Latest Clinical Trials News

SomnoMed Limited reported a record FY25 with $111.5 million revenue and a return to positive EBITDA, marking a milestone of over one million patients treated globally. The company secured FDA clearance for its Rest Assure® compliance tracking device and provided optimistic guidance for FY26.

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.

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.

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.

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.

Emyria Limited reports a reduced net loss of $3.14 million for FY2025, driven by strategic expansion in psychedelic-assisted mental health treatments and key partnerships including insurer Medibank. The company advances clinical services while continuing R&D on proprietary medicines.

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.

Micro-X Limited reported a $13.9 million loss for FY2025 as it pivots towards medical imaging, securing a landmark supply agreement with a major US healthcare provider for its Rover Plus mobile X-ray system.

Biotron Limited reported a significantly reduced net loss of $318,572 for FY2025, bolstered by a $1.27 million capital raise and a $1.81 million R&D tax rebate, as it advances clinical and preclinical antiviral programs.

Cyclopharm Limited reports a 26% revenue jump to $15.42 million in H1 2025, driven by rapid U.S. expansion and extended patent protections for its Technegas® lung imaging technology.

Imagion Biosystems reported a $1.66 million loss for the half-year ending June 2025 while progressing its MagSense® HER2 Imaging Agent towards a Phase 2 FDA trial and securing $3.5 million in new funding.