Latest Market Access News

CSL has secured FDA approval for ANDEMBRY®, a pioneering treatment for hereditary angioedema, enabling an immediate US launch with promising clinical results. This milestone marks a significant advance in managing a rare but debilitating condition.

Clara Resources Australia Ltd has had its trading suspension lifted following a capital raising announcement, signaling renewed market activity for the mining company.

Bubs Australia has submitted critical clinical trial data to the US FDA, marking a pivotal step toward permanent approval for its infant formulas in the US market.

Dimerix has reached a key milestone by dosing 200 adult patients in its Phase 3 ACTION3 trial for FSGS, progressing steadily toward full recruitment expected in late 2025.

Control Bionics is on track for its strongest financial year yet, driven by robust US and Australian sales and promising global trials of its NeuroStrip® device.

Kore Potash Plc has had its trading suspension lifted following a key announcement about funding for its Kola Project, signaling renewed investor access and potential project momentum.

Empire Energy Group has launched a $28 million equity raise to finance critical development activities in the Beetaloo Basin, targeting first gas sales from its Carpentaria Pilot Project in 2025. The capital raise, combined with a $65 million financing package, underpins the company’s ambition to commercialize one of Australia’s largest low-CO2 shale gas resources.

Redivium Limited has secured a definitive five-year marketing and offtake agreement with WMC Energy BV, ensuring exclusive global sales of black mass from its UK battery recycling facility.

Wellnex Life Limited has had its trading suspension lifted following its response to ASX queries related to a recent shareholder letter, reopening market access to its shares.

Lumos Diagnostics has secured Medicare reimbursement for its FebriDx test from a sixth Medicare Administrative Contractor, covering over 85% of US Medicare payment regions. This milestone advances the company’s commercialisation efforts in the US healthcare market.

Carnaby Resources has reported promising first drill results from its Trekelano Project in Mt Isa, confirming broad, high-grade copper-gold mineralisation that could significantly enhance the Greater Duchess Copper Gold Project.

OncoSil Medical has secured $8.7 million through a placement and share purchase plan to fund commercialization of its pancreatic cancer treatment device, aiming for positive cash flow by mid-2026. Near-completion clinical trials could soon unlock broader market access.