Latest Clinical Data News

Neuren Pharmaceuticals has received official FDA minutes confirming the primary endpoints for its pivotal Phase 3 trial of NNZ-2591 targeting Phelan-McDermid syndrome, reinforcing the positive signals from earlier studies.

Orthocell has secured regulatory approval to sell its nerve repair product Remplir™ in Hong Kong well ahead of schedule, expanding its footprint across key global markets. This milestone complements recent clearances in the US, Canada, and Asia, positioning the company for significant growth in a multi-billion-dollar market.

Radiopharm Theranostics has secured Data Safety and Monitoring Committee approval to escalate dosing in its Phase 1 trial of 177Lu-RAD204, expanding patient cohorts across multiple cancer types.

AVITA Medical reported a robust 67% increase in first quarter 2025 revenue, driven by new product launches and a strategic commercial overhaul, while reaffirming its full-year growth and profitability targets.

Alterity Therapeutics is set to present compelling Phase 2 clinical trial results for ATH434 at the 2025 International Multiple System Atrophy Congress, highlighting slowed disease progression and biomarker engagement in MSA patients.

Dimerix has received a US$30 million upfront payment from Amicus Therapeutics for exclusive US rights to DMX-200, a promising kidney disease therapy. The deal positions Dimerix for up to US$560 million in further milestones plus royalties, underpinning its global licensing strategy.

Alterity Therapeutics has secured FDA Fast Track designation for ATH434, its lead candidate for treating Multiple System Atrophy, potentially speeding up regulatory review and bringing hope to patients with this rare neurodegenerative disorder.

HeraMED reports strong Q1 FY25 progress with 4,282 registered users on its HeraCARE platform, a new collaboration with Garmin Health, and advancing commercial deals in the US and Europe. Early clinical data suggests improved maternal outcomes and operational efficiencies.

Anatara Lifesciences reports mixed results from its Phase II GaRP-IBS trial, missing the primary efficacy target but showing significant improvements in anxiety and patient-reported relief, while advancing its anti-obesity pre-clinical program.

Clarity Pharmaceuticals reports a robust cash position and strategic refocus on its lead prostate cancer asset, Cu-SAR-bisPSMA, supported by multiple FDA Fast Track designations and advancing clinical trials.

Vectus Biosystems advances its lead fibrosis drug VB0004 with validated Phase I safety data and strategic cost reductions, while actively pursuing licensing partnerships in China.

Tissue Repair Limited reports progress in its Phase 3 clinical trials for TR987® despite enrollment delays caused by US regulatory disruptions, while TR Pro+® sales hit record highs and manufacturing scale-up advances.