features an extended shelf-life and flexible production options, addressing historical logistical barriers in PSMA-PET imaging access.

The HCPCS code represents a crucial step toward obtaining Transitional Pass-Through payment status and expanding commercial accessibility of PSMA PET imaging across the United States.

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 has launched AlFluor™, a novel PET radiochemistry platform enabling flexible radiolabeling of PSMA with either AlF or gallium-68. The platform combines 18F imaging benefits with 68Ga kit-based workflow convenience, supporting both centralized cyclotron manufacturing and distributed kit production. Telix has partnered with University Hospital Ghent for [18F]AlF-PSMA-11, including exclusive access to Phase 3 trial data involving 96 prostate cancer patients. The trial showed diagnostic performance comparable to commercial 68Ga-labeled PSMA-11 agents, with high specificity for metastatic detection. The technology can potentially be used with ligands targeting NETs and FAP, along with other imaging agents under development.