Illuccix Approved in U.S. for Patient Selection for Pre-Taxane RLT
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 23 2025
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Should l Buy TLX?
Source: Yahoo Finance
FDA Approval: The U.S. FDA has expanded the label for Telix Pharmaceuticals' Illuccix® to include patient selection for radioligand therapy in prostate cancer before chemotherapy, potentially increasing its clinical use by 20,000 scans annually.
Clinical Impact: This approval allows for earlier and more personalized treatment decisions for prostate cancer patients, enhancing the standard of care with PSMA-PET imaging for better identification of candidates for targeted therapy.
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Analyst Views on TLX
About TLX
Telix Pharmaceuticals Limited is an Australia-based biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. It is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Its segments include Therapeutics, Precision Medicine and Telix Manufacturing Solutions. Therapeutics segment develops targeted radionuclide therapies for urologic, neurologic, musculoskeletal and hematological cancers. Precision Medicine segment focuses on bringing diagnostic imaging solutions to market. Precision Medicine segment also includes MedTech and International businesses. Telix Manufacturing Solutions segment is its global network of facilities designed to deliver patient doses worldwide. Its pipeline products include TLX591, TLX250, TLX101, TLX66, TLX592, TLX252, TLX400, Illuccix (68Ga-PSMA-11) and TLX007-CDx.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Telix Pharmaceuticals to Release Full Year Results for 2025
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- Investor Conference: On the same day as the earnings release, Telix will hold an investor webcast and conference call at 9:30 a.m. AEDT, aimed at directly communicating the company's strategy and financial performance to investors.
- Global Business Presence: Telix operates in multiple countries including the U.S., U.K., Brazil, Canada, Belgium, Switzerland, and Japan, showcasing its extensive influence and market penetration in the biopharmaceutical sector, particularly in oncology and rare diseases.
- Forward-Looking Statements: The announcement includes forward-looking statements regarding Telix's R&D progress, clinical trials, and market strategies, which, despite uncertainties, provide investors with crucial insights into the company's future developments.
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- Significant Q4 Growth: The fourth quarter saw a 46% year-over-year revenue increase, totaling around $208 million, reflecting strong performance in the precision medicine sector, particularly following the successful launch of Gozellix.
- Clinical Research Progress: Telix dosed the first patient in the U.S. in the BiPASS Phase 3 trial, evaluating its PSMA-PET imaging agents for initial prostate cancer diagnosis, marking continued advancement in clinical research.
- Weak Stock Trend: Telix's stock has declined by 56.91% over the past 12 months, currently trading at $7.20, below both the 20-day and 100-day simple moving averages, indicating a bearish trend in the short term.
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- Precision Medicine Contribution: Revenue from the Precision Medicine segment rose to $161 million from $139 million a year ago, reflecting a 15.8% growth and highlighting the ongoing potential of this business line.
- RLS Third-Party Revenue: RLS third-party revenue reached $45 million, compared to zero last year, showcasing Telix's success in expanding partnerships and market share.
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- Overall Decline in Health Care Stocks: Late Friday afternoon, health care stocks broadly declined, with the NYSE Health Care Index easing 0.5%, reflecting a weakening market confidence in the sector that could impact short-term investor decisions.
- Market Sentiment Fluctuations: The drop in health care stocks may be linked to overall market sentiment fluctuations, as increased uncertainty regarding economic prospects leads to capital outflows from the health sector, affecting industry capital flows.
- Investor Focus Shift: As health care stocks decline, investors may reassess their portfolios, considering reallocating funds to other sectors with greater growth potential, which could impact capital inflows into the health industry.
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- Patient Recruitment Plan: The BiPASS™ trial aims to enroll 250 patients across the U.S. and Australia, seeking to enhance diagnostic accuracy by integrating MRI with PSMA-PET imaging, thereby reducing unnecessary biopsies and improving patient experience.
- Significant Market Potential: With over one million prostate biopsies performed annually in the U.S., of which up to 75% are negative, the success of BiPASS™ could drastically decrease biopsy rates and increase the adoption of PSMA-PET imaging, expanding the potential patient population.
- Industry Leadership: Telix CEO Kevin Richardson emphasized that the trial's initiation not only reflects the company's commitment to patient-centricity and clinical innovation but also aims to lower healthcare costs and risks by reducing invasive biopsies, further solidifying its leadership position in the industry.
See More
Telix Pharmaceuticals to Release Full Year Results for 2025
- Earnings Release Schedule: Telix Pharmaceuticals will release its full year results for the period ending December 31, 2025, on February 20, 2026, which is expected to provide key financial data and future outlook, assisting investors in evaluating the company's performance and market positioning.
- Investor Conference: On the same day as the earnings release, Telix will hold an investor webcast and conference call at 9:30 a.m. AEDT, aimed at directly communicating the company's strategy and financial performance to investors.
- Global Business Presence: Telix operates in multiple countries including the U.S., U.K., Brazil, Canada, Belgium, Switzerland, and Japan, showcasing its extensive influence and market penetration in the biopharmaceutical sector, particularly in oncology and rare diseases.
- Forward-Looking Statements: The announcement includes forward-looking statements regarding Telix's R&D progress, clinical trials, and market strategies, which, despite uncertainties, provide investors with crucial insights into the company's future developments.
See More
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- Revenue Target Achieved: Telix Pharmaceuticals reported FY 2025 revenue of approximately $804 million, aligning with its upgraded guidance of $800-$820 million, indicating stability and growth potential in the market.
- Significant Q4 Growth: The fourth quarter saw a 46% year-over-year revenue increase, totaling around $208 million, reflecting strong performance in the precision medicine sector, particularly following the successful launch of Gozellix.
- Clinical Research Progress: Telix dosed the first patient in the U.S. in the BiPASS Phase 3 trial, evaluating its PSMA-PET imaging agents for initial prostate cancer diagnosis, marking continued advancement in clinical research.
- Weak Stock Trend: Telix's stock has declined by 56.91% over the past 12 months, currently trading at $7.20, below both the 20-day and 100-day simple moving averages, indicating a bearish trend in the short term.
See More
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- Earnings Performance: Netflix's Q4 earnings report revealed revenue of $12.16 billion, exceeding expectations, yet its Q1 guidance of $12.16 billion fell short of the $12.19 billion consensus, causing shares to drop 5.7% to $82.32 in pre-market trading.
- Earnings Per Share Outlook: The company anticipates Q1 earnings per share of 76 cents, below the consensus estimate of 81 cents, indicating pressure on user growth and profitability, which may undermine investor confidence.
- Other Stock Movements: Erasca Inc announced a proposed $150 million public offering, leading to a 6.2% decline in its pre-market share price to $9.20, highlighting market sensitivity to new stock issuances.
- Market Reaction: Kraft Heinz Co shares fell 5.3% to $22.51 as Berkshire Hathaway filed to sell up to 325 million shares, intensifying market concerns regarding its future performance.
See More
Telix Pharmaceuticals Reports Q4 Revenue Increase to $208 Million
- Revenue Growth: Telix Pharmaceuticals reported Q4 2025 revenue of $208 million, a 46% increase from $142 million in the same period last year, indicating strong performance in the Precision Medicine segment.
- Precision Medicine Contribution: Revenue from the Precision Medicine segment rose to $161 million from $139 million a year ago, reflecting a 15.8% growth and highlighting the ongoing potential of this business line.
- RLS Third-Party Revenue: RLS third-party revenue reached $45 million, compared to zero last year, showcasing Telix's success in expanding partnerships and market share.
- Market Reaction: Despite the revenue increase, Telix's stock fell by 1.03% to $7.68 in pre-market trading on Nasdaq, indicating market caution regarding the company's future performance.
See More
Health Care Stocks Decline as NYSE Health Care Index Eases 0.5%
- Overall Decline in Health Care Stocks: Late Friday afternoon, health care stocks broadly declined, with the NYSE Health Care Index easing 0.5%, reflecting a weakening market confidence in the sector that could impact short-term investor decisions.
- Market Sentiment Fluctuations: The drop in health care stocks may be linked to overall market sentiment fluctuations, as increased uncertainty regarding economic prospects leads to capital outflows from the health sector, affecting industry capital flows.
- Investor Focus Shift: As health care stocks decline, investors may reassess their portfolios, considering reallocating funds to other sectors with greater growth potential, which could impact capital inflows into the health industry.
- Uncertain Future Outlook: The short-term performance of the health care sector may be influenced by policy changes and market dynamics, necessitating investors to closely monitor relevant policies and market trends to make timely investment decisions.
See More
Telix Doses First Patient in BiPASS™ Trial for Prostate Cancer Imaging
- Clinical Trial Launch: Telix has dosed the first patient in the BiPASS™ trial in the U.S., evaluating the use of Illuccix® and Gozellix® for prostate cancer diagnosis, marking a significant advancement in the company's precision medicine efforts.
- Patient Recruitment Plan: The BiPASS™ trial aims to enroll 250 patients across the U.S. and Australia, seeking to enhance diagnostic accuracy by integrating MRI with PSMA-PET imaging, thereby reducing unnecessary biopsies and improving patient experience.
- Significant Market Potential: With over one million prostate biopsies performed annually in the U.S., of which up to 75% are negative, the success of BiPASS™ could drastically decrease biopsy rates and increase the adoption of PSMA-PET imaging, expanding the potential patient population.
- Industry Leadership: Telix CEO Kevin Richardson emphasized that the trial's initiation not only reflects the company's commitment to patient-centricity and clinical innovation but also aims to lower healthcare costs and risks by reducing invasive biopsies, further solidifying its leadership position in the industry.
See More
