Latest Commercialization News

SomnoMed delivered a strong FY25 performance with revenue climbing 22% to $111.5 million and EBITDA turning positive at $9.2 million, boosted by operational improvements and FDA clearance of its Rest Assure device. The company projects further growth in FY26 with expanded manufacturing and ongoing innovation.

Control Bionics Limited has announced a $2.06 million non-renounceable rights issue to fund the commercial expansion of its NeuroStrip device and bolster NeuroNode operations. The capital raise is underwritten to approximately $1.15 million by major shareholders and strategic partners.

Invion Limited has affirmed its compliance with ASX disclosure rules following the US FDA’s granting of Orphan Drug Designation for its anal cancer treatment candidate INV043. The company detailed the timing and verification process behind its announcement.

Zoono Group Limited reported a 19.1% revenue increase to NZ$1.25 million for FY2025, alongside a significantly reduced net loss. The company is pivoting towards B2B markets, focusing on antimicrobial and shelf-life extension technologies, supported by a recent AUD 1.78 million capital raise.

Tetratherix Limited reports its first financial results as a listed company, revealing a $9.4 million statutory loss driven by R&D and listing costs, alongside a robust $29.3 million cash position post-IPO. The company highlights key operational milestones and outlines strategic plans to accelerate commercialisation across its innovative biomaterial platform.

Lynas Rare Earths reported FY25 results featuring record NdPr output and the first commercial heavy rare earths production outside China, alongside a $750 million equity raise to fund its ambitious Towards 2030 growth strategy.

Dimerix Limited reported a 22% reduction in its FY2025 loss to $13.25 million, driven by strong licensing revenues and advancing its pivotal Phase 3 clinical trial for DMX-200. The company secured new global partnerships valued at up to AU$1.4 billion, bolstering its cash reserves and commercial prospects.

Lynas Rare Earths reports FY25 revenue growth amid profit decline, completes major capital projects, and launches a $750 million equity raise to fund its expansive Towards 2030 strategy.

Lynas Rare Earths reported a 20% revenue increase in FY25 driven by higher NdPr sales, yet net profit fell sharply amid ramp-up costs and market challenges. The company completed key growth projects and unveiled its Towards 2030 strategy focused on downstream expansion.

Telix Pharmaceuticals has received a Complete Response Letter from the FDA for its TLX250-CDx diagnostic agent, citing manufacturing concerns. The company plans immediate remediation and maintains its 2025 revenue guidance.

Micro-X reported FY25 revenue of $13.1 million, underpinned by significant US government contracts and pioneering 3D head CT imaging technology, setting the stage for clinical trials and commercial expansion.

Tetratherix Limited reported a $9.4 million statutory loss for FY25 amid significant R&D and operational investments, successfully listing on the ASX and progressing multiple clinical and manufacturing initiatives.