This week’s Neuroscience update highlights advances in seizure therapeutics, migraine treatment, precision MS diagnostics, neuroinflammation targets, brain-tumor innovations, and early neurodegenerative pipeline progress.

In Today’s Newsletter

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🌏 Lundbeck presents new Bexicaserin data at AES Annual Meeting [1] [02 Dec 2025]

https://news.cision.com/h–lundbeck-a-s/r/lundbeck-to-present-comprehensive-new-bexicaserin-dataset-in-patients-with-rare-childhood-onset-epil,c4274529

Context: Lundbeck to present post-hoc analysis from the PACIFIC trial, showing early and sustained seizure reduction in DEE patients.

Key point: Bexicaserin demonstrates significant reduction in seizure frequency within 2 weeks, with effects lasting up to 1 year.

Implication: A potential first-in-class treatment for patients with drug-resistant childhood-onset epilepsies, pending further clinical trials.

💊 AbbVie’s Atogepant Phase 3 data shows pain freedom for acute migraine treatment [2] [01 Dec 2025]

https://news.abbvie.com/2025-12-01-AbbVie-to-Present-Phase-3-ECLIPSE-Data-Demonstrating-Atogepant-AQUIPTA-R-Superiority-Over-Placebo-in-Achieving-Pain-Freedom-for-the-Acute-Treatment-of-Migraine-at-the-19th-European-Headache-Congress

Context: Phase 3 ECLIPSE study shows atogepant’s superiority over placebo in pain freedom and most bothersome symptom relief for acute migraine attacks.

Key point: Atogepant achieved 24.3% pain freedom at 2 hours, significantly higher than placebo at 13.1%.

Implication: Atogepant may offer a new option for acute migraine relief, with EMA approval pending for broader use in Europe.

🧬 Octave Bioscience partners with Quest Diagnostics to expand access to MSDA Test [3] [01 Dec 2025]

https://www.businesswire.com/news/home/20251201400583/en/Octave-Bioscience-Forms-Strategic-Collaboration-with-Quest-Diagnostics-to-Expand-Patient-Access-to-the-Octave-Multiple-Sclerosis-Disease-Activity-MSDA-Test-Across-the-United-States

Context: Octave Bioscience and Quest Diagnostics collaborate to provide expanded access to the Multiple Sclerosis Disease Activity (MSDA) Test via Quest’s network.

Key point: MSDA Test, a multi-analyte blood test, helps clinicians assess disease activity in MS patients, reducing reliance on MRI alone.

Implication: Wider access to precision MS care through Quest’s 7,000 U.S. service centers, enhancing patient monitoring and treatment decisions.

🧠 Lynk Pharmaceuticals receives FDA IND approval for LNK01006 [4] [02 Dec 2025]

https://www.manilatimes.net/2025/12/02/tmt-newswire/pr-newswire/lynk-pharmaceuticals-announces-fda-ind-approval-of-its-allosteric-tyk2-inhibitor-lnk01006/2234807

Context: FDA grants approval for clinical trials of LNK01006, a TYK2 allosteric inhibitor designed to treat neuroinflammatory diseases like multiple sclerosis.

Key point: LNK01006 has high brain penetration and promising preclinical efficacy in treating CNS inflammation.

Implication: Potential for a new treatment option in neuroinflammatory conditions, with the IND approval paving the way for human trials.

🎯 NeOnc Technologies’ NEO100 enhanced by ultrasound in brain tumor treatment [5] [01 Dec 2025]

https://www.manilatimes.net/2025/12/01/tmt-newswire/globenewswire/neonc-technologies-nasdaq-nthi-announces-ai-driven-findings-showing-ultrasound-enhances-the-potency-of-an-already-effective-neo100-in-treating-primary-and-metastatic-brain-tumors/2234447

Context: AI-driven studies show that ultrasound enhances the potency of NEO100, an agent for brain tumors.

Key point: NEO100 combined with ultrasound significantly improves tumor-killing activity in various brain tumor types.

Implication: This novel combination could revolutionize brain tumor treatment with non-invasive, targeted therapy.

☢️ Sound Pharmaceuticals granted FDA breakthrough therapy designation for SPI-1005 [6] [01 Dec 2025]

https://www.pharmiweb.com/press-release/2025-12-01/sound-pharmaceuticals-receives-fda-breakthrough-therapy-designation-for-spi-1005-to-treat-meniere-s

Context: SPI-1005, an oral anti-inflammatory drug, receives breakthrough therapy designation for Meniere’s disease, a condition with no FDA-approved treatments.

Key point: SPI-1005 shows improvement in hearing loss and tinnitus in Phase 3 trials, offering a potential new treatment option.

Implication: Potential for faster FDA approval, addressing a significant unmet need for Meniere’s disease patients.

🧩 GEN Pharmaceuticals reports positive Phase 1 data for SUL-238 [7] [02 Dec 2025]

https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/gen-announces-new-positive-phase-1-trial-data-of-the-investigational-1113050

Context: GEN’s novel mitochondrial-targeted drug, SUL-238, demonstrates excellent safety and pharmacokinetics in Phase 1 trials for neurodegenerative diseases.

Key point: The drug shows high cerebrospinal fluid penetration, making it a promising candidate for Alzheimer’s and Parkinson’s diseases.

Implication: SUL-238’s favorable profile could advance clinical development in Alzheimer’s and other neurodegenerative conditions.

Why it Matters

  • Bexicaserin’s data at AES [1] adds a promising treatment option for DEEs, a rare and difficult-to-treat group of childhood-onset epilepsies, with potential long-term impact on patient care.
  • AbbVie’s Atogepant [2] could become a key acute migraine treatment, offering better pain relief compared to current options, especially for those with unmet needs.
  • Octave Bioscience [3] and Quest Diagnostics’ partnership brings precision MS testing to the forefront, improving personalized care for patients.
  • Lynk Pharmaceuticals [4] could open new doors for brain-penetrant therapies targeting neuroinflammatory diseases, with LNK01006 offering promising preclinical results.
  • NeOnc Technologies [5] is advancing innovative non-invasive tumor treatments, with ultrasound-enhanced therapies showing significant promise for brain tumor care.
  • Sound Pharmaceuticals [6] tackles Meniere’s disease, a disorder with few treatment options, bringing a potential breakthrough to improve quality of life for patients.
  • GEN Pharmaceuticals [7] is making strides in neurodegenerative disease research, with SUL-238 showing significant promise for future Alzheimer’s and Parkinson’s treatments.

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FAQ

What is the significance of Bexicaserin’s presentation at AES?

Bexicaserin’s Phase 1b/2a trial data, showing early and sustained seizure reduction, presents a new treatment avenue for patients with drug-resistant DEEs, a group with limited options. The data at AES is expected to advance its clinical development [1].

How does Atogepant differ from current migraine treatments?

Atogepant showed superior pain freedom at 2 hours post-treatment compared to placebo in the Phase 3 ECLIPSE study, making it a promising new option for acute migraine relief [2].

How does the Octave MSDA test work?

The MSDA test offers a multi-analyte blood analysis, providing clinicians with valuable data to assess MS disease activity, enabling better-informed treatment decisions [3].

What does FDA approval of LNK01006 mean?

LNK01006’s approval for clinical trials signals the start of exploring a new class of TYK2 inhibitors aimed at treating neuroinflammatory conditions, particularly diseases like multiple sclerosis [4].

How does ultrasound enhance NEO100’s effect on brain tumors?

Combining ultrasound with NEO100 amplifies its tumor-killing activity in a variety of brain tumors, opening up a non-invasive treatment approach for brain cancer patients [5].

What does breakthrough therapy designation for SPI-1005 mean?

FDA’s Breakthrough Therapy Designation accelerates the development of SPI-1005, offering a potential new treatment for Meniere’s disease, especially in addressing hearing loss and tinnitus, where there are currently no approved therapies [6].

What did Phase 1 data reveal about SUL-238?

SUL-238 showed excellent safety, favorable pharmacokinetics, and high CSF penetration, positioning it as a promising candidate for treating Alzheimer’s and other neurodegenerative diseases [7].

Entities / Keywords

Bexicaserin, DEEs, Lundbeck, PACIFIC Trial.
Atogepant, AbbVie, ECLIPSE study, acute migraine.
MSDA Test, Octave Bioscience, Quest Diagnostics.
LNK01006, Lynk Pharmaceuticals, TYK2 inhibitor.
NEO100, NeOnc Technologies, ultrasound, brain tumors.
SPI-1005, Sound Pharmaceuticals, Meniere’s disease.
SUL-238, GEN Pharmaceuticals, Alzheimer’s, Parkinson’s.

References

  1. https://news.cision.com/h–lundbeck-a-s/r/lundbeck-to-present-comprehensive-new-bexicaserin-dataset-in-patients-with-rare-childhood-onset-epil,c4274529
  2. https://news.abbvie.com/2025-12-01-AbbVie-to-Present-Phase-3-ECLIPSE-Data-Demonstrating-Atogepant-AQUIPTA-R-Superiority-Over-Placebo-in-Achieving-Pain-Freedom-for-the-Acute-Treatment-of-Migraine-at-the-19th-European-Headache-Congress
  3. https://www.businesswire.com/news/home/20251201400583/en/Octave-Bioscience-Forms-Strategic-Collaboration-with-Quest-Diagnostics-to-Expand-Patient-Access-to-the-Octave-Multiple-Sclerosis-Disease-Activity-MSDA-Test-Across-the-United-States
  4. https://www.manilatimes.net/2025/12/02/tmt-newswire/pr-newswire/lynk-pharmaceuticals-announces-fda-ind-approval-of-its-allosteric-tyk2-inhibitor-lnk01006/2234807
  5. https://www.manilatimes.net/2025/12/01/tmt-newswire/globenewswire/neonc-technologies-nasdaq-nthi-announces-ai-driven-findings-showing-ultrasound-enhances-the-potency-of-an-already-effective-neo100-in-treating-primary-and-metastatic-brain-tumors/2234447
  6. https://www.pharmiweb.com/press-release/2025-12-01/sound-pharmaceuticals-receives-fda-breakthrough-therapy-designation-for-spi-1005-to-treat-meniere-s
  7. https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/gen-announces-new-positive-phase-1-trial-data-of-the-investigational-1113050

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