Latest Telix Pharmaceuticals (ASX:TLX) News

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Telix Scores Regulatory Nod to Bring Illuccix Prostate Imaging to China

Telix Pharmaceuticals has achieved a key milestone with China’s NMPA accepting its New Drug Application for Illuccix, a prostate cancer imaging agent backed by strong Phase 3 data. This paves the way for Telix to enter a rapidly growing Chinese market alongside its global approvals.
Ada Torres
20 Jan 2026

Telix Advances With Strong Illuccix Data and FDA Resubmission Progress

Telix Pharmaceuticals reports positive Phase 3 results for its prostate cancer imaging agent Illuccix in China, paving the way for a near-term regulatory submission. Meanwhile, the company advances FDA resubmissions for its glioma and kidney cancer imaging candidates.
Ada Torres
22 Dec 2025

Telix Advances ProstACT Phase 3 Prostate Cancer Trial to Part 2 with Global Approvals

Telix Pharmaceuticals confirms completion of Part 1 enrolment in its ProstACT Phase 3 trial for prostate cancer, with safety data supporting progression to Part 2 and regulatory approvals secured across multiple countries.
Ada Torres
17 Dec 2025

Telix Advances ProstACT Phase 3 Trial with First Patient Dosed in Global Expansion

Telix Pharmaceuticals has dosed the first patient in the randomized expansion phase of its pivotal ProstACT Global Phase 3 trial for TLX591, targeting advanced prostate cancer. The trial is expanding globally, with regulatory submissions underway in the US and Europe.
Ada Torres
8 Dec 2025

Telix Surges with US$206M Q3 Revenue and Boosted FY 2025 Outlook

Telix Pharmaceuticals reports a robust 53% revenue jump in Q3 2025 and raises its full-year guidance, underpinned by key reimbursement wins and expanding clinical programs.
Ada Torres
14 Oct 2025

CMS Boosts Telix’s Gozellix with Key US Reimbursement Win

Telix Pharmaceuticals secures Transitional Pass-Through payment status for its next-generation prostate cancer imaging agent Gozellix, paving the way for broader US patient access and streamlined provider reimbursement.
Ada Torres
23 Sept 2025

Telix and FDA Align on Resubmission for TLX101-CDx with Expedited Review Expected

Telix Pharmaceuticals has secured FDA agreement on a resubmission plan for its glioma imaging agent TLX101-CDx, aiming for a Q4 2025 filing that includes additional efficacy data. The FDA signals likely expedited review, underscoring the unmet medical need.
Ada Torres
9 Sept 2025

Telix Faces FDA Setback on TLX250-CDx but Eyes Swift Resolution

Telix Pharmaceuticals has received a Complete Response Letter from the FDA for its TLX250-CDx diagnostic agent, citing manufacturing concerns. The company plans immediate remediation and maintains its 2025 revenue guidance.
Ada Torres
28 Aug 2025

Telix Pharmaceuticals Accelerates Growth with 63% Revenue Surge and Pipeline Advances

Telix Pharmaceuticals reported a robust 63% year-over-year revenue increase in H1 2025, driven by strong sales of its precision medicine products and strategic acquisitions. The company is advancing multiple late-stage clinical trials and expanding its global manufacturing footprint.
Ada Torres
21 Aug 2025

Telix Powers Ahead with 63% Revenue Surge and Pipeline Milestones

Telix Pharmaceuticals reported a robust 63% revenue increase in H1 2025, driven by commercial growth and strategic investments, while advancing key clinical trials and maintaining full-year guidance.
Ada Torres
21 Aug 2025

Telix Pharmaceuticals Posts 63% Revenue Surge Amid Strategic Expansion and SEC Inquiry

Telix Pharmaceuticals reported a robust 63% increase in revenue to $390.4 million for the first half of 2025, driven by strong Illuccix sales and the acquisition of RLS Radiopharmacies. Despite this growth, the company recorded a net loss of $2.3 million, reflecting increased investments and finance costs.
Ada Torres
21 Aug 2025

Telix Shifts to USD Reporting, Signals Growth with Expanded US Operations

Telix Pharmaceuticals has recast its historical financials from AUD to USD to better reflect its US-centric revenue streams and reports increased operating expenditure tied to recent acquisitions and growth initiatives.
Ada Torres
5 Aug 2025