Latest Safety News

Prescient Therapeutics has raised approximately $6 million through its Share Purchase Plan and a shortfall placement, giving PTX-100 additional funding beyond a key clinical review in December. The next test is whether early results support a move into Phase 2b development.

Paradigm Biopharmaceuticals has secured a voluntary suspension of its ASX securities while it prepares to release interim analysis results from its PARA_OA_012 Phase 3 trial. The announcement gives no indication whether the clinical readout is favourable or unfavourable, with trading potentially resuming on 28 September subject to ASX approval.

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.

Actinogen Medical has completed the final patient visit in its 247-participant XanaMIA Alzheimer’s disease trial, keeping topline results on track for November 2026. The milestone closes patient participation in the pivotal study, but provides no indication yet of whether Xanamem improved outcomes.

Dimerix has drawn A$17 million from a non-dilutive facility, giving the biotech funding it says is sufficient to complete the ACTION3 Phase 3 trial of DMX-200 and continue developing DMX-652. A further A$17 million remains available, although repayment depends partly on future licensing income, milestones or capital-market access.

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.

Elementos has materially strengthened its balance sheet while moving its Spanish Oropesa tin project closer to permitting, financing and a final investment decision. The annual report also highlights a doubling of Cleveland’s inferred tungsten resource, but both projects still require substantial capital and further approvals.

Nyrada has secured AU$12.0 million from institutional and sophisticated investors, with a further AU$2.0 million shareholder purchase plan planned, giving the biotech funding to advance its Xolatryp clinical programs. The raise also carries substantial dilution and an unusually large proposed director subscription worth AU$5.125 million, subject to shareholder approval.

Neurotech International has dosed the first patient in its pivotal Phase 3 Beyond Harmony study of NTI164, moving the autism therapy into its most consequential clinical test yet. The trial plans to enrol up to 200 children across six Australian sites, but no Phase 3 efficacy data are available at this stage.

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.

Epiminder has enrolled the 75th patient in its DETECT study, meeting its September target as the US site network expands to 21 centres. The company expects to reach 100 enrolments in November and remains focused on completing the 210-patient study by the end of the first half of calendar 2027.

Patrys has formed an international Clinical Advisory Committee to help shape the next stages of RLS-2202, its injectable quetiapine candidate for delirium in acute-care settings. The appointments add recognised expertise in delirium research, intensive care and trial design, but do not yet provide clinical efficacy or regulatory evidence.