Latest Clinical Trials News

Radiopharm says the FDA has provided a clear framework for the pivotal development of RAD101, its investigational brain metastases imaging agent. The company is preparing for Phase 3 while awaiting formal meeting minutes that could still refine the trial design and regulatory requirements.

AdAlta and Shanghai Cell Therapy Group have approved the FDA briefing pack and manufacturing transfer plan for EW-001, bringing the mesothelioma CAR-T therapy closer to an Australian Phase 1 trial. The FDA meeting is scheduled for November, while two Chinese patients remain under follow-up, including a second complete responder.

CSL has secured an exclusive agreement to co-develop and co-promote Alentis Therapeutics’ investigational drug lixudebart, committing US$355 million upfront and funding a multi-trial development programme. The antibody remains unapproved, with its commercial potential dependent on results from ongoing and planned clinical studies.

LTR Pharma has completed the final Phase II pharmacokinetic report for SPONTAN, confirming a median 10-minute time to peak concentration against 60 minutes for an oral vardenafil tablet. The result completes the FDA-aligned dataset ahead of planned US submission work, although efficacy in erectile dysfunction patients remains to be tested.

Radiopharm Theranostics reported a A$56.3 million comprehensive loss for fiscal 2026, with operating cash outflows rising to A$52.8 million and cash falling to A$4.1 million. The company says further funding is required, while auditors flag a material uncertainty over its ability to continue as a going concern.

Clarity Pharmaceuticals is approaching pivotal Phase III readouts for its prostate cancer imaging agent, backed by AUD178.3 million in liquid assets. The radiopharmaceutical developer remains deeply loss-making, but expanded manufacturing capacity and early clinical signals are pulling its commercial ambitions into sharper focus.

Imagion Biosystems has secured central ethics approval for its US Phase 1b/2 trial of the MagSense HER2 imaging agent, removing a key requirement before recruitment can begin. Site activation is now underway, but no patient has yet been enrolled and the announcement provides no clinical data.

Paradigm Biopharmaceuticals has entered voluntary administration after its pivotal Phase 3 trial produced an interim efficacy result below the threshold required for continuation. The company’s securities will remain suspended while administrators assess its viability, liabilities and possible restructuring options.

Vectus Biosystems has secured a pre-IND Type B meeting with the FDA for its lead IPF drug candidate VB0004. The regulator’s written feedback, expected by mid-November, should clarify the next US development steps but does not yet authorise clinical trials.

Telix has secured FDA Fast Track designation for BiPASS, its Phase 3 program testing 68Ga-PSMA-PET alongside MRI before prostate biopsy. The milestone may support closer FDA engagement and faster review of a planned NDA, but the indication remains investigational and no BiPASS results were disclosed.

TrivarX has made Stabl-Im its central development bet, but the ASX-listed health technology company also reported an $8.76 million FY2026 loss and an auditor-flagged material uncertainty over its ability to continue without further funding. The planned Phase 1 study remains subject to regulatory, ethics and operational clearances.

Argent BioPharma has secured exclusive commercialisation rights to selected Tollovir, Tollovid and NutraVir antiviral products in a worldwide deal excluding China. The agreement adds a new commercial pillar alongside CimetrA®, but does not itself grant pharmaceutical development rights or establish clinical efficacy.