Neuroscience Today—January 21, 2026

LucidQuest

5 days ago

This edition spans clinical data in neurology and psychiatry, digital health feature rollouts, IP actions, and R&D collaborations. Highlights include late-stage trials, observational analytics, and pharmacologic head-to-heads.

In Today’s Newsletter

Dive deeper

🧒 AJOVY pediatric episodic migraine data in NEJM [1] [14 Jan 2026]

https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/AJOVY-fremanezumab-vfrm-Significantly-Reduced-Monthly-Migraine-and-Headache-Days-in-Children-and-Adolescents-with-Episodic-Migraine-Compared-to-Placebo-in-the-SPACE-Trial-Results-Published-in-New-England-Journal-of-Medicine/default.aspx
Context: SPACE, 3-month randomized placebo-controlled study in 237 patients aged 6–17 with episodic migraine.
Key point: AJOVY cut monthly migraine and headache days vs placebo over 12 weeks and increased ≥50% responders. FDA approved in Aug 2025 for 6–17 years weighing ≥45 kg.
Implication: May influence prescriber choice and payer reviews pending full data.

💍 Ultrahuman + Click Therapeutics “Migraine PowerPlug” for Ring Air [2] [15 Jan 2026]

https://www.wareable.com/health-and-wellbeing/ultrahuman-migraine-tracking-powerplug-prevention-prediction
Context: Software feature uses HRV, sleep, movement, stress to flag triggers; integrates FDA-authorized digital therapeutics from Click.
Key point: Pilot followed by early-2026 rollout across major markets; provides tailored behavioral guidance to reduce attack risk.
Implication: DTC/telehealth: Could streamline initiation and adherence via remote prescribing and logistics.

😊 CAPLYTA adjunctive in MDD shows higher remission in pooled Phase 3 [3] [16 Jan 2026]

https://www.jnj.com/media-center/press-releases/new-clinical-data-highlights-caplyta-lumateperone-as-a-promising-option-for-achieving-remission-in-adults-with-major-depressive-disorder
Context: Pooled Studies 501/502 at 6 weeks and 6-month open-label Study 503.
Key point: Adjunctive CAPLYTA nearly doubled remission vs placebo at 6 weeks; open-label showed sustained and complete remission rates over 24 weeks.
Implication: May influence prescriber choice and payer reviews pending full data.

🧠 ML predicts early PIRA in multiple sclerosis [4] [16 Jan 2026]

https://multiplesclerosisnewstoday.com/news-posts/2026/01/16/machine-learning-predict-pira-first-years-ms-diagnosis/
Context: European Journal of Neurology study, 719 patients, first 3 years post-onset; observational analysis.
Key point: Random Forest achieved AUC ~0.75 overall, up to 0.8 in selected subsets using routine clinical variables; MRI added limited value.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧬 INGREZZA shows higher VMAT2 occupancy vs AUSTEDO XR (PET) [5] [15 Jan 2026]

https://neurocrine.gcs-web.com/news-releases/news-release-details/neurocrine-biosciences-presents-head-head-ingrezzar-valbenazine
Context: Single-dose PET in 8 participants; therapeutic doses of valbenazine and deutetrabenazine.
Key point: Least-squares mean occupancy ~76.5% for INGREZZA vs ~38.3% for AUSTEDO XR; modeling suggested higher steady-state engagement with INGREZZA.
Implication: May influence prescriber choice and payer reviews pending full data.

🤝 IRLAB–Biomia collaboration on CNS discovery via ISP [6] [19 Jan 2026]

https://irlab.se/mfn_news/irlab-enters-collaboration-agreement-with-danish-biotech-company-biomia-aps-applying-the-integrative-screening-process-isp/
Context: IRLAB’s ML/AI-supported Integrative Screening Process to phenotype and evaluate Biomia’s compounds across undisclosed CNS indications.
Key point: Biomia supplies compounds and funds studies; ISP to aid target indication prediction and differentiation vs current treatments.
Implication: Signals pipeline investment and modality expansion.

🧾 Patent issued for ALTO-207 in depression [7] [14 Jan 2026]

https://www.businesswire.com/news/home/20260114749833/en/Alto-Neuroscience-Strengthens-Intellectual-Property-Portfolio-with-Issuance-of-New-Method-of-Treatment-Patent-for-ALTO-207-in-Depression
Context: U.S. Patent No. 12,521,374 covers treating depression with pramipexole + ondansetron to enable higher pramipexole dosing.
Key point: Issued and pending claims expected to protect ALTO-207 into the mid-2040s.
Implication: Introduces competition that may affect pricing and formulary access.

🧩 Axsome starts FORWARD Phase 3 of AXS-14 in fibromyalgia [8] [15 Jan 2026]

https://www.globenewswire.com/news-release/2026/01/15/3219394/0/en/Axsome-Therapeutics-Initiates-FORWARD-Phase-3-Trial-of-AXS-14-for-the-Management-of-Fibromyalgia.html
Context: Randomized-withdrawal design after 12-week open-label response; once-daily 8 mg esreboxetine vs placebo.
Key point: First patient dosed; primary endpoint is time from randomization to loss of therapeutic response.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

Pediatric migraine prevention options are expanding, with CGRP antagonists now reaching younger cohorts [1].
Wearables are moving from tracking to prediction and guided intervention in migraine management [2].
Adjunctive antipsychotic mechanisms are being positioned for remission, not just response, in MDD [3].
Early PIRA prediction could shift MS treatment intensity and monitoring in the first 3 years [4].
VMAT2 occupancy data may shape TD and HD chorea choice between valbenazine and deutetrabenazine [5].

FAQ

What did the AJOVY pediatric study actually show?

NEJM-published SPACE data reported reductions in monthly migraine and headache days vs placebo over 12 weeks in 6–17-year-olds, with higher ≥50% responder rates. FDA cleared pediatric use for ≥45 kg in Aug 2025 [1].

Is CAPLYTA now approved for MDD adjunctive therapy?

Yes. FDA approval was in Nov 2025 for adjunctive MDD. New analyses show higher 6-week remission vs placebo and durability in a 6-month open-label extension, though open-label limits causal inference [3].

How strong is the MS PIRA prediction model?

In routine clinical data, a Random Forest achieved AUC ~0.75 overall and up to 0.8 in subsets, suggesting moderate discrimination. It is observational and needs external validation [4].

Does higher VMAT2 occupancy mean better clinical outcomes?

Occupancy is a pharmacologic marker thought to relate to response in TD and HD chorea. Neurocrine’s PET study showed higher occupancy for INGREZZA vs AUSTEDO XR after single doses, but clinical benefit comparisons were not tested here [5].

What protection does Alto’s new patent provide for ALTO-207?

A U.S. method-of-treatment patent covering pramipexole + ondansetron in depression, with issued and pending claims expected to extend into the mid-2040s, supporting long-term exclusivity if upheld [7].

What is the FORWARD design for AXS-14?

Open-label esreboxetine for 12 weeks to identify responders, then randomized withdrawal to AXS-14 vs placebo. Primary endpoint is time to loss of therapeutic response [8].

Entities / Keywords

AJOVY, fremanezumab-vfrm, CGRP; Ultrahuman Ring Air, Click Therapeutics, digital therapeutics; CAPLYTA, lumateperone, MDD; PIRA, multiple sclerosis, Random Forest; INGREZZA, valbenazine, AUSTEDO XR, deutetrabenazine, VMAT2 occupancy; IRLAB, Biomia, Integrative Screening Process; Alto Neuroscience, ALTO-207, pramipexole, ondansetron; Axsome, AXS-14, esreboxetine, fibromyalgia.