This neuroscience update highlights major advances in neurology from leading biopharma companies. Zenas BioPharma licensed Orelabrutinib from InnoCare for progressive MS, while BioNxt Solutions fast-tracked a US patent for a sublingual cladribine film. Roche and Lilly gained FDA approval for an Alzheimer’s blood test, and Theranica’s Nerivio® showed strong data in pediatric migraine. Additional highlights include Taysha’s TSHA-102 for Rett syndrome, Biogen and Stoke’s Zorevunersen for Dravet syndrome, and Cadenza’s ERβ-targeting compounds K102 and K110 for remyelination. Mandos Health’s Adrabetadex improved survival in NPC, and a Lilly–WHO Foundation partnership aims to enhance global dementia care.
🧪 Zenas BioPharma Licenses Orelabrutinib for Progressive MS [1]
Context: Zenas has secured global rights to Orelabrutinib, a BTK inhibitor, for progressive MS.
Key Point: Phase 3 trials for Primary Progressive MS (PPMS) are underway, with Secondary Progressive MS (SPMS) trials planned for 2026.
Implication: Orelabrutinib could offer a disease-modifying treatment option for progressive MS, an area of high unmet need.
🏥 BioNxt Solutions Fast-Tracks Patent for Sublingual Cladribine [2] Published: 09 Oct 2025
Context: BioNxt has filed a fast-track patent for a sublingual thin-film formulation of cladribine aimed at improving bioavailability and patient compliance in MS.
Key Point: The formulation could provide a more convenient treatment method, potentially improving patient adherence.
Implication: If successful, this new delivery system could reshape the landscape for MS treatment options.
✅ Roche & Lilly’s FDA-Approved Blood Test for Alzheimer’s Diagnosis [3] Published: 13 Oct 2025
Context: Roche, in partnership with Eli Lilly, has received FDA approval for the Elecsys test, which measures pTau181, a protein associated with Alzheimer’s disease.
Key Point: The test is intended for individuals aged 55 and older showing signs of cognitive decline, with a 97.9% negative predictive value in ruling out Alzheimer’s.
Implication: This marks a significant step forward in Alzheimer’s diagnostics, offering a quick, accessible, and less invasive alternative to traditional methods.
⏱️ Theranica’s Nerivio® Wearable for Pediatric Migraine [4] Published: 08 Oct 2025
Context: Theranica’s Nerivio wearable device, a drug-free solution for pediatric migraines, shows strong real-world data on its efficacy in treating migraines.
Key Point: The wearable device demonstrated sustained efficacy and safety in real-world settings.
Implication: The device could provide a valuable non-pharmacologic treatment option, especially in pediatric populations.
🎯Taysha Gene Therapies’ TSHA-102 Shows Broad Gains in Rett Syndrome [5] Published: 09 Oct 2025
Context: New data from the REVEAL Phase 1/2 trials for TSHA-102 in Rett syndrome show a 100% response rate and improvements across multiple disease domains.
Key Point: Patients showed significant improvements in motor, communication, and autonomic functions.
Implication: TSHA-102 continues to show promise as a transformative gene therapy for Rett syndrome.
🔬 Biogen and Stoke’s Zorevunersen for Dravet Syndrome [6] Published: 09 Oct 2025
Context: Zorevunersen, in open-label extension studies, demonstrated sustained cognitive and behavioral improvements in Dravet syndrome patients.
Key Point: Data shows improvements in cognition and behavior, with reductions in major motor seizures.
Implication: Zorevunersen could become a key treatment for Dravet syndrome, addressing both seizures and cognitive/behavioral challenges.
💊 Cadenza Bio’s ERβ Ligands Promote Remyelination in MS Models [7] Published: 09 Oct 2025
Context: Cadenza Bio’s lead compounds K102 and K110, targeting estrogen receptor beta (ERβ), show dual benefits in preclinical MS models.
Key Point: The compounds enhanced remyelination and functional recovery, showing significant potential for treating MS.
Implication: Strong preclinical evidence supports progression to clinical trials for these novel small molecules.
🧬 Adrabetadex Shows Survival Benefit in Niemann-Pick Disease Type C [8] Published: 13 Oct 2025
Context: Adrabetadex, a treatment for Niemann-Pick Disease Type C (NPC), demonstrated a significant survival benefit for patients in clinical trials.
Key Point: Adrabetadex treatment improved survival rates and biomarkers linked to NPC’s underlying pathology.
Implication: Adrabetadex could offer a life-saving treatment for NPC, a rare and devastating neurodegenerative disorder.
🧠Hesperos & Bayer Study Cortisol’s Effects on Stress-Induced Cognitive Decline [9] Published: 13 Oct 2025
Context: Hesperos and Bayer have published a study modeling the effects of cortisol exposure on neuronal networks, relevant to stress-related cognitive decline.
Key Point: Chronic cortisol exposure impaired neuronal network activity and long-term potentiation (LTP).
Implication: The study could lead to better models for understanding and treating stress-induced cognitive decline.
🌍 WHO Foundation & Lilly Collaboration to Improve Dementia Care [10] Published: 13 Oct 2025
Context: WHO Foundation and Lilly are collaborating to improve global dementia care, focusing on early diagnosis, risk reduction, and treatment access.
Key Point: This partnership aims to enhance dementia care in low- and middle-income countries, expanding access to diagnostic and treatment options.
Implication: The collaboration may significantly improve global access to dementia care, particularly in underserved regions.
Why it Matters
- Zenas BioPharma’s Orelabrutinib could provide a novel, disease-modifying treatment for progressive MS [1].
- BioNxt Solutions’s sublingual cladribine formulation could enhance treatment adherence for MS patients [2].
- Roche & Lilly’s FDA-approved blood test could significantly speed up Alzheimer’s diagnosis, making treatments more accessible and improving patient care [3].
- Theranica’s Nerivio wearable presents a promising drug-free solution for pediatric migraines [4].
- Taysha Gene Therapies’ TSHA-102 continues to demonstrate strong potential for treating Rett syndrome with broad functional improvements [5].
- Biogen and Stoke’s Zorevunersen shows long-term benefits for Dravet syndrome patients, potentially transforming treatment [6].
- Cadenza Bio’s ERβ ligands represent a potential first-in-class treatment for MS, with preclinical data showing significant benefits in remyelination and functional recovery [7].
- Mandos Health’s adrabetadex offers hope for patients with NPC, with promising survival and biomarker data [8].
- Hesperos & Bayer’s model for stress-induced cognitive decline could open new avenues for treatment [9].
- WHO Foundation & Lilly’s collaboration aims to improve global dementia care and accessibility [10].
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FAQ
What is the status of Orelabrutinib for MS?
Orelabrutinib, a BTK inhibitor, is currently in Phase 3 trials for Primary Progressive MS (PPMS), with Secondary Progressive MS (SPMS) trials scheduled for 2026 [1].
What is BioNxt’s new MS drug delivery system?
BioNxt’s sublingual thin-film cladribine formulation is designed to improve drug bioavailability and patient compliance for MS treatment, offering a more convenient option for patients [2].
How will Roche & Lilly’s blood test change Alzheimer’s diagnosis?
Roche’s Elecsys blood test, now FDA-approved, offers a more accessible and less invasive method for diagnosing Alzheimer’s disease, which could lead to faster diagnosis and better treatment access [3].
How does Theranica’s Nerivio wearable work?
Nerivio is a drug-free, smartphone-controlled wearable device that has shown efficacy in treating pediatric migraines, providing an alternative to pharmacological treatments [4].
What is Zorevunersen’s impact on Dravet syndrome?
Zorevunersen has shown sustained reductions in seizures and improvements in cognition and behavior, offering a promising disease-modifying treatment for Dravet syndrome [6].
What do Cadenza Bio’s ERβ ligands do for MS?
The compounds, K102 and K110, target estrogen receptor beta and promote remyelination and functional recovery in MS models, making them promising candidates for clinical trials [7].
What is Adrabetadex’s role in NPC treatment?
Adrabetadex has demonstrated a significant survival benefit for NPC patients, addressing the disease’s core pathology and offering hope for a life-saving treatment [8].
How does Hesperos & Bayer’s cortisol study help?
The study models the effects of chronic cortisol exposure on brain function, which could lead to better treatment strategies for stress-related cognitive decline [9].
What is the WHO Foundation & Lilly’s dementia collaboration about?
The partnership aims to improve dementia care globally, focusing on early detection and treatment access, especially in low-income regions [10].
Entities / Keywords
Cadenza Bio; ERβ ligands; Orelabrutinib; Zenas BioPharma; BTK inhibitor; BioNxt Solutions; cladribine; Theranica; Nerivio; Taysha Gene Therapies; TSHA-102; Biogen; Stoke Therapeutics; Zorevunersen; Mandos Health; Adrabetadex; Hesperos; Bayer; WHO Foundation; dementia care; Alzheimer’s disease; Roche Diagnostics; Eli Lilly; Elecsys; Alzheimer’s blood test.
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