Latest Regulatory Approval News

Lumos Diagnostics has enrolled 500 patients in its FebriDx CLIA waiver clinical study, unlocking a significant milestone payment from BARDA and moving closer to FDA approval that could open a US$1 billion market.

Mayne Pharma shareholders have overwhelmingly approved the scheme of arrangement for Cosette Pharmaceuticals to acquire the company at $7.40 per share, despite ongoing legal challenges and regulatory approvals still pending.

Bioxyne Limited, through its subsidiary Breathe Life Sciences, has secured a significant supply agreement to enter Germany’s burgeoning medical cannabis market, promising at least A$5.6 million in revenue for FY2026.

Alligator Energy advances regulatory approvals and construction preparations for its Samphire Uranium Project’s Field Recovery Trial, a critical step toward commercial production.

Platinum Asset Management and L1 Capital have advanced their merger talks, completing due diligence and proposing a revised ownership structure favoring L1 Capital shareholders. The deal also outlines a nuanced performance fee arrangement tied to L1’s Long Short funds.

Bastion Minerals Limited has announced a non-renounceable pro-rata rights issue to raise approximately $677,721 at a 50% discount to the last trading price. The funds will support ongoing project evaluation and working capital needs.

Lakes Blue Energy NL has secured $6.5 million through a fully underwritten placement to fund drilling at its Wombat Gas Field in Victoria, aiming to address looming gas supply shortages on Australia's east coast.

PointsBet has released a supplementary scheme booklet revealing an improved $1.20 per share cash offer from MIXI, alongside a postponed shareholder meeting now set for June 25. The deal, backed unanimously by the PointsBet board, faces final court and regulatory approvals.

Lakes Blue Energy has raised $6.5 million through a fully underwritten placement to fund the drilling and testing of its Wombat 5 appraisal well in Victoria, positioning itself to address looming gas shortages on Australia’s east coast.

Diatreme Resources’ Northern Silica Project has been awarded Major Project Status by the Australian Government, marking a pivotal step in advancing critical minerals development in Queensland. This designation streamlines federal approvals and supports the project’s role in the clean energy supply chain.

Recce Pharmaceuticals has locked in a non-dilutive A$30 million debt facility with Avenue Capital Group, extending its cash runway to support pivotal Phase 3 trials and commercialisation of its synthetic anti-infective R327G.

Finder Energy has partnered with global energy giant SLB to fast-track the engineering phase of the Kuda Tasi and Jahal oil fields, potentially bringing forward first oil by a year. This strategic alliance promises cost savings and a streamlined path to project execution.