Welcome to our dedicated page for Telix Pharmaceut SEC filings (Ticker: TLPPF), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Telix Pharmaceuticals Limited (TLPPF) SEC filings page on Stock Titan provides access to the company’s U.S. regulatory submissions, with AI-powered tools to help interpret them. Telix Pharmaceuticals Limited is a foreign private issuer that furnishes current reports on Form 6-K and indicates that it files annual reports on Form 20-F. These filings connect U.S. investors to announcements first made to the Australian Securities Exchange.
Each Form 6-K cover page identifies an attached announcement or press release, typically labeled as Exhibit 99.1. Examples include “Telix JP Morgan Healthcare Conference 2026 Presentation,” “Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions,” “ProstACT Global Study Status,” “1st Patient Dosed in ProstACT Global Randomized Tx Expansion,” “Telix Reports US$206M Revenue, FY 2025 Guidance Upgraded,” and “CMS Grants Transitional Pass-Through Status for Gozellix.” The detailed content is contained in the exhibits, while the Form 6-K itself confirms the nature and title of each disclosure.
On this page, you can review Telix’s Form 6-K submissions as they appear in the SEC’s EDGAR system, with real-time updates as new filings are furnished. AI-generated summaries highlight the key points of lengthy documents, helping you quickly understand the focus of each announcement. You can also use this page to locate Telix Pharmaceuticals Limited’s annual Form 20-F filings when available, giving you a structured way to examine both periodic and event-driven disclosures associated with the TLPPF symbol.
Telix Pharmaceuticals Limited has resubmitted a New Drug Application to the U.S. FDA for TLX101-Px (Pixclara), a PET imaging agent designed to help distinguish recurrent or progressive glioma from treatment-related brain changes in adult and pediatric patients.
The resubmission includes additional data and statistical analyses requested in a prior Complete Response Letter, alongside the original primary data set. TLX101-Px has Orphan Drug and Fast Track designations, reflecting its potential to address a significant unmet need, as there is currently no FDA-approved targeted amino acid PET agent for adult and pediatric brain cancer imaging in the U.S.
Telix Pharmaceuticals reported that Part 1 of its ProstACT Global Phase 3 study for TLX591-Tx in metastatic castration resistant prostate cancer achieved its primary objectives, showing an acceptable safety and tolerability profile with no new safety signals in 36 treated patients.
Patients received two doses of TLX591-Tx 14 days apart alongside standard therapies (enzalutamide, abiraterone or docetaxel) across three cohorts of 11, 11 and 14 patients. Most non-hematologic side effects were low grade, hematologic events were transient and manageable, and organ radiation exposure was below established safety limits. The study has already advanced into Part 2 outside the U.S., and Telix plans to present Part 1 data to the FDA to seek an IND amendment to expand Part 2 in the U.S.
Telix Pharmaceuticals files its annual report detailing a growing commercial radiopharmaceutical business alongside continued losses and regulatory risk. The company reported a loss after tax of $7.1 million and net operating cash outflow of $17.3 million for the year, with an accumulated deficit of $154.5 million. As of December 31, 2025, Telix held $141.9 million in cash and cash equivalents and had $426.1 million of 2.375% unsecured convertible bonds due 2029, plus $10.3 million of other debt, against 338,777,049 ordinary shares outstanding.
The business now relies heavily on two approved imaging products, Illuccix and Gozellix, which are commercial in multiple jurisdictions. However, key pipeline programs have faced regulatory setbacks: TLX250‑Px and TLX101‑Px each received FDA Complete Response Letters requiring additional chemistry, manufacturing, controls and clinical evidence, and both are being prepared for resubmission. The Phase 3 ProstACT Global trial of therapeutic candidate TLX591‑Tx is underway. Management highlights the need for potential additional capital, execution of its acquisition integrations, and careful control of leverage while advancing an expanding clinical and commercial footprint.
Telix Pharmaceuticals Limited reports strong 2025 growth but lower profitability. Revenue rose to US$803.8 million, a 56% increase from 2024, driven by its Precision Medicine business and the RLS Radiopharmacies acquisition. Operating profit was US$29.8 million, yet higher R&D, manufacturing scale-up, and finance costs led to a net loss after tax of US$7.1 million, versus a US$33.7 million profit a year earlier.
Adjusted EBITDA declined to US$39.5 million as Telix increased R&D spending to US$171.2 million and expanded manufacturing infrastructure in the U.S., Europe, Japan, and Australia. Cash and equivalents fell to US$141.9 million from US$440.0 million, reflecting acquisition payments and capital investment, while the company continued advancing late-stage therapeutic trials and global product launches.
Telix Pharmaceuticals Limited submitted a European Marketing Authorization Application for its product candidate TLX101-Px, which is designed for brain cancer imaging. The company reported this regulatory milestone to U.S. investors by furnishing on Form 6-K the related announcement it filed with the Australian Securities Exchange.
Telix Pharmaceuticals Limited has announced a leadership change at the Board level. Ms. Tiffany Olson has resigned as Non-Executive Director and Board Chair, effective 3 February 2026.
Long-standing independent Non-Executive Director Dr. Mark Nelson has been appointed Interim Chair. The Board states it is in advanced stages of appointing new Non-Executive Directors and is committed to naming a new Independent Chair as soon as feasible. Dr. Nelson emphasized appreciation for Olson’s service and reiterated that Telix has a strong commercial business and pipeline, and that this governance change is not expected to affect delivery of near-term milestones or the company’s long-term growth strategy.
Telix Pharmaceuticals Limited filed a Form 6-K highlighting two key updates first released on the Australian Securities Exchange. The company reports that the Chinese National Medical Products Administration has accepted a New Drug Application for Illucix, marking an important regulatory step for this product in China. Telix also states that it achieved its FY 2025 guidance with US$804 million (A$1.2 billion) in revenue and is accelerating growth with the launch of Gozellix. Together, these disclosures point to strong recent commercial performance and progress in expanding the company’s product portfolio and geographic reach.
Telix Pharmaceuticals Limited submitted a foreign issuer report to the U.S. securities regulator to furnish investors with a copy of a presentation given at the JP Morgan Healthcare Conference 2026. The company states that it filed an announcement with the Australian Securities Exchange on January 12, 2026 titled “Telix JP Morgan Healthcare Conference 2026 Presentation,” and has attached this as an exhibit for U.S. investors. This filing is primarily administrative, making the same information available in the U.S. market that was released in Australia.
Telix Pharmaceuticals Limited submitted a Form 6-K to share with U.S. investors an announcement it filed with the Australian Securities Exchange. The attached announcement, titled “Precision Medicine Portfolio Update: Illuccix China Phase 3 Study, TLX101-CDx and TLX250-CDx FDA Resubmissions,” outlines developments in Telix’s precision medicine portfolio. This report mainly serves to furnish that ASX announcement as Exhibit 99.1 for the U.S. market.