North America

WuXi AppTec argues that extrahepatic oligonucleotide delivery requires tissue-specific strategies, not a single universal technology.

The Israel-based dual-business company reported FDA IND clearance for its intraocular drug-delivery ring and positive preclinical data for its non-opioid pain

Four-year open-label extension data showed durable seizure reductions and cognitive gains in Dravet syndrome; Phase 3 readout is expected in Q3 2027.

The London RNAi biotech said its siRNA candidate cleared a safety review in healthy volunteers and now enters multiple ascending dose testing in MASH patients.

Vaxcyte has appointed two senior executives and narrowed its OPUS-1 Phase 3 topline data window to end of October 2026.

The Worcester-based medical robotics firm secured a $2m NIH SBIR Phase II award to develop MRI-compatible robotic ablation for intracranial tumours.

The San Carlos biotech reported preliminary proof of concept for ATTO-1310 in chronic pruritus and atopic dermatitis, with two Phase 2 studies planned for

Topline results for lanifibranor's pivotal 1,009-patient trial are expected in Q4 2026, with regulatory submission targeted for H1 2027 if data are

Nyxoah's Genio device achieved a 77.2% AHI responder rate with zero serious device-related adverse events, clearing the path for a US PMA

The North Carolina gene therapy company will share Cohort 1 topline results for its BEST1 retinal disease programme at an investor webcast and three ophthalmology

The Alameda-based CRISPR company began a Phase 1 trial of its epigenetic LDL-C therapy and secured $25m in non-dilutive CIRM grants alongside

Teva's anti-IL-15 antibody TEV-408 significantly reduced gluten-induced intestinal damage versus placebo in a 50-patient Phase 2a study.

Ultragenyx's apazunersen missed both its primary and key secondary endpoints in the Phase 3 Aspire study, leaving Angelman syndrome without an approved treatment.

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.

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