This week’s Neuroscience update highlights regulatory actions, clinical progress, CNS oncology advances, and data releases across key neurological indications.
In Today’s Newsletter
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🧬 Itvisma gains CHMP backing for broader SMA use [1] [EU • 24 Apr 2026]
https://www.novartis.com/news/media-releases/novartis-receives-positive-chmp-opinion-itvisma-spinal-muscular-atrophy-sma
Context: STEER showed a 2.39-point HFMSE improvement versus 0.51 with sham over 52 weeks; supportive data came from STRENGTH and STRONG.
Key point: Novartis received a CHMP positive opinion for Itvisma in 5q SMA with bi-allelic SMN1 mutation for children two years and older, teens, and adults.
Implication: May influence prescriber choice and payer reviews pending full data.
🛡️ IMAAVY shows sustained gMG control beyond two years [2] [US • 22 Apr 2026]
https://www.jnj.com/media-center/press-releases/imaavy-nipocalimab-aahu-shows-over-two-years-of-sustained-disease-control-in-a-broad-population-with-generalized-myasthenia-gravis-gmg
Context: Vivacity-MG3 and OLE data included anti-AChR+ and anti-MuSK+ adults; EPIC is enrolling as a head-to-head FcRn blocker study.
Key point: Johnson & Johnson said IMAAVY (nipocalimab-aahu) sustained disease-control measures in antibody-positive adult gMG through 120 weeks.
Implication: May influence prescriber choice and payer reviews pending full data.
🧠 CAPLYTA label expands with schizophrenia relapse data [3] [US • 27 Apr 2026]
https://www.jnj.com/media-center/press-releases/fda-approves-caplyta-lumateperone-snda-with-robust-new-data-supporting-reduced-risk-of-relapse-in-schizophrenia
Context: In a Phase 3 randomized withdrawal trial, CAPLYTA reduced relapse risk by 63% versus placebo; 84% of patients were relapse-free over six months.
Key point: FDA approved Johnson & Johnson’s CAPLYTA (lumateperone) sNDA for prevention of relapse in schizophrenia.
Implication: May influence prescriber choice and payer reviews pending full data.
🧩 Cenrifki receives CHMP recommendation for non-relapsing SPMS [4] [EU • 24 Apr 2026]
https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-24-10-09-46-3280641
Context: The recommendation is based on HERCULES Phase 3 data; DILI is an identified safety risk requiring liver monitoring.
Key point: Sanofi’s Cenrifki (tolebrutinib) received a CHMP positive opinion for SPMS without relapses in the prior two years.
Implication: May influence prescriber choice and payer reviews pending full data.
📉 Fenebrutinib reduces RMS relapses versus teriflunomide [5] [21 Apr 2026]
https://www.roche.com/media/releases/med-cor-2026-04-21c
Context: Phase 3 FENhance studies ran over 96 weeks; liver enzyme elevations were comparable with teriflunomide, with reported deaths imbalanced across studies.
Key point: Roche said investigational fenebrutinib reduced ARR by 51.1% in FENhance 1 and 58.5% in FENhance 2 versus teriflunomide.
Implication: May influence prescriber choice and payer reviews pending full data.
🎗️ Ojemda wins EU conditional approval in pediatric low-grade glioma [6] [EU • 22 Apr 2026]
https://www.ipsen.com/press-release/ojemda-approved-in-the-european-union-as-the-first-targeted-therapy-in-relapsed-or-refractory-pediatric-low-grade-glioma-regardless-of-braf-alteration-3278647/
Context: FIREFLY-1 evaluated 137 children and young adults; ORR was 71% by RANO-HGG and 53% by RAPNO-LGG.
Key point: Ipsen received EC conditional marketing authorization for Ojemda (tovorafenib) in relapsed or refractory BRAF-altered pediatric low-grade glioma.
Implication: May influence prescriber choice and payer reviews pending full data.
🏭 Plus Therapeutics starts REYOBIQ manufacturing activities with SpectronRx [7] [US • 23 Apr 2026]
https://ir.plustherapeutics.com/news-releases/news-release-details/plus-therapeutics-initiates-manufacturing-activities-spectronrx
Context: SpectronRx is positioned as a second GMP manufacturing site alongside Radiomedix, with Rhenium-186 supplied through Telix Pharmaceuticals.
Key point: Plus Therapeutics initiated manufacturing activities and technology transfer with SpectronRx to support REYOBIQ late-stage clinical supply.
Implication: Signals pipeline investment and modality expansion.
🧬 IBTROZI added to NCCN CNS cancer guidelines [8] [US • 27 Apr 2026]
https://www.prnewswire.com/news-releases/nuvation-bio-announces-national-comprehensive-cancer-network-adds-taletrectinib-ibtrozi-as-recommended-option-to-clinical-practice-guidelines-in-oncology-for-central-nervous-system-cancers-302753406.html
Context: The source cites intracranial response rates of 76.5% in TKI-naive patients and 65.6% in TKI-pretreated patients, presented at AACR 2026.
Key point: Nuvation Bio said NCCN added taletrectinib (IBTROZI) as a systemic option for ROS1+ NSCLC with brain metastases in CNS cancer guidelines.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it Matters
- EU regulatory activity was prominent, with CHMP or EC decisions for Itvisma, Cenrifki, and Ojemda.
- Multiple sclerosis remains active for BTK inhibitors, with Sanofi advancing tolebrutinib in non-relapsing SPMS and Roche reporting fenebrutinib Phase 3 RMS data.
- CNS oncology updates spanned approval, guidelines, and manufacturing readiness across Ojemda, IBTROZI, and REYOBIQ.
- Johnson & Johnson strengthened neuroscience positioning with gMG durability data and a schizophrenia relapse-prevention label update.
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FAQ
What is Itvisma (Novartis) being reviewed for in the EU?
Itvisma is under CHMP positive opinion for 5q SMA with bi-allelic SMN1 mutation in children two years and older, teens, and adults. The EC decision is expected after the CHMP recommendation process. [1]
What did Johnson & Johnson report for IMAAVY in gMG?
J&J reported sustained clinical improvements and IgG reductions through 120 weeks in antibody-positive adults with gMG, including anti-AChR+ and anti-MuSK+ groups. [2]
What changed for CAPLYTA (lumateperone) in schizophrenia?
FDA approved a CAPLYTA sNDA supported by long-term Phase 3 data for prevention of relapse in schizophrenia. The source reports a 63% lower relapse risk versus placebo. [3]
How do Cenrifki and fenebrutinib differ in this week’s MS updates?
Cenrifki (Sanofi) received a CHMP positive opinion for non-relapsing SPMS, while fenebrutinib (Roche) reported Phase 3 RMS relapse reductions versus teriflunomide. [4][5]
What population is covered by Ojemda’s EU approval?
Ojemda is conditionally approved as monotherapy for patients six months and older with relapsed or refractory pediatric low-grade glioma harboring a BRAF fusion, rearrangement, or BRAF V600 mutation. [6]
Why is IBTROZI’s NCCN CNS guideline inclusion relevant?
Nuvation Bio said taletrectinib was added as a systemic therapy option for ROS1+ NSCLC patients with brain metastases in NCCN CNS cancer guidelines. [8]
Entities / Keywords
Novartis: Itvisma, intrathecal onasemnogene abeparvovec, SMA, 5q SMA, SMN1, STEER, STRENGTH, STRONG, HFMSE
Johnson & Johnson: IMAAVY, nipocalimab-aahu, gMG, generalized myasthenia gravis, Vivacity-MG3, FcRn blocker, EPIC
Johnson & Johnson: CAPLYTA, lumateperone, schizophrenia, relapse prevention, sNDA, randomized withdrawal
Sanofi: Cenrifki, tolebrutinib, SPMS, secondary progressive multiple sclerosis, HERCULES, GEMINI 1, GEMINI 2, DILI
Roche: fenebrutinib, BTK inhibitor, RMS, relapsing multiple sclerosis, FENhance 1, FENhance 2, teriflunomide, ARR
Ipsen: Ojemda, tovorafenib, pediatric low-grade glioma, pLGG, BRAF alteration, FIREFLY-1, RANO-HGG, RAPNO-LGG
Plus Therapeutics: REYOBIQ, Rhenium-186, SpectronRx, Radiomedix, Telix Pharmaceuticals, GMP manufacturing, CNS cancers
Nuvation Bio: taletrectinib, IBTROZI, ROS1+ NSCLC, brain metastases, NCCN Guidelines, CNS cancers
References
- https://www.novartis.com/news/media-releases/novartis-receives-positive-chmp-opinion-itvisma-spinal-muscular-atrophy-sma
- https://www.jnj.com/media-center/press-releases/imaavy-nipocalimab-aahu-shows-over-two-years-of-sustained-disease-control-in-a-broad-population-with-generalized-myasthenia-gravis-gmg
- https://www.jnj.com/media-center/press-releases/fda-approves-caplyta-lumateperone-snda-with-robust-new-data-supporting-reduced-risk-of-relapse-in-schizophrenia
- https://www.sanofi.com/en/media-room/press-releases/2026/2026-04-24-10-09-46-3280641
- https://www.roche.com/media/releases/med-cor-2026-04-21c
- https://www.ipsen.com/press-release/ojemda-approved-in-the-european-union-as-the-first-targeted-therapy-in-relapsed-or-refractory-pediatric-low-grade-glioma-regardless-of-braf-alteration-3278647/
- https://ir.plustherapeutics.com/news-releases/news-release-details/plus-therapeutics-initiates-manufacturing-activities-spectronrx
- https://www.prnewswire.com/news-releases/nuvation-bio-announces-national-comprehensive-cancer-network-adds-taletrectinib-ibtrozi-as-recommended-option-to-clinical-practice-guidelines-in-oncology-for-central-nervous-system-cancers-302753406.html