Latest Theranostics News

Telix’s Pixclara has become the first FDA-approved FET-PET imaging drug for glioma, opening a new US diagnostic pathway for adults and children. The approval is commercially significant, but pricing, reimbursement and launch timing remain undisclosed.

Neurizon has appointed Dr Chris Bremer as chief executive as its NUZ-001 ALS program moves towards topline Phase 2/3 results expected in late Q2 2027. The incoming CEO brings more than 20 years of pharmaceutical and biotechnology experience, including over US$1 billion in licensing transactions.

Telix Pharmaceuticals has completed enrollment in its pivotal Phase 3 BiPASS trial for prostate cancer imaging and aligned with the FDA on a pathway that could expand U.S. patient access and reimbursement for its 68Ga-PSMA-PET agents.

Clarity Pharmaceuticals reported a 67% increase in net loss to $107.2 million for FY26, driven by higher R&D spending, while advancing multiple Phase III trials and expanding manufacturing capacity ahead of commercialisation.

Radiopharm Theranostics has dosed the first patient in the second cohort of its Phase 1/2a trial for RV-01, a radiopharmaceutical targeting B7-H3 expressing solid tumors, marking a key dose escalation milestone.

Radiopharm Theranostics is gearing up for a pivotal Phase 3 trial of its brain metastases imaging agent RAD101, following strong Phase 2b results and an upcoming FDA meeting to finalise trial design.

Clarity Pharmaceuticals bolsters its commercial readiness with a $178.3 million cash reserve and a key US manufacturing agreement, while clinical trials for its prostate cancer imaging and therapeutic agents progress with promising data.

Radiopharm Theranostics (ASX: RAD) has requested an immediate voluntary suspension of its shares pending a material capital raising announcement expected before markets open on 27 July 2026.

Radiopharm Theranostics reported robust Phase 2b results for RAD101 in brain metastases imaging, hitting 93% concordance with MRI and setting the stage for a U.S. Phase 3 trial. Meanwhile, its Phase 1 trial of RAD204 showed durable partial responses and good tolerability in advanced solid tumors.

Telix Pharmaceuticals reported a 21% year-on-year revenue jump to US$247 million in Q2 2026, buoyed by strong Precision Medicine sales and a new Regeneron partnership. The company also secured FDA alignment on a pivotal prostate cancer trial and expanded its manufacturing footprint.

Starpharma Holdings is raising approximately $32 million through a fully underwritten 1-for-7.5 renounceable entitlement offer priced at $0.57 per share, discounting the stock by 25%. Proceeds will fund the DEP HER2-Lu Phase 1 trial and expand its dendrimer-based oncology pipeline.

Starpharma launches a fully underwritten $32 million entitlement offer to fund the Phase 1 trial of its DEP® HER2-Lutetium radiopharmaceutical and accelerate its targeted oncology asset development.