Latest Therapeutics News

Opthea Limited has announced a strategic pivot to develop OPT-302 for Lymphangioleiomyomatosis (LAM), a rare lung disease affecting women, aiming for ASX reinstatement in 2026. The company leverages strong intellectual property and cash reserves to pursue orphan drug designation and clinical development.

Entropy Neurodynamics has successfully completed dosing the first patient in its TRP-8803 clinical trial for Binge Eating Disorder, marking a key milestone with controlled psychedelic infusion and safety clearance. Top-line results are expected in early 2026.

Radiopharm Theranostics reports promising interim Phase 2b results for RAD 101, achieving 92% concordance with MRI in detecting brain metastases, paving the way for a pivotal study in 2026.

Prescient Therapeutics has secured European authorization to initiate a Phase 2a clinical trial of its novel cancer drug PTX-100 for relapsed/refractory Cutaneous T-cell Lymphoma, enabling trial site activation in Italy.

Cynata Therapeutics has finalised patient enrolment in its pivotal Phase 2 trial of CYP-001 for acute graft versus host disease, setting the stage for critical data due mid-2026.

Dimerix has successfully completed recruitment and dosing of 286 adult patients in its Phase 3 ACTION3 trial evaluating DMX-200 for focal segmental glomerulosclerosis (FSGS), advancing toward regulatory discussions with the FDA.

Imricor Medical Systems has secured Institutional Review Board approval for the University of Virginia Health to join its VISABL-AFL clinical trial, marking a key expansion in the US. Procedures are set to begin early next year, supporting Imricor’s progress toward FDA approval and commercialisation.

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.

Bioxyne Limited has secured a pioneering manufacturing and supply agreement to enter the emerging medicinal cannabis markets of Costa Rica and Panama, positioning itself as a first mover with promising revenue potential.

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.

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.

LTR Pharma has received regulatory clearance from the Therapeutic Goods Administration to commence its Phase II clinical trial of SPONTAN, focusing on men aged 65 and over. Patient recruitment is set to begin early next year, aiming to address a key gap in erectile dysfunction treatment.