Latest Regulatory Reviews News

Alterity Therapeutics has secured FDA Fast Track designation for ATH434, its lead candidate for treating Multiple System Atrophy, potentially speeding up regulatory review and bringing hope to patients with this rare neurodegenerative disorder.

Clime Investment Management has been appointed lead manager for a significant US public offer fund by Sphinx Investments, with initial allocations of $183 million AUD pending SEC approval. The move marks a strategic expansion into the US market, complemented by new wholesale offerings and a partnership with a Dallas-based equities manager.

Alterity Therapeutics reports compelling Phase 2 clinical trial results for ATH434 in Multiple System Atrophy, alongside a significant capital raise strengthening its financial position for upcoming regulatory milestones.

Silver Mines Limited reports steady progress on its flagship Bowdens Silver Project and initiates diamond drilling at the Elsienora Gold Project, while navigating complex regulatory hurdles in New South Wales.

Argenica Therapeutics has completed patient dosing in its Phase 2 trial of ARG-007 for acute ischaemic stroke, with topline data expected in Q3 2025. The company also plans to submit its Investigational New Drug application and Fast Track request to the FDA imminently.

Cleanaway Waste Management reported a 3.7% revenue increase to $1.94 billion for the half-year ending December 2024, while profit after tax remained flat at $74.2 million amid operational challenges including a significant fire at its St Marys facility.

Smart Parking Limited has reported robust H1 FY25 results, underpinned by a strategic acquisition of Peak Parking LP and a fully underwritten $45 million equity raise to fund its US expansion.

The Takeovers Panel has declined to hear Global Lithium Resources’ review application concerning alleged undisclosed shareholder associations ahead of its upcoming AGM, citing procedural timing issues.

Cleo Diagnostics reports steady progress in its U.S. and Australian clinical trials for an ovarian cancer blood test, maintaining a solid cash reserve of A$7.3 million as it prepares for FDA submission.

Po Valley Energy Limited reports a robust December 2024 quarter marked by rising gas production, strong revenue growth, and significant progress in exploration and development across its Italian assets.

Careteq Limited reports solid progress in integrating its Embedded Health Solutions with HMR Referrals, alongside a 14% revenue increase and improved cash flow in Q2 FY25.

NSX Limited reports a $1.6 million cash injection from ISXFEU, completes the ClearPay joint venture sale, and reduces operational costs in its 2Q25 activities report, while facing delays in share issuance approval.