The neurology landscape advanced on multiple fronts today, spanning rare pediatric disease regulation, progressive multiple sclerosis setbacks, epilepsy drug financing, augmented-reality–guided neurosurgery, and expanded commercial reach for psychiatric therapies in Asia. Together, these developments reflect a field balancing regulatory scrutiny with accelerating innovation, particularly in rare disorders, surgical precision, and infrastructure that shortens the path from diagnosis to treatment.
Zuellig Pharma Expands Asia Commercial Footprint for Lundbeck’s CNS Portfolio
Zuellig Pharma broadened its partnership with Lundbeck to provide full commercialization support for key neuro-psychiatric brands, including Lexapro, Brintellix, and Cipralex across Southeast Asia and Taiwan. The expanded agency model moves beyond distribution into market access, regulatory support, and pharmacovigilance, strengthening Lundbeck’s regional execution as demand for mental health treatments continues to rise across Asia-Pacific markets.
Mass General Brigham Spins Out AI Platform to Accelerate Trial Enrollment
Mass General Brigham launched AIwithCare, a new company built around its RECTIFIER platform, which uses retrieval-augmented generative models to screen electronic health records for clinical trial eligibility. In randomized studies, the system nearly doubled enrollment rates compared with manual screening, with applications already extending into neurology, oncology, cardiology, and rare disease trials, addressing one of the most persistent bottlenecks in clinical research execution
Aeovian Raises $55M to Push Selective mTORC1 Inhibitor in Epilepsy
Aeovian Pharmaceuticals closed an oversubscribed $55 million Series B financing to advance AV078, a CNS-penetrant, selective mTORC1 inhibitor, into a Phase 2 proof-of-concept study for tuberous sclerosis complex–related refractory epilepsy. Unlike existing nonselective mTOR inhibitors, AV078 is designed to avoid mTORC2-related toxicities, addressing a core biological driver of seizures in a population where two-thirds of patients remain refractory to current options.
Ambros Therapeutics Launched with $125 Million in Financing
Ambros Therapeutics launched with $125 million in funding to advance a first-in-class, non-opioid pain program, backed by Vivek Ramaswamy and built on human genetics–driven neuroscience. The company aims to move its lead asset into the clinic, targeting chronic pain, re-igniting investor interest in differentiated analgesics after years of high-profile failures in the space.
Medivis Wins First FDA Clearance for AR-Guided Cranial Neurosurgery
Medivis became the first company to receive FDA 510(k) clearance for an augmented reality cranial navigation platform, enabling real-time intraoperative guidance directly within the surgeon’s field of view. The portable system extends image-guided precision beyond the operating room into ICU and bedside settings, with early data suggesting meaningful reductions in misplacement rates for procedures such as external ventricular drain insertion, an advance that could materially improve neurosurgical safety and workflow efficiency.
FDA Resets Review Clock for First Potential Menkes Disease Therapy
Sentynl Therapeutics secured FDA acceptance of its resubmitted NDA for CUTX-101 (copper histidinate), restarting the regulatory timeline with a new PDUFA date of January 14, 2026. The resubmission was classified as Class I and addressed manufacturing-related cGMP observations raised in a prior complete response letter, without new concerns tied to efficacy or safety. If approved, CUTX-101 would become the first FDA-approved treatment for Menkes disease, a rare and often fatal pediatric neurogenetic disorder, with clinical data showing substantial survival gains when administered early.
Sanofi Halts PPMS Filing After Phase 3 Miss
Sanofi disclosed that its PERSEUS Phase 3 study of tolebrutinib in primary progressive multiple sclerosis failed to meet its primary endpoint of delaying confirmed disability progression. While the safety profile remained consistent with prior trials, the outcome prompted Sanofi to abandon regulatory filings for PPMS. The company reiterated its confidence in tolebrutinib’s potential in non-relapsing secondary progressive MS, where regulatory reviews remain ongoing in several regions.
Last week’s NeuroPulse
Last week’s NeuroPulse highlighted how neurology was consolidating around behavioral health integration, rare neuromuscular disease regulation, and neurodiagnostic interoperability, alongside breakthrough momentum in ultra-rare pediatric disorders. Today’s edition extends that trajectory, showing how regulatory engagement has translated into concrete FDA action, capital deployment, and technology clearances that move innovation closer to real-world execution.
