Latest Biotech News

Nyrada Inc. has released compelling preclinical data showing its drug candidate Xolatryp protects mitochondrial function by reducing calcium overload in brain injury models, bolstering confidence ahead of its Phase IIa trial in acute myocardial infarction.

CSL Limited has partnered with Dutch biotech VarmX to develop VMX-C001, a novel treatment aimed at reversing bleeding in patients on FXa inhibitors, with FDA Fast Track status and a potential 2029 launch.

Spacetalk Ltd has raised $4.05 million through a combination of a conditional placement and convertible notes to accelerate its geographic expansion and app development, alongside appointing a seasoned director to its board.

Alterity Therapeutics has raised A$20 million through a strategic placement to advance its promising ATH434 treatment for Multiple System Atrophy, backed by encouraging Phase 2 trial results. The capital injection strengthens the company’s balance sheet as it prepares for regulatory discussions with the FDA.

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.

Pathkey.AI’s TrialKey platform has demonstrated a 73% alignment with actual biotech trial outcomes, showing an average hypothetical share price gain of 76%, underscoring AI’s growing role in clinical trial prediction and biotech investing.

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.

Osteopore Limited has established OsteoRx, a new special purpose vehicle, with an initial AUD 0.5 million investment to accelerate breakthroughs in cellular regenerative medicine. This strategic move integrates a controlling stake in US-based RxCell Inc, expanding Osteopore’s footprint in the fast-growing stem cell 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.

ASF Group Limited reports a dramatic turnaround to a $25.8 million profit for FY2025, driven by a one-off $32.7 million gain from subsidiary disposals amid a 70% revenue drop.

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.

Patrys Limited reported a 14.9% reduction in net loss for FY2025, driven by lower R&D expenses and tax incentives, while impairing key PAT-DX1 assets and shifting focus to PAT-DX3 development.