Latest Fda News

Botanix Pharmaceuticals reports a surge in Sofdra sales driving revenue to $16.5 million, yet the company records a $33.2 million loss amid expanded marketing and operational costs. A $45 million capital raise aims to support growth and supply chain improvements.

PainChek Limited reported a half-year loss of AUD 4.7 million but achieved a major regulatory milestone with FDA clearance for its Adult App, unlocking significant US market opportunities. The company also completed a share consolidation and raised capital to support growth.

Radiopharm Theranostics reported a 44% increase in net loss to $27 million for the half-year ended December 2025, driven by expanded R&D spending. The company bolstered its cash reserves through a $35 million placement while progressing multiple clinical trials across its radiopharmaceutical pipeline.

Lumos Diagnostics reported a 74% increase in its half-year loss to US$4.88 million, despite strong progress with its FebriDx diagnostic test and a landmark US distribution agreement. The company awaits a critical FDA decision that could unlock significant revenue growth.

Anteris Technologies Global Corp. posted a $94.2 million loss for 2025 amid a 29% revenue decline, while progressing its pivotal DurAVR THV clinical trial and securing $320 million in early 2026 financings.

4DMedical Limited’s half-year report reveals rapid commercial traction following FDA clearance of its CT:VQ™ imaging technology, alongside a $150 million institutional placement that bolsters its cash reserves for global expansion.

Mesoblast Limited reported its first commercial sales of FDA-approved Ryoncil, generating $48.7 million in net product sales for the half-year ended December 31, 2025, while reducing its net loss by 16%. The company also secured a $125 million five-year credit facility, restructuring its debt to support ongoing commercialization and development.

Neurotech International reports a dramatic reduction in half-year losses alongside significant clinical and regulatory progress for its lead cannabinoid therapy NTI164. The company also strengthens its cash position through a $4 million placement and a $4.7 million R&D tax refund.

Patrys Limited reported a near doubling of its half-year loss to $3.02 million, driven by restructuring and a strategic pivot including the acquisition of Reliis Pty Ltd. The company is advancing a dual-platform biotech strategy combining a clinical-stage CNS asset with its proprietary antibody platform.

Biotron Limited reported a half-year loss as it completed the acquisition of Sedarex Limited and advanced its Hepatitis B drug candidate BIT-HBV001, backed by a $2.5 million capital raise. The company faces material uncertainty over its going concern status, hinging on securing further funding.

Percheron Therapeutics reports a 64% reduction in half-year losses to $3.1 million, driven by progress in its licensed immuno-oncology drug HMBD-002 and a strategic pivot away from discontinued assets.

Neuren Pharmaceuticals reports a 15% rise in 2025 royalties from its partner Acadia’s DAYBUE sales, with strong 2026 guidance signalling further growth. The launch of a new powder formulation and ongoing regulatory efforts in Europe and Japan add to the momentum.