Latest Regulatory Developments News

Telix Pharmaceuticals has secured FDA agreement on a resubmission plan for its glioma imaging agent TLX101-CDx, aiming for a Q4 2025 filing that includes additional efficacy data. The FDA signals likely expedited review, underscoring the unmet medical need.

The Takeovers Panel has approved a key variation to betr Entertainment’s undertaking, removing shareholder approval hurdles for MIXI Australia’s participation in a selective share buy-back tied to its competing bid for PointsBet.

DGL Group Limited has issued a corrected FY25 financial presentation, revealing lower EBITDA and NPAT figures due to operational challenges and restructuring costs. Despite revenue growth, the company faces a modified audit opinion on inventory and outlines strategic cost-cutting and growth investments.

Duxton Farms Ltd has announced a scheme of arrangement to acquire all issued preference shares of Duxton Dried Fruits Pty Ltd, offering a mix of scrip and cash consideration. An independent expert has assessed the transaction as fair and reasonable, endorsing the merger as a strategic step to create a diversified agricultural investment platform.

Astute Metals reports a significant lithium-in-soil anomaly at its Red Mountain Extension project in Nevada, with soil grades up to 1,080ppm and rock chip samples confirming bedrock mineralisation up to 2,690ppm. The company is streamlining its Nevada claims to focus capital on this promising discovery.

333D Limited has responded to ASX queries, clarifying that its Bitcoin Treasury Management Policy approval is not price sensitive, while disclosing a $370,500 Bitcoin acquisition funded partly by R&D tax incentives.

PolyNovo Limited stands to benefit from proposed U.S. Medicare changes that introduce a flat reimbursement rate for outpatient wound care skin substitutes, potentially reshaping the competitive landscape in favour of cost-effective, clinically proven products.

Coast Entertainment Holdings faces a potential regulatory intervention as Queensland's Deputy Premier signals intent to take over assessment of its Dreamworld land development application, citing state economic and environmental interests.

Warriedar Resources has secured a crucial ASX waiver allowing the cancellation of 5 million unlisted options without shareholder approval, smoothing the path for Capricorn Metals’ acquisition scheme.

TerraCom Limited reported a statutory loss of A$33.7 million for FY2025 amid lower coal sales and prices, while progressing its Moorlands Thermal Coal Project in partnership with Wintime Energy Group.

Carbonxt Group Limited reported a 7.1% revenue increase and a significant EBITDA improvement in FY25, while commissioning delays at its Kentucky facility temper near-term optimism.

The Star Entertainment Group reported a statutory net loss of $471.5 million for FY25, impacted by regulatory reforms and remediation costs, while securing a $300 million strategic investment to bolster liquidity.