Latest Regulatory Clearance News

Cardiex has kicked off deliveries of its CONNEQT Pulse arterial health monitors in the U.S., reporting strong preorder momentum and a 150% sales increase in December. The company’s strategic operational shifts and pharma partnerships set the stage for sustained growth in 2025.

Classic Minerals Limited has agreed to sell its Kat Gap gold tenements to Bain Global Resources for A$7 million, aiming to reduce debt and refocus on other exploration projects. The deal awaits shareholder approval and regulatory clearances.

Atomo Diagnostics reports a robust Q2 FY25 with $1.2 million revenue driven by HIV self-test sales and a significant $2.44 million government grant for syphilis test development. The company advances its market footprint in Australia and New Zealand while maintaining a strong cash position.

Credit Corp Group Limited has announced a fully franked ordinary dividend of AUD 0.32 per share for the six months ending December 2024, signaling steady shareholder returns.

Blue Star Helium has secured strategic helium and oil and gas assets in Colorado, partnered with Helium One to fund drilling, and raised A$3 million, positioning itself for production growth in 2025.

Black Rock Mining has cleared key regulatory hurdles for POSCO's US$40 million equity injection and secured US$179 million in debt facilities, setting the stage for construction of its Mahenge Graphite Project in Tanzania.

TrivarX has secured positive feedback from the FDA on its pivotal trial design for MEB-001, an AI-driven algorithm targeting major depressive episode screening via sleep study data. The company is advancing site collaborations to launch a large-scale US trial.

OncoSil Medical has achieved a key regulatory milestone with MDR certification from BSI, removing post-market restrictions and streamlining its commercial operations across Europe. This approval also paves the way for renewed efforts to enter the Australian market.

Dropsuite Limited has entered a binding Scheme Implementation Deed with NinjaOne for a $420 million all-cash acquisition at $5.90 per share, representing a significant premium to recent trading prices. The deal, supported unanimously by Dropsuite’s board and largest shareholder, awaits shareholder and regulatory approvals.

Westar Resources reports exceptional gold and silver assay results from its Mindoolah Mining Centre, setting the stage for imminent drilling programs in early 2025. The company maintains a strong cash position while strategically focusing on high-potential projects.

Amcor plc and Berry Global Group, Inc. have entered into a definitive all-stock merger agreement, positioning the combined entity as a global leader in consumer and healthcare packaging with expected annual synergies of $650 million.

Tower Limited has appointed CFO Paul Johnston as interim CEO following Blair Turnbull's resignation, with Deputy CFO Angus Shelton stepping in as interim CFO pending regulatory approval.