Latest Regulatory Engagement News

Nexsen Limited has reported significant progress in its rapid diagnostic technologies, including a key FDA pre-submission for its GBS rapid sensor and a solid cash reserve post-IPO to support commercialisation efforts.

Evolution Energy Minerals has ramped up exploration at its Chikundo Copper Project while stabilising its finances and navigating regulatory hurdles in Tanzania. The company is preparing for drilling in 2026 despite a tight cash position.

NT Minerals faces ASX trading suspension but pushes forward with exploration plans at Twin Peaks and Finniss River projects, while considering capital restructuring.

Mesoblast Limited reported a 60% jump in Ryoncil sales to US$35 million for the December quarter, alongside securing a US$125 million credit facility that enhances its financial flexibility and supports ongoing clinical development.

Cynata Therapeutics has completed enrolment in major clinical trials for osteoarthritis and acute graft versus host disease, with pivotal results expected in the second quarter of 2026. The company also strengthened its patent portfolio and secured additional funding to extend its operational runway.

CurveBeam AI reported steady progress in Q2 FY26 with five new device purchase orders, a $4 million milestone payment pending receipt, and key regulatory submissions underway in the US and China.

MyEco Group Ltd has reported record quarterly sales of its MyEcoBag® products, alongside improved gross margins and a significant reduction in operating cash outflows following a strategic operational restructure.

Torque Metals is advancing its Paris Gold Camp project in Western Australia, moving from exploration to development readiness with a 250,000-ounce gold resource and an aggressive drilling program.

Finder Energy Holdings has completed the acquisition of the Petrojarl I FPSO, a critical step that de-risks the KTJ Project and accelerates its path to a Final Investment Decision expected by mid-2026. The company also secured A$25 million in funding and achieved a significant resource upgrade.

Echo IQ has completed clinical validation of its EchoSolv HF heart failure detection software with the Mayo Clinic Platform, achieving outstanding accuracy. The company has now formally submitted its FDA 510(k) clearance application, positioning itself for significant commercial expansion in the US healthcare market.

NH3 Clean Energy has marked significant progress in its WAH2 clean ammonia project, securing major offtake agreements and government facilitation support alongside a $4 million institutional funding round.

Entropy Neurodynamics reports encouraging early clinical results from the first patient treated with TRP-8803, an IV-infused psilocin therapy for Binge Eating Disorder, showing improvements across multiple symptom areas.