Latest Telix Pharmaceuticals (ASX:TLX) News

Telix Pharmaceuticals has lodged a European marketing authorization application for TLX101-Px, a novel PET imaging agent targeting glioma brain cancer, aiming to enhance diagnostic precision and patient access across major European markets.

A small-cap healthcare rally had a clear centre: distribution deals, US regulatory steps, and big cheques. Osteopore, Echo IQ and Anteris led the week, while a handful of names slipped despite solid operational updates.

A takeover offer lit up small caps, while one high-growth software name slid hard despite strong sector news. Resources dominated the winners list, but investors still punished dilution and discounted fundraisings.

Telix Pharmaceuticals has met its upgraded FY 2025 revenue guidance with US$804 million, driven by strong growth in its Precision Medicine segment and the successful US launch of Gozellix. The company also advanced multiple clinical trials and announced a strategic collaboration with Varian to combine radiopharmaceuticals with radiation therapy.

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.

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.

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.

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.

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.

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.

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.

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.