This week’s Neuroscience update features major regulatory decisions, strong mid- and late-stage clinical data, strategic industry partnerships, and expanded patient access initiatives. These developments underscore rapid momentum across therapeutics, trials, and health-system policy.
In Today’s Newsletter
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🌍 Johnson & Johnson’s IMAAVY® gets European approval [1]
Context: European Commission approves IMAAVY® for treating generalized myasthenia gravis (gMG) in adults and adolescents aged 12 and older.
Key Point: Nipocalimab offers sustained disease control for up to 20 months, showing significant reduction in IgG levels in pivotal trials.
Implication: A major advancement in treating gMG, particularly for those who are anti-AChR or anti-MuSK antibody-positive.
💊 Bristol Myers Squibb continues ADEPT-2 study in Alzheimer’s psychosis [2]
Context: ADEPT-2 Phase 3 trial continues after reviewing irregularities at some clinical sites, enrolling additional patients.
Key Point: The study aims to evaluate Cobenfy, a treatment for Alzheimer’s-related psychosis.
Implication: Despite setbacks, this study could offer new hope for a condition with few treatment options.
🔬 Eli Lilly and Indiana University form $40M partnership [3]
Context: $40 million collaboration to enhance clinical trial infrastructure and Alzheimer’s disease research in Indiana.
Key Point: The partnership will improve access to clinical trials and foster talent in Indiana’s growing life sciences sector.
Implication: Strengthens Indiana as a leader in clinical research and accelerates drug development, especially for Alzheimer’s.
⚡ Kallyope’s Elismetrep shows promise in migraine treatment [4]
Context: Kallyope’s Elismetrep shows positive Phase 2b results for acute migraine relief, with no safety concerns.
Key Point: Elismetrep demonstrated significant efficacy in relieving migraine pain, positioning it as a new treatment option.
Implication: A new class of migraine treatments could be on the horizon, with registrational studies set for mid-2026.
🧠 Lundbeck’s Bexicaserin data supports long-term seizure control [5]
Context: Long-term data shows Bexicaserin maintains significant seizure reduction in patients with rare childhood-onset epilepsies.
Key Point: Seizure frequency reduced by up to 60% at 24 months, with promising safety and tolerability.
Implication: Bexicaserin could become a first-in-class treatment for drug-resistant childhood-onset epilepsies.
🔬 Praxis halts relutrigine study early due to strong results [6]
Context: Praxis halts Phase II epilepsy trial early following recommendations from the data monitoring board.
Key Point: Strong results in relutrigine for patients with developmental epileptic encephalopathies (DEE) and SCN mutations.
Implication: Pre-NDA meeting with the FDA signals fast-tracking for approval.
🇦🇺 Australia’s PBS adds cheaper MS, cancer drugs [7]
Context: Australia adds Ocrelizumab, Toripalimab, Bimekizumab, and Pegcetacoplan to the Pharmaceutical Benefits Scheme (PBS).
Key Point: These treatments will be available at reduced costs, expanding access to life-saving drugs for multiple sclerosis and cancer patients.
Implication: This initiative ensures broader access to essential treatments across the country, easing the financial burden on patients.
Why It Matters
- Johnson & Johnson’s IMAAVY® approval [1] provides a long-awaited solution for gMG patients, offering sustained relief with fewer side effects.
- Bristol Myers Squibb’s ADEPT-2 study [2] could lead to breakthrough treatments for Alzheimer’s-related psychosis, a condition with few current options.
- Eli Lilly and IU’s partnership [3] represents a bold step forward in developing a cutting-edge clinical trial ecosystem and fostering Alzheimer’s research in Indiana.
- Kallyope’s Elismetrep [4] could be a game-changer for acute migraine sufferers, targeting a novel mechanism for effective relief.
- Lundbeck’s Bexicaserin [5] shows lasting seizure control in childhood-onset epilepsies, offering hope for those with few treatment options.
- Praxis Precision Medicines [6] brings a promising new drug for epilepsy to the FDA, highlighting the potential of relutrigine in DEE.
- Australia’s PBS listings [7] improve access to vital treatments for multiple sclerosis and rare cancers, ensuring more equitable healthcare.
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FAQ
What does the approval of IMAAVY® mean for gMG patients?
IMAAVY® offers long-term disease control for patients with generalized myasthenia gravis, especially those who are anti-AChR or anti-MuSK antibody-positive. This new treatment can significantly improve quality of life by reducing symptoms for up to 20 months [1].
Why is the ADEPT-2 study important?
The ADEPT-2 study could bring a novel treatment for psychosis in Alzheimer’s patients, a condition currently lacking FDA-approved therapies. Despite some trial site irregularities, the continued study offers hope for future breakthroughs [2].
How does Kallyope’s Elismetrep differ from other migraine treatments?
Elismetrep targets the TRPM8 receptor, offering a new mechanism for relieving migraine pain. It shows competitive efficacy compared to existing treatments and could provide a much-needed solution for those who don’t respond well to current therapies [4].
What are the implications of the PBS listing in Australia?
The new PBS listings ensure Australians have access to more affordable medications for multiple sclerosis and rare cancers, reducing the financial burden and improving access to critical treatments [7].
Entities / Keywords
IMAAVY®, nipocalimab, generalized myasthenia gravis, Johnson & Johnson
ADEPT-2, Cobenfy, Alzheimer’s psychosis, Bristol Myers Squibb
Eli Lilly, Indiana University, clinical trials, Alzheimer’s disease
Elismetrep, migraine, Kallyope
Bexicaserin, childhood-onset epilepsies, Lundbeck
Relutrigine, epilepsy, Praxis Precision Medicines
PBS, Ocrelizumab, Toripalimab, Bimekizumab, Pegcetacoplan, Australia
References
- https://www.jnj.com/media-center/press-releases/johnson-johnson-receives-european-commission-approval-of-imaavy-nipocalimab-a-new-fcrn-blocker-offering-sustained-disease-control-in-a-broad-population-of-people-living-with-generalised-myasthenia-gravis-gmg
- https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Announces-Continuation-of-ADEPT-2-Phase-3-Study-in-Psychosis-Associated-with-Alzheimers-Disease/default.aspx
- https://investor.lilly.com/news-releases/news-release-details/lilly-and-iu-expand-access-clinical-trials-and-latest-innovative
- https://www.businesswire.com/news/home/20251208947827/en/Kallyope-Announces-Positive-Results-from-Phase-2b-Study-of-Elismetrep-for-the-Acute-Treatment-of-Migraine
- https://www.biospace.com/drug-development/lundbeck-announces-positive-phase-2-long-term-data-for-bexicaserin-in-rare-childhood-onset-epilepsie,c4274545
- https://www.biospace.com/drug-development/praxis-ends-epilepsy-study-early-due-to-strong-results-heads-to-fda
- https://www.health.gov.au/ministers/the-hon-mark-butler-mp/media/cheaper-multiple-sclerosis-and-rare-cancer-medicines-now-on-pbs