This Neuroscience video recap highlights key developments across regulatory approvals, late-stage clinical milestones, CNS delivery technology advances, and trial initiations across neurology and psychiatry.
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- Week 7–13 January 2026
- Week 14–20 January 2026
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Top Stories Covered in This Video
Chapters
0:00 Introduction
0:09 Novartis licensed SciNeuro’s Alzheimer’s brain-shuttle antibody, $165M upfront, up to $1.7B total
0:31 Dyno launched Dyno-yp2, a TfR1-mediated AAV capsid with high CNS transduction and liver detargeting in humanized mice
1:05 Korea approved Chiesi’s velmanase alfa (Ramzede) for alpha-mannosidosis non-CNS symptoms
1:28 Kallyope set 2026 milestones, moving elismetrep toward registrational migraine studies and K-554 into Phase 1
1:59 Teva’s AJOVY pediatric Phase 3 (SPACE) NEJM publication showed significant efficacy in episodic migraine
2:38 J&J reported CAPLYTA adjunctive MDD remission benefits in pooled Phase 3 and 6-month extension data
3:24 Alto gained a new U.S. method-of-treatment patent protecting ALTO-207 into the mid-2040s
3:52 Axsome dosed first patient in FORWARD Phase 3 of AXS-14 (esreboxetine) for fibromyalgia
4:21 How to reach us
Transcript
Why it matters
- Brain-shuttle and capsid advances aim to unlock CNS delivery constraints, a gating factor in neurotherapeutics.
- Pediatric migraine data expand CGRP utility across ages, informing guidelines and access.
- New MDD remission analyses and precision approaches may shift adjunctive strategies.
- Rare disease approvals diversify global access to enzyme-replacement therapies.
- Late-stage fibromyalgia and migraine programs sustain momentum in pain and headache pipelines.
🗓️ Explore weekly details and sources
- Week 7–13 January 2026
- Week 14–20 January 2026
📚 View the full Neuroscience archive on our research hub page.
FAQ
What did Novartis license from SciNeuro, and for what indication? [1]
A worldwide license to an anti-amyloid antibody program that shuttles therapies across the BBB, aimed at Alzheimer’s disease. Deal terms include $165M upfront and up to $1.5B in milestones.
How does Dyno-yp2 compare with known comparators? [2]
In TfR1-humanized mice, Dyno-yp2 showed >94% neuronal transduction, ~11-fold higher brain biodistribution vs BI-hTFR1, and marked liver detargeting vs BI-hTFR1 and AAV9 under tested conditions.
What exactly did Korea approve for alpha-mannosidosis? [3]
MFDS approved Ramzede (velmanase alfa) for non-CNS symptoms, dose 10 mg, introduced by Kwangdong, representing the only approved therapy there for this disease.
What are Kallyope’s 2026 milestones? [4]
Initiate registrational elismetrep trials for acute migraine mid-2026 and start Phase 1 for K-554, with early safety/PK/PD readouts expected H2 2026 (details beyond scope not specified here).
What are the key SPACE trial outcomes for AJOVY? [5]
Over 12 weeks, −2.5 vs −1.4 monthly migraine days vs placebo (diff 1.1; p=0.02) and 47.2% vs 27.0% ≥50% responders, with a safety profile consistent with adults.
What remission data support CAPLYTA in MDD? [6]
Pooled Phase 3 showed higher 6-week remission (MADRS ≤10) vs placebo; in a 6-month extension, 65.4% reached remission, 44.1% complete remission, and 42.8% sustained remission as defined by the sponsor.
What protection does Alto’s new patent provide? [7]
U.S. Patent No. 12,521,374 covers treating depression with ALTO-207’s pramipexole-ondansetron approach, with protection expected into the mid-2040s per company statements.
What is the FORWARD trial design for AXS-14? [8]
Open-label induction followed by randomized withdrawal to AXS-14 8 mg vs placebo for up to 12 weeks. Primary endpoint is time to loss of therapeutic response.
Entities / Keywords
Novartis; SciNeuro; Alzheimer’s; brain-shuttle; BBB
Dyno Therapeutics; Dyno-yp2; AAV; TfR1; CNS delivery
Chiesi; Ramzede; velmanase alfa; alpha-mannosidosis; MFDS Korea
Kallyope; elismetrep; TRPM8; K-554; obesity; non-incretin
Teva; AJOVY; fremanezumab; SPACE; pediatric episodic migraine; NEJM
Johnson & Johnson; CAPLYTA; lumateperone; MDD; ACNP; MADRS remission
Alto Neuroscience; ALTO-207; pramipexole; ondansetron; patent
Axsome Therapeutics; AXS-14; esreboxetine; fibromyalgia; randomized-withdrawal
References
https://www.fiercebiotech.com/clinical-data/novartis-pays-scineuro-165m-ticket-another-shuttle-brain
https://biz.chosun.com/en/en-science/2026/01/12/KJY46LNFAVEOVAO6PNFVL3R2FY/?outputType=amp