Latest Regulatory Filings News

Echo IQ has initiated a pivotal clinical validation study with the Mayo Clinic Platform to test its EchoSolv HF software, marking the final step before its planned FDA submission in late 2025.

Mesoblast has secured FDA agreement on key requirements for its Biologics License Application for Revascor, targeting ischemic heart failure patients with reduced ejection fraction. The company aims for accelerated approval by year-end 2025.

PointsBet Holdings has dismissed allegations from Betr Entertainment regarding vote exclusion in its recent Scheme of Arrangement meeting, confirming the scheme’s approval and setting the stage for a crucial court hearing.

Cleo Diagnostics has gained approval to access the prestigious PLCO biobank, a move set to strengthen its FDA submission and accelerate development of its ovarian cancer diagnostic tests.

Solis Minerals has voluntarily delisted from the TSX Venture Exchange to concentrate on its primary ASX listing, prompting changes to its ASX waivers and financial reporting calendar.

Rhythm Biosciences has regained NATA accreditation for its geneType laboratory, a key step toward commercialising its ColoSTAT® cancer risk test as an in-house diagnostic.

Findi Limited has appointed DAM Capital and Ambit as lead managers for the IPO of its Indian subsidiary, Transaction Solutions International, targeting a valuation near A$900 million and a 2026 listing.

Brookside Energy has expanded its SWISH Play acreage in Oklahoma's Anadarko Basin by adding a fifth Drilling Spacing Unit, increasing its high-impact drilling inventory by over a quarter. This move strengthens its development pipeline ahead of a planned NYSE listing.

Shift4 Payments, LLC has entered into a definitive scheme implementation agreement to acquire Smartpay Holdings Limited at NZ$1.20 per share, subject to regulatory and shareholder approvals. The transaction outlines a detailed timetable and conditions, including Overseas Investment Office consent and court sanction.

Kinterra Capital has applied to the Takeovers Panel to halt New World Resources’ $10 million placement, arguing it could block rival bids amid an ongoing takeover dispute.

North Stawell Minerals Ltd (ASX – NSM) has opened a $2.1 million non-renounceable entitlement offer to fund key gold exploration projects in Victoria. This follows a $1.5 million placement, together raising $3.6 million to advance drilling and development.

Artrya Limited has submitted a pivotal FDA 510(k) application for its AI-powered Salix® Coronary Plaque module, aiming for clearance in Q3 2025 and a lucrative US commercial launch.