Latest Regulatory Reviews News

Cleo Diagnostics has received encouraging feedback from the U.S. FDA on its ovarian cancer pre-surgical triage test, reinforcing its clinical trial design and regulatory strategy ahead of a critical 510(k) submission.

The Takeovers Panel has declined to intervene in the Elanor Commercial Property Fund's takeover bid by LDR Assets, following resolution of disclosure concerns.

Elanor Commercial Property Fund has lodged an application with the Takeovers Panel, alleging significant disclosure deficiencies in Lederer’s off-market takeover bid and seeking a replacement bidder’s statement.

Lumos Diagnostics has secured a significant follow-on contract with Aptatek Biosciences to push forward the development of an innovative in-home monitoring device for Phenylketonuria (PKU), a rare genetic disorder. This next phase aims to bring the FDA Breakthrough Device-designated PheCheck™ closer to clinical trials and commercial readiness.

Island Pharmaceuticals has formally requested a Type C meeting with the US FDA to discuss accelerating approval of its antiviral Galidesivir for Marburg virus using the Animal Rule pathway.

Mad Paws Holdings has completed the divestment of its Pet Chemist business and announced the resignation of Executive Director Howard Humphreys, advancing its proposed acquisition by Rover Group.

PEXA Group Limited reported a 16% revenue increase to $393.6 million for FY25, driven by growth across its Australian Exchange, UK International business, and Digital Solutions segments. Despite a statutory net loss of $76.1 million due to impairments and deferred tax derecognition, core EBITDA rose 21% with improved margins.

Manuka Resources’ subsidiary Trans-Tasman Resources has entered a pivotal phase as an expert panel starts assessing its Fast Track application for seabed mining off New Zealand’s coast, aiming to unlock significant economic and mineral export potential.

Heartland Group Holdings Limited reported an underlying NPAT of NZD 46.9 million for FY2025, meeting guidance, while setting ambitious growth and efficiency targets for FY2026.

Prescient Therapeutics reported an 11.1% reduction in net loss for FY2025, progressing its lead candidate PTX-100 into Phase 2a trials with FDA Fast Track and Orphan Drug designations, supported by a recent $9.8 million capital raise.

The Lottery Corporation has reported resilient FY25 results with a dividend increase and strong digital channel growth, despite below-average jackpot outcomes and economic headwinds.

Ainsworth Game Technology reported a 25% revenue increase for the first half of 2025, yet underlying profits slipped due to margin pressures from tariffs and product mix shifts. The launch of the A-Star Raptor dual screen cabinet bolstered Asia Pacific sales, while challenges persist in Latin America and online segments.