Latest Fda News

Mesoblast Limited has reported its FY2025 results, highlighting the FDA approval and US commercial launch of Ryoncil, its first mesenchymal stromal cell therapy, alongside a $102.1 million net loss and $161.6 million in cash reserves.

BlinkLab Limited reported a substantial net loss of $5.7 million for FY2025, driven by intensive R&D and clinical trial activities, while securing $7.66 million in fresh capital to fuel its smartphone-based neurodevelopmental diagnostic platform targeting autism and ADHD.

Cynata Therapeutics reported a $9.39 million net loss for FY2025, slightly improved from the prior year, while progressing multiple clinical trials with key results expected in 2026. The company maintains a solid cash position and funding runway through mid-2026, supported by recent capital raises and an equity subscription agreement.

Argenica Therapeutics reported a 34% revenue increase driven by R&D incentives but saw losses widen by 31% due to intensified clinical trial activity. The company is progressing its ARG-007 Phase 2 stroke trial and engaging with the FDA to lift a clinical hold.

Syntara Limited reported a significantly reduced loss for FY2025, driven by clinical progress and capital raises, while advancing its lead drug amsulostat with FDA Fast Track designation. The company also navigates ongoing payment disputes following the sale of its mannitol respiratory business.

Clarity Pharmaceuticals reported a $64.3 million loss for FY2025 alongside significant clinical progress and a $203.6 million placement to fund its radiopharmaceutical pipeline expansion.

EMVision Medical Devices reported a sharp increase in FY25 losses alongside a 51% revenue drop, yet marked significant progress in clinical trials for its innovative brain scanners and secured $8 million in government grants to fuel commercialisation.

Tetratherix Limited advances its Tetramatrix biomaterial platform with a robust IP portfolio, scalable manufacturing, and strategic partnerships aimed at commercialising across multiple clinical franchises.

dorsaVi appoints Mathew Regan as Group CEO to spearhead commercialisation of next-gen RRAM-enabled AI and robotics technologies, aiming for global expansion.

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.

SomnoMed has delivered a standout FY25 with revenue and EBITDA exceeding market expectations, driven by strong regional growth and operational improvements. The company is now expanding capacity and advancing its innovative Rest Assure device.

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.