Latest Regulatory Approvals News

Wellnex Life Limited has locked in A$9 million in conditional commitments to support its proposed dual listing on the London Stock Exchange’s AIM market, alongside launching a 1:1 entitlement offer for existing shareholders.

Artrya Limited has launched a A$15 million capital raising to fund the development and commercial rollout of its Salix AI-powered coronary artery disease diagnostic platform, targeting the lucrative US healthcare market.

Artrya Limited has secured A$15 million through a two-tranche placement aimed at accelerating regulatory approvals and commercial rollout of its Salix® coronary artery disease diagnostic software in the US.

AVITA Medical reported a strong 30% increase in Q4 2024 commercial revenue and amended its credit agreement with OrbiMed to adjust revenue covenants through 2026. The company is poised for significant growth with new product rollouts and expects profitability by year-end 2025.

AVITA Medical's Q4 2024 earnings reveal strong commercial growth alongside the launch of Cohealyx, a novel collagen-based skin substitute that promises to transform acute wound care.

AVITA Medical reported a robust 30% increase in Q4 2024 commercial revenue alongside key FDA clearances, setting the stage for ambitious growth in 2025.

Cochlear Limited posted a 6% increase in HY25 sales revenue driven by strong implant sales but anticipates FY25 profits at the lower end of guidance due to declining services revenue and rising cloud investments.

Cochlear Limited posted a 5% increase in sales revenue to $1.17 billion for the half year ended December 2024, driven by strong cochlear and acoustic implant growth despite a decline in Services revenue. The company anticipates FY25 underlying net profit at the lower end of guidance amid increased cloud investments and prepares for new product launches.

Cochlear Limited has announced a fully franked dividend of AUD 2.15 per share for the six months ending December 2024, payable in multiple currencies on April 14, 2025.

Cochlear Limited has reported a robust half-year performance with a 7% increase in underlying net profit and an 8% rise in interim dividends, driven by strong sales in cochlear and acoustic implants despite a decline in services revenue.

Recce Pharmaceuticals has temporarily paused trading of its securities, signaling a potentially significant development pending further disclosure.

Neurotech International has inked a development deal with RH Farma to produce a pharmaceutical-grade cannabinoid drug targeting pediatric neurodevelopmental disorders, leveraging advanced European extraction technology.