Latest Fda News

Botanix Pharmaceuticals posted a sharp revenue increase driven by its new hyperhidrosis treatment Sofdra, yet reported a substantial net loss reflecting heavy investment in commercialisation. The company’s strong cash position underpins its path to profitability.

Singular Health Group reported a $6.38 million loss for FY2025 while securing a pivotal $1.3 million commercial agreement with US-based Provider Network Solutions to deploy its 3DICOM software. The company also completed a major cloud migration of its platform, positioning itself for growth in the US healthcare market.

Chimeric Therapeutics reported a reduced net loss of $10.43 million for FY2025, driven by cost efficiencies and strategic project reprioritisation, while making significant clinical progress in its CAR T-cell and NK cell therapy programs.

Cambium Bio reported a $3.84 million loss for FY25 but secured critical FDA approvals and ethics clearances to initiate Phase 3 trials of Elate Ocular®, supported by a $2.12 million capital raise.

Hydrix Limited narrowed its FY2025 loss to $2.92 million, driven by significant cost reductions and steady revenue from expanding international medtech clients. Despite ongoing challenges in sales cycles and funding, the company remains focused on innovation and strategic investments.

Zelira Therapeutics reported a significantly reduced loss of AUD 3.85 million for FY25, driven by clinical progress and strategic funding for its HOPE® cannabinoid medicines. The company also expanded its patent portfolio and commercial footprint across key markets.

Paradigm Biopharmaceuticals marked FY25 with the launch of its global Phase 3 trial for its osteoarthritis drug iPPS, backed by strong FDA protocol approval and a $41 million funding facility. The company also broadened its pipeline with the acquisition of Pentacoxib™, targeting early-stage OA.

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.

Orthocell Ltd reported a record $9.23 million revenue for FY25, driven by strong sales of its nerve repair and dental products, alongside securing US FDA clearance for its flagship nerve repair device Remplir. The company is poised for accelerated growth as it expands its global commercial footprint.

Echo IQ Limited reported a sharp increase in losses for FY25 despite revenue growth, while securing FDA clearance and expanding its AI-driven cardiology platform across major US networks.

Tissue Repair Ltd reported a 27.3% revenue increase to $3.22 million for FY25, driven by new distribution deals and regulatory progress, while continuing to invest heavily in clinical trials and manufacturing scale-up, resulting in a $4.24 million loss.

Prescient Therapeutics has completed a $3 million share placement, bolstering its clinical development programs for innovative cancer treatments including PTX-100 and novel cell therapies.