Latest Clinical Data News

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.

TrivarX has moved Stabl-Im closer to human testing, with pre-clinical studies underway, investigational product preparation progressing and clinical site selection now open. The indicative plan targets first participant enrolment in Q1 2027, but key technical and ethics steps remain outstanding.

Patrys has dosed the first participants in the Phase 1a trial of RLS-2202, moving its intravenous quetiapine formulation into human clinical evaluation. The next test comes in October, when an independent safety committee will decide whether the program can advance to Cohort 2.

AdAlta has secured a formal US FDA pre-IND meeting for EW-001, moving its mesothelioma CAR-T therapy into a critical regulatory review. The November meeting will test the company’s Australian manufacturing, remaining studies and proposed Phase 1 trial before the more expensive stages of development begin.

Orthocell has recorded the first commercial sales of its Remplir nerve repair product in Thailand, opening a new market estimated at US$84 million. The launch gives the company another distributor-led growth channel, although near-term sales are expected to remain modest.

Telix will acquire ITM in a proposed US$1.65 billion deal that combines a commercial radioisotope supplier with Telix’s precision medicine and therapeutic pipeline. The transaction could give Telix greater supply-chain control and entry into a validated cancer treatment market, but it also brings dilution, integration risk and an unresolved FDA pathway for ITM-11.

Emyria has presented its regulated Australian psychedelic-treatment experience to the US FDA, putting clinical delivery systems rather than drug development at the centre of its US ambitions. The appearance raises the company’s profile, but does not yet disclose regulatory approval, a commercial agreement or a financial commitment.

Dimerix has secured Mexican composition of matter protection for its Phase 2-ready kidney drug DMX-652 until June 2041. The grant expands the asset’s patent estate ahead of planned clinical testing in acute kidney injury, although it brings no new clinical data or regulatory approval.

Emyria has secured a limited in-person speaking position at a US FDA hearing examining how psychedelic medicines could be delivered safely and at scale. The appearance gives the ASX-listed company a regulatory platform, but does not represent FDA approval, funding or a commercial agreement.

Racura Oncology has launched patient enrolment at its first Korean site for the CPACS Phase 1 trial, aiming to accelerate recruitment and validate RC220’s safety and efficacy in a key oncology market.

Nexsen Limited (ASX:NXN) reported a 30% rise in net loss to $6.55 million for FY26, driven by ongoing investment in its Group B Streptococcus rapid diagnostic and Asia-Pacific growth initiatives following its October 2025 IPO.