Latest Biotechnology News

Argenica Therapeutics’ AI-powered reanalysis of its Phase 2 trial reveals significant efficacy of ARG-007 in severe acute ischemic stroke patients, highlighting improved functional outcomes and reduced brain damage.

Neurizon Therapeutics has secured FDA clearance for its lead drug candidate NUZ-001 to enter the HEALEY ALS Platform Trial, marking a key regulatory milestone and setting the stage for patient enrollment in early 2026.

Tissue Repair Limited has responded to an ASX price query following a sharp rise in its share price and trading volume, denying any undisclosed information and confirming compliance with listing rules.

InhaleRx advances its clinical pipeline with a new oral treatment for resistant depression and plans a strategic rebrand to Nexalis Therapeutics, signaling a broader focus beyond inhaled therapies.

Memphasys Limited has restructured its leadership by eliminating the CEO role to back a direct-selling global commercialisation strategy for its Felix™ System, anticipating imminent CE Mark approval to enter the European IVF market.

Immuron Limited reports topline results from a Uniformed Services University trial of a third-party ETEC product that missed its primary endpoint, reaffirming commitment to its established Travelan dosing ahead of FDA discussions.

InhaleRx Limited has secured $427,500 from an initial tranche of its $1 million capital raise, issuing 17.1 million shares to support its inhaled therapies targeting pain and mental health conditions.

Imugene Limited has received positive feedback from the FDA, aligning key requirements to progress its azer-cel therapy into a pivotal clinical trial, underscoring its growing promise in blood cancer treatment.

Imugene has secured FDA backing to advance its allogeneic CAR T therapy, azer-cel, into a pivotal Phase 3 trial targeting difficult-to-treat diffuse large B-cell lymphoma (DLBCL), including patients relapsed after prior CAR-T treatment.

Chimeric Therapeutics has won FDA Orphan Drug Designation for its CHM CDH17 CAR-T therapy targeting gastric cancer, advancing its clinical development with regulatory incentives and potential market exclusivity.

Neurizon Therapeutics has completed manufacturing three GMP registration batches of its lead ALS drug candidate NUZ-001 ahead of schedule, paving the way for FDA submissions and clinical trial enrollment.

AdAlta Limited has received a $0.78 million Research and Development Tax Incentive refund for FY2025, using part of it to repay a Radium Capital loan and strengthening its cash position as it nears a key licensing milestone.