Latest Regulatory News

Imugene Limited has received positive feedback from the FDA, aligning key requirements to progress its azer-cel therapy into a pivotal clinical trial, underscoring its growing promise in blood cancer treatment.

Ainsworth Game Technology forecasts a slight decline in full-year profit driven by weaker North American sales in the second half, despite revenue growth in Asia-Pacific and Latin America.

Sparc Hydrogen has appointed Alana Barlow as its inaugural CEO, marking a strategic move to accelerate commercialisation of its innovative photocatalytic water splitting technology for green hydrogen.

DMC Mining's progress in Guinea is stalled as the government halts new exploration licences until after the December presidential election, prompting a 12-month extension on acquisition terms.

Imugene has secured FDA backing to advance its allogeneic CAR T therapy, azer-cel, into a pivotal Phase 3 trial targeting difficult-to-treat diffuse large B-cell lymphoma (DLBCL), including patients relapsed after prior CAR-T treatment.

Talius Group appoints seasoned executive Pat Howard as CEO, with founder Graham Russell shifting to a strategic growth role, signalling a new phase of expansion and innovation.

Novatti Group’s investment in AUDC Pty Ltd, issuer of the AUDD stablecoin, has nearly doubled in value following a $5 million Pre-Series A funding round led by a major global institutional investor.

National Storage REIT has entered a definitive agreement to be acquired by a Brookfield and GIC-led consortium for $2.86 per security, valuing the company at $4 billion. The Board unanimously recommends the scheme, pending shareholder and regulatory approvals.

Chalice Mining’s Pre-Feasibility Study confirms the Gonneville Project as a globally significant palladium-nickel-copper mine in Western Australia, boasting robust returns and a rapid payback period.

Critical Resources Limited has partnered with Canada's Pathway Group to accelerate permitting, funding, and stakeholder engagement for its Mavis Lake Lithium Project, aiming to cement its role in North America's lithium supply chain.

Chimeric Therapeutics has won FDA Orphan Drug Designation for its CHM CDH17 CAR-T therapy targeting gastric cancer, advancing its clinical development with regulatory incentives and potential market exclusivity.

Telix Pharmaceuticals has dosed the first patient in the randomized expansion phase of its pivotal ProstACT Global Phase 3 trial for TLX591, targeting advanced prostate cancer. The trial is expanding globally, with regulatory submissions underway in the US and Europe.