Illuccix

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Telix Pharmaceuticals Limited (TLX) Increases R&D by 47%, Progresses Key Prostate and Brain Cancer Trials
Yahoo Finance· 2025-09-18 14:40
Core Insights - Telix Pharmaceuticals Limited is recognized as one of the most oversold healthcare stocks in 2025, focusing on precision oncology and targeted radiotherapies with active clinical programs in prostate cancer and rare oncologic conditions [1] Financial Performance - In the 2025 half-year update, Telix reported a 30% revenue increase in its Precision Medicine segment, driven by strong demand for its PET imaging agent, Illuccix, and the launch of new products like Gozellix, Zircaix, and Pixclara in international markets [2] - The company has expanded its manufacturing capabilities through Telix Manufacturing Solutions to support clinical and commercial operations globally [2] Research and Development - Telix increased its R&D spending by 47% year-over-year to $81.6 million, continuing to invest in its therapeutics pipeline despite being oversold [3] - Key milestones include the completion of target enrollment for the Phase 3 TLX591 trial in advanced metastatic castration-resistant prostate cancer (mCRPC), initiation of a Phase 1 trial for TLX592, and the start of the pivotal IPAX BrIGHT trial for TLX101 in metastatic brain cancer [3][4] - The company also gained IND approval for a Phase 1 study of TLX090 to manage bone pain in osteoblastic metastatic disease [3] Strategic Positioning - Diagnostic growth is further supported by the dosing of the first patient in the pivotal Phase 3 BiPASS trial, aimed at expanding indications for Illuccix and Gozellix in prostate cancer imaging [4] - Telix's dual strategy of commercial expansion and clinical innovation positions it as a leader in radiopharmaceuticals and precision oncology globally [4]
Telix Reports $204M Revenue, Up 63% YOY
Globenewswire· 2025-07-22 08:06
Core Insights - Telix Pharmaceuticals reported a significant increase in Q2 2025 revenue, reaching approximately $204 million, a 63% increase year-over-year, and reaffirmed its FY 2025 revenue guidance of $770 million to $800 million [3][6][22]. Financial Performance - Group revenue for Q2 2025 was $204 million, compared to $125 million in Q2 2024, marking a 63% increase. Revenue for Q1 2025 was $186 million, showing a 10% increase quarter-over-quarter [3][6]. - Global Illuccix® revenue was $154 million in Q2 2025, up 25% from $123 million in Q2 2024, and slightly increased by 2% from $151 million in Q1 2025 [3]. - RLS revenue reached $46 million in Q2 2025, with no revenue reported in Q2 2024, and a 39% increase from $33 million in Q1 2025 [3]. Business Highlights - Dose volumes for Illuccix rose 7% quarter-on-quarter in the U.S., indicating strong market demand despite competitive pricing pressures [4]. - The launch of Gozellix in the U.S. has commenced, with the product assigned a Level II HCPCS code, a key step towards reimbursement [6]. - The ProstACT Global Phase 3 trial achieved a milestone with all 30 patients consented for Part 1, and the trial is expanding into China, Japan, and Canada [7]. Therapeutics Development - TLX591 (Lu-rosopatamab tetraxetan) is progressing in its Phase 3 trial, with dosing completed for patients in two of the three arms [7]. - TLX592 (Ac-PSMA-RADmAb) has submitted an application for a Phase 1 study in Australia [7]. - TLX101 (I-iodofalan) received HREC approval in Australia for an international pivotal trial [7]. - TLX250 (¹⁷⁷Lu-DOTA-girentuximab) is enrolling patients in a Phase 1b/2 clinical trial for clear cell renal cell carcinoma [7]. Regulatory and Corporate Updates - Telix is cooperating with the U.S. SEC regarding a subpoena for documents related to its prostate cancer therapeutic candidates [11][12]. - The company has received country-level approvals for Illuccix in multiple European countries and is launching on a market-by-market basis [13]. - Telix has completed enrollment for the Illuccix China Phase 3 study, aiming for marketing authorization in Q4 2025 [13]. Manufacturing and R&D - Telix announced a GMP manufacturing facility in Yokohama, Japan, enhancing its global manufacturing strategy [14]. - The TMS facility in Brussels South, Belgium, has produced its first GMP commercial radiopharmaceutical doses [14]. - The company expects a 20% to 25% increase in R&D expenditure for FY 2025 compared to FY 2024 [22].