Neuroscience Video Recap—January 7, 2026

First, the UK’s NICE recommends natalizumab for adults with highly active relapsing remitting multiple sclerosis after at least one disease-modifying therapy when cladribine is unsuitable. This covers Tysabri as a subcutaneous originator and Tyruko as an intravenous biosimilar, adding a pregnancy-suitable option, broadening choice, and likely increasing competition that could affect pricing and formulary access.

Next, Sandoz launches Tyruko in the United States, the first and only multiple sclerosis biosimilar to Tysabri for all reference indications. A Risk Evaluation and Mitigation Strategy is in place, with Labcorp support for JC virus antibody testing, positioning Tyruko as a cost-effective, clinically equivalent alternative that may influence payer decisions.

Third, the FDA has issued a Complete Response Letter for Sanofi’s tolebrutinib in non-relapsing secondary progressive multiple sclerosis. Reviews in Europe and other regions continue, and an expanded access protocol was submitted at the FDA’s request. Sanofi highlights the unmet need in slowing disability progression and plans to work with the agency on next steps.

Fourth, long-term data for QALSODY, tofersen, in SOD1 amyotrophic lateral sclerosis are published in JAMA Neurology, covering the Phase 3 VALOR study and its open-label extension with more than three and a half years of follow-up. Earlier initiation is associated with numerically slower clinical decline, reduced risk of death or permanent ventilation, and sustained reductions in neurofilament, which may shape prescribing and payer assessments.

Fifth, Biohaven reports that BHV-7000, a Kv7.2 and Kv7.3 channel activator, did not show benefit versus placebo on the Montgomery-Åsberg Depression Rating Scale in a roughly 300-patient, six-week Phase 2 major depressive disorder trial. The company is deprioritizing psychiatry while continuing its epilepsy program, with readouts ahead.

Sixth, the FDA has accepted and granted Priority Review to the supplemental new drug application for Axsome’s AXS-05 for agitation associated with Alzheimer’s disease. The submission includes four randomized, controlled Phase 3 trials and a long-term safety study, with a PDUFA action goal set.

Seventh, a Nature study using the Quanterix Simoa plasma pTau-217 assay analyzed more than eleven thousand four hundred samples from Norway’s HUNT study. The assay maps age-linked Alzheimer’s disease pathology at a population level and helps rule out Alzheimer’s in specific subsets, informing treatment eligibility and clinical trial enrollment, while interpretation depends on study design and confounding control.

Eighth, IRLAB has approval to begin a Phase Ib, signal-finding study of IRL757 for apathy in Parkinson’s disease, enrolling seventy-five patients at sixteen European sites. Prior Phase 1 studies in young and older adults showed good exposure and tolerability over ten days with no serious adverse events, and the trial is funded by MSRD, an Otsuka subsidiary. Stay ahead in Neuroscience research! Like, share, and subscribe for our updates. Visit www.lqventures.com
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