This week’s Neuroscience update highlights regulatory progress, advancing multiple sclerosis and Parkinson’s programs, emerging cell therapies, and growing payer focus on migraine treatment costs.
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💉 TEV-749 EMA filing accepted for schizophrenia [1] [EU • 21 May 2026]
https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/The-European-Medicines-Agency-Accepts-Tevas-Marketing-Authorization-Application-for-Olanzapine-Long-Acting-Injectable-TEV-749-for-the-Treatment-of-Schizophrenia-in-Adults/default.aspx
Context: Teva and Medincell submitted TEV-749, a monthly subcutaneous olanzapine LAI, for adults with schizophrenia.
Key point: EMA accepted the MAA; TEV-749 is not approved by any regulatory authority worldwide.
Implication: May influence prescriber choice and payer reviews pending full data.
🧠 Foralumab Expanded Access data in na-SPMS [2] [US • 19 May 2026]
https://www.tizianalifesciences.com/tiziana-announces-new-positive-clinical-data-for-intranasal-foralumab-in-non-active-secondary-progressive-multiple-sclerosis/
Context: Tiziana reported updated March 2025–March 2026 data from 14 na-SPMS patients in an Expanded Access program.
Key point: Intranasal foralumab was well tolerated, with directional EDSS stabilization and MFIS fatigue improvement trends.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧬 INFORM-MS Phase 2a fully enrolled [3] [US • 21 May 2026]
https://www.tizianalifesciences.com/tiziana-fully-enrolls-its-phase-2-placebo-controlled-multiple-sclerosis-trial/
Context: INFORM-MS enrolled 48 na-SPMS patients across US sites for 12 weeks of foralumab or placebo.
Key point: Tiziana completed enrollment; topline data are expected in late Q3 2026 and at ACTRIMS–ECTRIMS in Oct 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 BIIB122 misses Phase 2b Parkinson’s endpoints [4] [US • 21 May 2026]
https://investors.biogen.com/news-releases/news-release-details/biogen-and-denali-therapeutics-provide-update-phase-2b-luma
Context: LUMA studied BIIB122 (DNL151), an LRRK2 inhibitor, in 648 early-stage Parkinson’s patients.
Key point: BIIB122 did not meet primary or secondary endpoints; Biogen and Denali will stop idiopathic Parkinson’s development.
Implication: May influence prescriber choice and payer reviews pending full data.
🌱 TFG-001 preclinical Parkinson’s cell therapy data [5] [France • 25 May 2026]
https://www.businesswire.com/news/home/20260524006397/en/TFG-001-A-Novel-3D-Neural-Microtissue-Cell-Therapy-Demonstrates-Superior-Functionality-and-Reinnervation-for-Parkinsons-Disease
Context: TreeFrog Therapeutics will present preclinical TFG-001 data at the 7th World Parkinson’s Conference.
Key point: TFG-001 showed rapid dopamine release and graft-derived reinnervation across translational Parkinson’s models.
Implication: Signals pipeline investment and modality expansion.
💊 CGRP migraine drugs lift California workers’ comp spend [6] [US • 20 May 2026]
https://www.businesswire.com/news/home/20260520809944/en/CWCI-Migraine-Drugs-Are-Now-the-Third-Most-Expensive-California-Workers-Comp-Drug
Context: CWCI analyzed California workers’ compensation prescription data through the first half of 2025.
Key point: Migraine drugs became the third-most expensive drug group, driven by higher-cost CGRP-targeted medicines.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
Why it Matters
- Long-acting CNS formulations remain a regulatory and adherence focus, with TEV-749 targeting a known schizophrenia treatment gap.
- na-SPMS activity is rising, with Tiziana now showing both Expanded Access trends and a fully enrolled placebo-controlled study.
- The BIIB122 LUMA miss narrows near-term idiopathic Parkinson’s LRRK2 development, while BEACON continues in pathogenic LRRK2 carriers.
- Parkinson’s cell therapy remains preclinical for TFG-001, but TreeFrog is positioning reinnervation and scalable manufacturing as differentiators.
- CGRP migraine drug uptake is becoming a cost-management issue in California workers’ compensation.
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FAQ
What is TEV-749 from Teva and Medincell?
TEV-749 is an investigational monthly subcutaneous olanzapine long-acting injectable for adult schizophrenia. EMA accepted its MAA, but it is not approved anywhere yet [1].
What did Tiziana report for intranasal foralumab in na-SPMS?
Tiziana reported tolerability and directional EDSS and MFIS trends in a 14-patient Expanded Access program. The company noted the small sample and trend-only nature of the analysis [2].
What is INFORM-MS?
INFORM-MS is Tiziana’s randomized, double-blind, placebo-controlled Phase 2a study of intranasal foralumab in na-SPMS. It enrolled 48 patients, with topline data expected in late Q3 2026 [3].
Why are Biogen and Denali stopping BIIB122 in idiopathic Parkinson’s disease?
BIIB122 did not slow disease progression versus placebo in Phase 2b LUMA, and secondary endpoints also did not show benefit. Denali will continue BEACON in pathogenic LRRK2 variant carriers [4].
What is TreeFrog’s TFG-001?
TFG-001 is a preclinical 3D neural microtissue cell therapy for Parkinson’s disease. TreeFrog reported rapid dopamine release and reinnervation signals in translational models [5].
Why did CWCI flag CGRP migraine drugs?
CWCI said migraine drugs now consume a larger share of California workers’ comp drug payments, despite remaining a small share of prescriptions. The increase is tied partly to higher-cost CGRP medicines [6].
Entities / Keywords
Teva Pharmaceutical Industries, Teva Pharmaceuticals International, Medincell, TEV-749, olanzapine LAI, SteadyTeq, schizophrenia
Tiziana Life Sciences, foralumab, intranasal foralumab, anti-CD3, na-SPMS, Expanded Access, INFORM-MS, NCT06292923
Biogen, Denali Therapeutics, BIIB122, DNL151, LUMA, BEACON, LRRK2, Parkinson’s disease
TreeFrog Therapeutics, TFG-001, 3D neural microtissue, iPSC-derived dopaminergic network, C-Stem, Parkinson’s disease
California Workers’ Compensation Institute, CWCI, migraine drugs, CGRP-targeted medicines, California workers’ compensation
References
- https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/The-European-Medicines-Agency-Accepts-Tevas-Marketing-Authorization-Application-for-Olanzapine-Long-Acting-Injectable-TEV-749-for-the-Treatment-of-Schizophrenia-in-Adults/default.aspx
- https://www.tizianalifesciences.com/tiziana-announces-new-positive-clinical-data-for-intranasal-foralumab-in-non-active-secondary-progressive-multiple-sclerosis/
- https://www.tizianalifesciences.com/tiziana-fully-enrolls-its-phase-2-placebo-controlled-multiple-sclerosis-trial/
- https://investors.biogen.com/news-releases/news-release-details/biogen-and-denali-therapeutics-provide-update-phase-2b-luma
- https://www.businesswire.com/news/home/20260524006397/en/TFG-001-A-Novel-3D-Neural-Microtissue-Cell-Therapy-Demonstrates-Superior-Functionality-and-Reinnervation-for-Parkinsons-Disease
- https://www.businesswire.com/news/home/20260520809944/en/CWCI-Migraine-Drugs-Are-Now-the-Third-Most-Expensive-California-Workers-Comp-Drug