Latest Safety News

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.

EBR Systems plans to file a Changes Being Effected PMA supplement in the fourth quarter to make echo-induced pacing risks and their mitigations more prominent on WiSE System labelling. The FDA has aligned with the proposed path, but the filing and final labelling changes are still ahead.

PolyNovo delivered 16.1% revenue growth and a sharp improvement in operating cash flow in FY26, despite a lower statutory profit after a prior-year tax benefit and a fire-related write-off. The ASX-listed wound-care company now expects to lodge its U.S. PMA application for NovoSorb BTM before the end of 2026.

Tivan has secured a 50 km² exploration concession immediately north of its Turiscai project in Timor-Leste, subject to formal regulatory grant. The addition would lift the project to eight licences covering approximately 394 km² ahead of planned maiden drilling in the fourth quarter.

Titomic has secured a US$5.0 million contract to install and commission its TKF 1000 cold spray system at the U.S. Air Force’s Tinker Air Force Base. Delivery is scheduled for the third quarter of 2027, subject to site coordination and approvals.

Entropy Neurodynamics reported that all six patients in Cohort 1 of its Phase 2 BED trial maintained clinically meaningful improvement 12 weeks after two TRP-8803 infusions. Three patients experienced no binge-eating episodes during the 84-day follow-up, although the results come from a small, open-label study without a control group.

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.

Forrestania Resources has signed agreements giving it access to up to 2 million tonnes of third-party ore and a five-year framework for future mining services. Initial supply is expected from stockpiles at MEGA Resources’ Taipan open pit, although volumes, timing and financial returns remain uncommitted.

Paradigm Biopharmaceuticals has drawn the remaining US$2 million available in Tranche 4 of its convertible note facility, adding approximately A$2.8 million to working capital. The funding comes as its fully enrolled Phase 3 knee osteoarthritis trial advances towards interim analysis and top-line results.

Immutep has narrowed eftilagimod alfa’s potential registration pathway to PD-L1-negative head and neck cancer and neoadjuvant soft tissue sarcoma after identifying product differences between manufacturing scales used in earlier studies and TACTI-004. A new 200 L manufacturing run is planned, but replacement trials are not targeted to start until the second half of 2027 and remain subject to regulatory, funding and partnering decisions.

WasteCo is asking eligible New Zealand shareholders for up to NZ$750,000 in fresh equity as it tackles NZ$40.1 million of debt, a FY2026 loss and an aggressive operational reset. The non-underwritten plan follows a separate placement and is priced at NZ$0.007 per share.

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.