This biweekly Neuroscience video recap highlights key regulatory filings, Phase 3 readouts, early-stage dosing milestones, and strategic pipeline shifts across neurology and psychiatry.
🎯 Watch Our Video Summary Capturing Neuroscience News from the Last Two Weeks
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- Week 18–24 February 2026
- Week 25 February–3 March 2026
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Top Stories Covered in This Video
Chapters
0:00 Inrtoduction
0:08 Tirabrutinib NDA accepted for R/R PCNSL
0:41 Teva–Medincell TEV-’749 NDA accepted for once-monthly schizophrenia treatment
1:14 Ionis stops ION269 Down syndrome Alzheimer’s program
1:39 Axsome doses first patient in CLARITY Phase 3 (solriamfetol in MDD with EDS)
2:05 IRLAB doses first patient in LIFT-PD Phase Ib (IRL757 for Parkinson’s apathy)
2:31 GEMMABio doses first patient in CHARISMA Phase 1/2 (GB221 for SMA1)
2:56 uniQure gets FDA feedback on AMT-130 path, randomized sham-controlled study recommended
3:27 Roche reports positive Phase 3 FENhance 1 for fenebrutinib in relapsing MS
3:51 How to reach us
Transcript
Welcome to the latest edition of Neuroscience Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.
The FDA accepted the new drug application for tirabrutinib under the accelerated approval pathway for relapsed or refractory primary CNS lymphoma. The submission is supported by the Phase 2 PROSPECT study, with a confirmatory global Phase 3 trial currently recruiting. A PDUFA action date has been set according to the source, positioning tirabrutinib as a potential new option in this high-need oncology setting pending regulatory review.
The FDA also accepted the NDA from Teva and Medincell for TEV-’749, an investigational once-monthly subcutaneous long-acting injectable formulation of olanzapine for adults with schizophrenia. The application references data from the Phase 3 SOLARIS program, including results through Week 56. If approved, TEV-’749 could expand long-acting treatment options aimed at supporting adherence in schizophrenia management.
Ionis announced it has terminated the Phase 1 study of ION269 for Alzheimer’s disease in people with Down syndrome. The company cited slow enrollment as the reason for discontinuation and stated the decision was not related to safety concerns with the investigational therapy, signaling a shift in pipeline prioritization.
Axsome Therapeutics reported dosing the first patient in the Phase 3 CLARITY trial evaluating solriamfetol for major depressive disorder with excessive daytime sleepiness. The study includes an open-label treatment period followed by a randomized, double-blind withdrawal phase, with time to relapse of depressive symptoms after randomization as the primary endpoint.
IRLAB Therapeutics dosed the first patient in its Phase Ib LIFT-PD study of IRL757 for Parkinson’s disease-related apathy. The trial is designed to assess safety, tolerability, and exploratory signals across multiple European countries, and the milestone triggered a payment under IRLAB’s collaboration with MSRD, an Otsuka affiliate.
GEMMABio announced the first patient has been dosed in the Phase 1/2 CHARISMA trial of GB221, an investigational next-generation gene therapy for spinal muscular atrophy type 1. The study is evaluating intrathecal delivery in infants, and the company noted that GB221 has received FDA rare pediatric disease designation.
uniQure provided an update on its regulatory interactions with the FDA regarding AMT-130 for Huntington’s disease. Following a Type A meeting, the agency stated it could not agree that Phase I/II data compared with an external control would be sufficient as primary evidence of effectiveness for a marketing application, and strongly recommended a prospective, randomized, double-blind, sham surgery-controlled study.
Roche reported that its Phase 3 FENhance 1 trial of fenebrutinib in relapsing multiple sclerosis met its primary endpoint versus teriflunomide. The company stated it plans to submit the totality of its Phase 3 multiple sclerosis program data to regulators, with additional details to be shared at a future scientific meeting.
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- Two FDA NDA acceptances (tirabrutinib, TEV-’749) signal near-term regulatory decision timelines and potential category shifts in oncology and psychiatry. [1], [2]
- Multiple “first patient dosed” milestones (Axsome, IRLAB, GEMMABio) de-risk operational execution, but clinical readouts remain ahead. [4]–[6]
- FDA’s feedback to uniQure highlights the evidentiary bar for neurosurgical gene therapy programs when relying on external controls. [7]
- Roche’s Phase 3 result strengthens the BTK inhibitor narrative in MS, while emphasizing the need to scrutinize full safety and outcomes disclosures when presented. [8]
🗓️ Explore weekly details and sources
- Week 18–24 February 2026
- Week 25 February–3 March 2026
📚 View the full Neuroscience archive on our research hub page.
FAQ
What is tirabrutinib being reviewed for in the US, and under what pathway?
Tirabrutinib is under FDA review for relapsed or refractory primary CNS lymphoma, using the accelerated approval pathway per the source. [1]
What is TEV-’749, and what is Teva asking FDA to approve?
TEV-’749 is an investigational once-monthly, subcutaneous long-acting olanzapine formulation, submitted for treatment of schizophrenia in adults. [2]
Why did Ionis stop ION269 for Alzheimer’s disease in people with Down syndrome?
Ionis said the Phase 1 study was terminated due to slow enrollment and stated the decision was not related to concerns with the study drug. [3]
How is Axsome’s CLARITY Phase 3 trial designed?
CLARITY uses an open-label solriamfetol period followed by a randomized, double-blind withdrawal phase, with a primary endpoint of time to relapse of depressive symptoms after randomization. [4]
What did FDA tell uniQure about AMT-130’s evidence package?
FDA said it could not agree that Phase I/II data compared to an external control are sufficient as primary evidence for a marketing application, and recommended a randomized, double-blind, sham-controlled study. [7]
What did Roche report for fenebrutinib in relapsing MS?
Roche reported FENhance 1 met its primary endpoint versus teriflunomide and said it will submit the Phase 3 program’s data to regulators, with additional details to be shared at a future meeting per the release. [8]
Entities / Keywords
Tirabrutinib (ONO-4059, Velexbru), Ono Pharmaceutical, Deciphera, primary CNS lymphoma (PCNSL), BTK inhibitor, PROSPECT (NCT04947319) [1]
TEV-’749, Teva, Medincell, SteadyTeq, olanzapine LAI, SOLARIS Phase 3, schizophrenia [2]
Ionis Pharmaceuticals, ION269, Down syndrome, Alzheimer’s disease [3]
Axsome Therapeutics, solriamfetol, CLARITY Phase 3, MDD, excessive daytime sleepiness (EDS) [4]
IRLAB Therapeutics, IRL757, LIFT-PD Phase Ib, Parkinson’s disease apathy, MSRD, Otsuka [5]
GEMMABio (GEMMA Biotherapeutics), GB221, CHARISMA (NCT07070999), SMA1, SMN1 gene therapy, rare pediatric disease designation [6]
uniQure, AMT-130, Huntington’s disease, Type A meeting, sham-controlled study [7]
Roche, fenebrutinib, FENhance 1, FENhance 2, FENtrepid, RMS, PPMS, teriflunomide, BTK inhibitor [8]
