CNS Gene Therapy Trials Are About to Break Every Monitoring Assumption Your CRO Has
BBM-P002's multicenter Phase 1 Parkinson's data signals a wave of CNS gene therapy trials that will overwhelm standard eClinical...
The Single Phase 3 Default Is Already Changing How Sites Get Activated — Are You Ready?
FDA's February 2026 single-trial default standard is compressing enrollment timelines and reshaping site contracts. Here's what ops teams must...
Elixiron’s Enrupatinib Shows Neuroinflammation Reduction in Phase 2 Alzheimer’s Trial
Elixiron's enrupatinib reduced neuroinflammation signals by over 30% in biomarker-selected Alzheimer's patients within 28 days of dosing.
IMAAVY meets primary endpoint in Phase 2/3 warm autoimmune hemolytic anemia trial
Nipocalimab met its primary endpoint in the Phase 2/3 ENERGY trial for warm autoimmune hemolytic anemia, with nearly two-thirds...
Novartis del-brax meets primary endpoints in FSHD Phase I/II study
Novartis del-brax Phase I/II study met primary endpoints, reducing KHDC1L and creatine kinase in FSHD patients over 12 months...
Health Canada Grants Priority Review to Italfarmaco’s Givinostat for Duchenne Muscular Dystrophy
Health Canada grants Priority Review to Italfarmaco's Givinostat for Duchenne muscular dystrophy, with a 180-day regulatory decision target by...
Single-Cell Spatial Pharmacobiology Just Changed What “Drug Delivery” Means in Solid Tumor Trials
A Nature Biotechnology study using Single-cell Spatial Pharmacobiology exposes heterogeneous antibody delivery in solid tumors—what sponsors assumed about…
Why Pilots Don’t Scale: The Case for Pre-Protocol Invariants in Clinical Development
A leading sponsor hit 79% site adoption and called it a ceiling. The fix isn’t better tools—it’s pre-protocol invariants...
Kymera’s KT-485 Enters Phase 1 Trial Under $20M Sanofi Deal
Kymera's KT-485 enters Phase 1 testing for hidradenitis suppurativa under a $20M Sanofi partnership with up to $975M in...
TG Therapeutics Begins Phase 2 Trial of BRIUMVI in Myasthenia Gravis
TG Therapeutics launches Phase 2 trial of BRIUMVI in myasthenia gravis, testing sequential therapy with efgartigimod for sustained B-cell...