Latest Drug Development News

Neuren Pharmaceuticals has secured a pivotal FDA Type C Meeting to discuss primary efficacy endpoints for its Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, advancing its rare disease drug development.

Actinogen Medical has published a peer-reviewed article confirming the efficacy of a 10 mg daily dose of Xanamem for treating neurological conditions, reinforcing its ongoing clinical trials in Alzheimer's and depression.

Argent BioPharma reports strategic cost-cutting moves including facility closures and delisting from the LSE, while securing German distribution approval and raising significant capital to support its drug pipeline.

Paradigm Biopharmaceuticals has launched a Loyalty and Piggyback Options program aimed at rewarding shareholders and raising up to $111.96 million to support its pivotal Phase III clinical trial.

Emyria Limited reports strong progress in its MDMA and psilocybin-assisted therapy programs alongside a successful $2.525 million capital raise, positioning the company for expanded mental health treatment services.

Vectus Biosystems reports completion of Phase Ib trials for its lead drug VB0004 and a robust cash position bolstered by a significant R&D tax refund, setting the stage for licensing discussions.

Prescient Therapeutics has secured FDA clearance to initiate its Phase 2 PTX-100 trial for relapsed cutaneous T-cell lymphoma, alongside progress in its cell therapy platforms and a solid cash position bolstered by a recent R&D rebate.

Amplia Therapeutics has completed enrolment for its ACCENT Phase 2a trial in advanced pancreatic cancer two months early, reporting encouraging partial response rates and improved patient outcomes.

Race Oncology has advanced its Phase 1 clinical trial for RC220, submitting ethics approvals and bolstering its cash reserves to $18.78 million following a $5.25 million R&D tax incentive.

Argenica Therapeutics has dosed 80% of patients in its Phase 2 stroke trial and gained FDA orphan drug designations for its second candidate, ARG-006. The company reports a cash-positive quarter with $15 million in reserves.

Patrys Limited has halted plans for a Phase 1 trial of PAT-DX1 following disappointing GMP production results, pivoting its development efforts towards PAT-DX3 and exploring new partnerships.

Opyl Limited's Q2 FY25 update reveals robust progress through key partnerships, a new AI Biotech Fund launch, and strengthened financial footing, positioning the company for expanded influence in clinical trial optimisation.