Clinical Trials

BioVie says its ADDRESS-LC Phase 2 trial of bezisterim has finished dosing, with topline results expected before end of September 2026.

The Nasdaq-listed medtech said its fingerprint sweat drug screening system achieved 98.2% accuracy in a three-site study, with a 510(k) submission

The FDA granted Breakthrough Therapy Designation to JBS-003, a hypoxia tracer designed to halve radiation doses in HPV-positive head and neck cancer.

Kala Bio will market Virotek's CLIA-registered ophthalmology genetic screening programme across U.S. eye care practices, targeting a definitive deal within 30 days.

Kyntra Bio has amended its royalty financing deal to reduce maximum aggregate payments from $125m to $65m, extending its cash runway into Q4 2027.

The REMODEL-1/-2 trials showed remibrutinib significantly reduced relapse rates versus teriflunomide, with disability progression benefits and no liver safety signal.

Ocugen has initiated its Phase 3 ArMaDa3 trial of OCU410 for geographic atrophy, backed by FDA RMAT designation and a BLA filing targeted for 2028.

Telix has finished enrolling 350 patients in its Phase 3 pre-biopsy PSMA-PET study and confirmed an NDA pathway with the FDA that could

Peer-reviewed results show a 61% mean reduction in daily cornstarch intake at Week 96, with glycaemic control maintained across both treatment groups.

The Waltham biotech will start pivotal studies in severe asthma and CRSwNP in Q1 2027, targeting a quarterly 400 mg subcutaneous regimen.

Discovery Health reports female members complete 1.5 times more preventive health actions than male members on its AI-powered Personal Health Pathways platform.

The Canadian biotech cleared a central IRB review for its Phase II LSALT peptide study, bringing five U.S. institutions closer to activation.

Beyond Air's portable inhaled nitric oxide device gains FDA Breakthrough Device Designation for a rare, hard-to-treat chronic lung infection.

The FDA agreed on the primary endpoint and placebo-control design for Cadrenal's Phase 3 trial of its 12-LOX inhibitor in heparin-induced

Disc Medicine will share Phase 2 safety and efficacy data for two antibody candidates targeting myeloproliferative neoplasms at SOHO in Houston this September.

The French-American biotech has hired a 30-year industry veteran to lead operational and commercial readiness as its lanifibranor Phase 3 data approaches.

Twelve-month Phase 1/2a data showed 80% of patients normalised cardiac filling pressures after a single dose of the SERCA2a gene therapy.

Palvella Therapeutics has filed its full NDA with the FDA for QTORIN rapamycin gel, targeting a rare condition with no approved treatment options.

Updated interim PYNNACLE data show a 10-month median duration of response, as PMV plans an NDA submission for accelerated approval in Q1 2027.

XYRA LLC has dosed the first patient in Poland in HARBOR-AF, a Phase 2/3 study using wearable and implanted monitors to guide antiarrhythmic