Latest Regulatory Pathways News

Imagion Biosystems has reached key milestones in its MagSense® HER2 breast cancer imaging program, including starting manufacturing for its Phase 2 trial and launching an AI imaging protocol collaboration with Wayne State University.

PYC Therapeutics has completed dosing in its Phase 1 study of PYC-001 for Autosomal Dominant Optic Atrophy, showing strong safety and early signs of improved vision. The company plans to launch a global Phase 1/2 trial later this year.

Lumos Diagnostics, backed by BARDA, is set to begin a pivotal pediatric clinical study to extend the use of its rapid respiratory infection test, FebriDx, to children aged 2–12 in U.S. CLIA-waived settings, potentially unlocking a $1 billion market.

Island Pharmaceuticals has formally requested a Type C meeting with the US FDA to discuss accelerating approval of its antiviral Galidesivir for Marburg virus using the Animal Rule pathway.

Neurotech International reported a 23% revenue drop and a doubling of its net loss to $10.6 million for FY25, driven by reduced R&D grants and high development costs. Despite financial pressures, the company marked significant clinical and regulatory progress for its NTI164 cannabinoid therapy.

Alterity Therapeutics reported a reduced net loss of A$12.15 million for FY2025, buoyed by positive Phase 2 clinical trial results for its lead drug ATH434 in Multiple System Atrophy and a successful A$40 million capital raising.

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.

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.

Percheron Therapeutics posted a 25% increase in net loss for FY2025 amid termination of its Duchenne Muscular Dystrophy programs. The company pivots strategically to oncology with the in-licensing of HMBD-002, a monoclonal antibody targeting VISTA, aiming to initiate Phase II trials in 2026.

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.

Cleo Diagnostics reported a $4 million loss for FY2025 while making significant strides toward FDA approval of its novel ovarian cancer blood test. The company is progressing clinical trials and scaling manufacturing in preparation for market entry.

Amplia Therapeutics has successfully raised A$2.65 million through its Share Purchase Plan, exceeding expectations and bolstering funding for pivotal clinical trials of its lead drug narmafotinib.