Gene Therapy Just Delivered Dopamine Directly Into the Brain. Now Comes the Hard Part.
BBM-P002's Phase 1 data in 10 Parkinson's patients shows dual-target AAV gene therapy can restore dopamine synthesis. The FDA...
CNS Trials
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...
Psychedelic Trials Are Producing Stunning Numbers. The Methodology Underneath Them May Not Hold.
Luvesilocin's 70% PPD remission rate and psilocybin-CBT pilot data are turning heads—but sex-specific blind spots and a therapy model...
BIOMEDE Missed Its Primary Endpoint — And Still Changed Pediatric CNS Trial Design Forever
The BIOMEDE Phase 2 trial in DIPG missed OS superiority but exposed a biomarker-survival link that should rewrite how...
The Alzheimer’s Prevention Trial Has No Finish Line — Until Now
A new set of target product profiles published in Nature Medicine attempts to define what a successful preventive Alzheimer's...
The $30 Million Bet: CNS Investors Are Back — and Registrational Trial Design Hasn’t Kept Up
Serina Therapeutics just closed a $30 million private placement at a 68% premium to fund a registrational trial for...