Neuroscience Weekly News - September 24th 2025

🧠 This Week in Neuroscience: Ocrelizumab Safety, MAVENCLAD Durability, ECTRIMS Insights, & More

Stay current with pivotal MS developments! This week’s roundup highlights safer B-cell therapies, promising long-term outcomes, and key ECTRIMS presentations—plus regulatory delays on BTK inhibitors, ground-breaking neurodegenerative collaborations, and streamlined diagnostic criteria aimed at earlier MS detection and broader patient access.

In Today’s Newsletter

🧪 Ocrelizumab shows safer profile vs rituximab in MS [1]

https://www.rarediseaseadvisor.com/news/ocrelizumab-offer-better-outcomes-rituximab-ms/

Context: Retrospective multicenter observational study (>1,400 adults) across 6 California sites; discovery + validation cohorts.

Key point: Lower hospitalization, infection, and hypogammaglobulinemia rates reported with ocrelizumab vs rituximab (endpoint specifics not stated).

Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

📊 Merck to showcase durable MAVENCLAD data at ECTRIMS [2] [EU • 17 Sep 2025]

https://www.merckgroup.com/en/news/curtain-raiser-ectrims-17-09-2025.html

Context: >30 abstracts; integrated 4-year data from CLARIFY-MS (n=482) and MAGNIFY-MS (n=270) with extensions.

Key point: Reports low disability progression (including PIRA) and biomarker/brain-volume signals consistent with durable efficacy (details per poster/analysis).

Implication: May influence prescriber choice and payer reviews pending full data.

🤝 Neuraxpharm & TG Therapeutics bring RRMS insights to ECTRIMS [3]

https://www.prnewswire.com/news-releases/neuraxpharm-participates-in-ectrims-reinforcing-its-commitment-to-multiple-sclerosis-302563080.html

Context: ECTRIMS 2025 (Barcelona, 24–26 Sep); booth talks plus clinical and real-world evidence in RRMS.

Key point: Companies highlight data supporting access and clinical use across Europe (endpoints not specified).

Implication: Signals pipeline investment and modality expansion.

🧠 FDA delays Sanofi’s tolebrutinib decision in nrSPMS [4][5] [US • 22 Sep 2025]

https://www.sanofi.com/en/media-room/press-releases/2025/2025-09-22-05-00-00-3153624

Context: NDA for oral, brain-penetrant BTK inhibitor for nrSPMS and to slow disability accumulation independent of relapse activity.

Key point: FDA deemed new analyses a major amendment; target action date extended to 28 Dec 2025; package references HERCULES and GEMINI 1/2.

Implication: May influence prescriber choice and payer reviews pending full data.

🚀 JCR & Alexion hit milestone in CNS cargo program [6]

https://www.biospace.com/press-releases/jcr-pharmaceuticals-and-alexion-achieve-milestone-in-collaborative-neurodegenerative-disease-program

Context: Collaboration applies JCR’s J-Brain Cargo® to a neurodegenerative disease; follows Dec 2023 oligo pact and Jul 2025 JUST-AAV license.

Key point: Milestone triggers payment; included in JCR FY2025 (ending 31 Mar 2026) outlook (indication not specified).

Implication: Signals pipeline investment and modality expansion.

🩺 2024 McDonald criteria update aims faster MS diagnosis [7]

https://www.prnewswire.com/news-releases/national-multiple-sclerosis-society-leads-the-way-in-making-it-easier-to-diagnose-ms-302560615.html

Context: International committee (sponsored by NMSS & ECTRIMS); update published in Lancet Neurology.

Key point: Adds new tests, pediatric/≥50 guidance; seeks broader, less invasive access; existing diagnoses unchanged.

Implication: May expand screening, initiation, and follow-up at scale.

Why it matters

Head-to-head real-world comparisons of B-cell agents can shift treatment selection and monitoring strategies. [1]
Durable efficacy signals and brain-volume trends with MAVENCLAD may support earlier use in RMS if confirmed. [2]
Regulatory delays for BTK inhibitors affect nrSPMS options and market timing into 2026. [4][5]
Platform delivery tech (J-Brain Cargo®, JUST-AAV) underscores investment in CNS penetration for large modalities. [6]
Updated diagnostic criteria can compress time-to-diagnosis and standardize testing pathways globally. [7]

📢 Stay Ahead in Neuroscience Research!

✅ Contact LucidQuest at info@lqventures.com for strategic guidance on neuroscience and breakthrough therapies

FAQ

What did the ocrelizumab vs rituximab study actually show?
An observational, multicenter analysis reported lower hospitalization, infection, and hypogammaglobulinemia rates with ocrelizumab compared with rituximab; specific effect sizes weren’t provided in the summary. [1]

What’s new about MAVENCLAD at ECTRIMS 2025?
Merck KGaA is presenting >30 abstracts, including integrated 4-year Phase 4 data suggesting low disability progression (including PIRA) and supportive biomarker/brain-volume findings. Full details reside in the abstracts/posters. [2]

Why was Sanofi’s tolebrutinib decision delayed?
FDA received additional analyses deemed a major amendment, moving the target action date to 28 Dec 2025. The review references HERCULES (nrSPMS) and GEMINI 1/2 (RMS). [4][5]

Does the McDonald criteria update change existing MS diagnoses?
No. The 2024 update is intended to speed and refine diagnosis (including for children and adults ≥50) but does not alter prior diagnoses. [7]

What is J-Brain Cargo® and why does it matter?
It’s JCR’s blood-brain barrier-penetrating delivery platform for biotherapeutics; the Alexion collaboration reached a milestone payment stage, indicating program progress. [6]

What is Neuraxpharm doing at ECTRIMS?
With TG Therapeutics, Neuraxpharm is hosting expert booth talks and sharing RRMS clinical and real-world data to support access and adoption in Europe. [3]

Entities / Keywords

Ocrelizumab (Genentech/Roche); Rituximab; B-cell therapy; Hospitalization; Hypogammaglobulinemia — MAVENCLAD (cladribine tablets; Merck KGaA/EMD Serono); PIRA; Brain volume — Neuraxpharm; TG Therapeutics; RRMS — Tolebrutinib (Sanofi; BTK inhibitor); nrSPMS; FDA; HERCULES; GEMINI — JCR Pharmaceuticals; Alexion (AstraZeneca Rare Disease); J-Brain Cargo®; JUST-AAV — National MS Society; ECTRIMS; McDonald criteria (2024).