Latest Biopharmaceuticals News

Telix Pharmaceuticals has announced FDA acceptance of its resubmitted NDA for TLX101-Px (Pixclara®), a PET imaging agent for glioma, setting a PDUFA goal date of September 11, 2026. The agent addresses a significant unmet need in distinguishing recurrent glioma from treatment effects.

Radiopharm Theranostics has received a positive recommendation to escalate the dose of its 177Lu-RAD202 radiotherapeutic in a Phase 1 trial targeting HER2-positive advanced solid tumors, maintaining its timeline to complete dose escalation by year-end 2026.

Radiopharm Theranostics has secured a clinical supply agreement with Siemens Healthineers to manufacture and distribute RAD101, advancing its Phase 3 trial in the U.S. Interim Phase 2b data showed 90% concordance with MRI in detecting brain metastases.

Telix Pharmaceuticals posted an 11% increase in Q1 2026 revenue to US$230 million, reaffirmed full-year guidance, and reported progress in multiple clinical trials including its lead prostate cancer therapy TLX591-Tx.

Radiopharm Theranostics has initiated dosing in its Phase 1 clinical trial of RAD 402, a novel radiolabelled antibody targeting KLK3 in advanced prostate cancer. Early data from the trial’s initial dose levels are expected in the second half of 2026.

Radiopharm Theranostics reports promising second interim Phase 2b results for RAD 101, showing 90% concordance with MRI in detecting brain metastases and encouraging sensitivity and specificity trends.

Neurotech International has opened the first clinical site for its pivotal Phase 3 trial of NTI164, targeting core symptoms of Autism Spectrum Disorder in children. This milestone marks a key step toward potential regulatory approval and commercialisation.

Racura Oncology has secured governance approval to launch its Phase 1 HARNESS-1 trial, testing RC220 alongside osimertinib in EGFR-mutated non-small cell lung cancer patients. This milestone sets the stage for a potentially pivotal new approach to overcoming resistance in lung cancer treatment.

Dimerix Limited is set to conduct a blinded statistical review of its pivotal Phase 3 ACTION3 study in March 2026, aiming to confirm the trial remains powered to demonstrate the primary endpoint of proteinuria reduction in FSGS patients.

Telix Pharmaceuticals has resubmitted its New Drug Application to the FDA for TLX101-Px (Pixclara®), aiming to advance a novel PET imaging agent for glioma diagnosis. The resubmission addresses prior regulatory concerns with additional data, reinforcing hopes for expedited approval.

Dimerix Limited has completed dosing of the last adult patient in its ACTION3 Phase 3 trial for DMX-200, exceeding its recruitment target and setting the stage for key regulatory milestones.

Telix Pharmaceuticals has announced that Part 1 of its ProstACT Phase 3 trial for TLX591-Tx met its primary safety and dosimetry objectives, with no new safety concerns. The study’s success supports ongoing global enrolment in Part 2 and regulatory engagement in the US.