Latest Therapeutics News

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.

Algorae Pharmaceuticals has secured a $384,466 cash refund from the Australian Taxation Office, reinforcing its financial position to advance AI-driven drug discovery programs.

Cogstate Ltd reports a near doubling in sales contracts for the first half of 2026 but warns of timing-related revenue deferrals that will temper short-term earnings. Despite this, management remains optimistic about medium- and long-term growth prospects.

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.

CLINUVEL Pharmaceuticals is significantly expanding its VALLAURIX RD&I Centre in Singapore with a five-year strategic investment, aiming to become a global leader in advanced peptide drug delivery.

Telix Pharmaceuticals has dosed the first patient in the randomized expansion phase of its pivotal ProstACT Global Phase 3 trial for TLX591, targeting advanced prostate cancer. The trial is expanding globally, with regulatory submissions underway in the US and Europe.

Algorae Pharmaceuticals has independently validated its AI-driven drug combination platform, AlgoraeOS v1, confirming its ability to predict synergistic cancer drug pairs. The company has also launched an upgraded version, AlgoraeOS v2, poised to enhance drug discovery efforts.