This weekly update in neuroscience highlights key regulatory actions, clinical progress, and partnerships within the field. It includes major approvals, data releases, and developments that could impact patient care and treatment options.

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🧠 UPLIZNA® Approved for Generalized Myasthenia Gravis in Europe [1] [12 Feb 2026]

https://investors.amgen.com/news-releases/news-release-details/european-commission-approves-amgens-upliznar-generalized
Context: Supported by the Myasthenia Gravis Inebilizumab Trial (MINT), the approval offers a twice-yearly maintenance dosing regimen with promising efficacy and a reduction in steroid use.
Key point: The European Commission approved UPLIZNA® (inebilizumab) as an add-on treatment for adults with anti-AChR+ and anti-MuSK+ generalized myasthenia gravis (gMG).
Implication: This approval introduces a new, targeted option for gMG treatment in Europe, with potential impacts on prescriber choices and reimbursement policies.

😴 Lundbeck’s Bocunebart Shows Promise for Migraine Prevention [2] [12 Feb 2026]

https://news.cision.com/h–lundbeck-a-s/r/lundbeck-announces-positive-phase-iib-top-line-results-with-bocunebart–lu-ag09222–anti-pacap-mab–,c4307114
Context: Bocunebart demonstrated significant reductions in monthly migraine days, particularly in patients with prior treatment failures. Safety was comparable to placebo.
Key point: bocunebart (Lu AG09222), an anti-PACAP monoclonal antibody, met its primary endpoint in the Phase IIb PROCEED trial for migraine prevention.
Implication: The positive results may guide regulatory filings and open new treatment options for patients with severe, treatment-resistant migraines.

💰 Immunic Raises $400 Million to Transition to Commercial Stage [3] [13 Feb 2026]

https://www.prnewswire.com/news-releases/immunic-announces-oversubscribed-private-placement-of-up-to-usd-400-million-to-accelerate-transformation-into-commercial-stage-company-302687546.html
Context: The funds will support ongoing Phase 3 trials for vidofludimus calcium in multiple sclerosis and preparations for commercialization.
Key point: Immunic completed an oversubscribed private placement for up to $400 million to fund its transition from R&D to a commercial-stage entity.
Implication: The financing marks a critical step in Immunic’s growth, positioning the company to advance its pipeline, particularly in MS.

🧬 Oncotelic Expands IP for OT-101 in CNS Applications [4] [12 Feb 2026]

https://www.globenewswire.com/news-release/2026/02/12/3237197/0/en/Oncotelic-Therapeutics-Inc-and-Sapu-Bioscience-Expand-International-IP-Coverage-for-OT-101-Strengthening-CNS-and-Neurology-Commercialization-Pathway.html
Context: OT-101, a TGF-β antisense inhibitor, has demonstrated clinical efficacy in oncology and is being further developed for CNS disorders.
Key point: Oncotelic and Sapu Bioscience expanded OT-101’s intellectual property, adding new claims for treating Parkinson’s Disease and delivering the therapy via intracranial infusion.
Implication: The expanded IP strengthens OT-101’s commercial potential in neurology, enhancing opportunities for partnerships and future clinical development.

🧠 Denovo Biopharma Partners with Orygen on Psychosis Study [5] [11 Feb 2026]

https://www.manilatimes.net/2026/02/11/tmt-newswire/globenewswire/denovo-biopharma-announces-partnership-with-orygen-on-phase-2-study-evaluating-db103-pomaglumetad-methionil-in-treating-psychosis/2276204
Context: This open-label study will investigate DB103’s efficacy and safety in young patients, targeting glutamate system dysfunction, a key factor in psychosis.
Key point: Denovo Biopharma has partnered with Orygen to initiate a Phase 2 study of DB103 (pomaglumetad methionil) in first-episode psychosis and clinical high-risk psychosis.
Implication: This collaboration could provide valuable data for the development of novel treatments for psychosis, a condition with limited effective therapies for young patients.

🧬 Soin Neuroscience & Lilac Biosciences Collaborate on Pain Research [6] [13 Feb 2026]

https://www.prnewswire.com/news-releases/soin-neuroscience-and-lilac-biosciences-launch-collaboration-to-study-rna-signatures-in-pain-and-neuromodulation-302687703.html
Context: The collaboration will focus on using RNA profiling to identify biological markers for pain and treatment response, advancing neuromodulation technology.
Key point: Soin Neuroscience and Lilac Biosciences have launched a research collaboration to explore RNA signatures in pain and neuromodulation.
Implication: This research could lead to more objective biomarkers for pain, enhancing the development of targeted neuromodulation therapies.

💊 Alto Neuroscience Completes Phase 2 Enrollment for ALTO-101 in Schizophrenia [7] [13 Feb 2026]

https://investors.altoneuroscience.com/news/news-details/2026/Alto-Neuroscience-Announces-Completion-of-Enrollment-in-Phase-2-Proof-of-Concept-Study-of-ALTO-101-in-Cognitive-Impairment-Associated-with-Schizophrenia/default.aspx
Context: The study is designed to assess ALTO-101’s effects on brain activity and cognitive performance, using EEG and cognitive testing.
Key point: Alto Neuroscience completed patient enrollment for its Phase 2 study evaluating ALTO-101, a PDE4 inhibitor, in cognitive impairment associated with schizophrenia (CIAS).
Implication: If successful, ALTO-101 could be a first-in-class treatment for cognitive dysfunction in schizophrenia, a major unmet need.

Why it matters

  • UPLIZNA® in myasthenia gravis provides a new treatment option, particularly for patients with limited options for long-term disease control.
  • bocunebart’s success in migraine prevention offers hope for those with treatment-resistant migraines, potentially changing treatment paradigms.
  • Immunic’s financial boost positions it to make strides in MS therapy commercialization, expanding treatment options for patients.
  • OT-101’s expanded IP offers more robust protection, bolstering its potential in CNS and oncology applications.
  • Denovo Biopharma’s partnership on psychosis treatment could provide much-needed new approaches for young patients.
  • Soin Neuroscience and Lilac Biosciences’ collaboration in pain research may introduce objective measures for pain management.
  • ALTO-101 could offer a novel approach to cognitive impairment in schizophrenia, providing a potential breakthrough in an underserved area.

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FAQ

What did Amgen’s approval of UPLIZNA® in Europe mean for gMG patients?

It offers a new, targeted treatment with twice-yearly maintenance dosing, potentially improving long-term disease management and reducing steroid use [1].

What does Lundbeck’s bocunebart show for migraine prevention?

The Phase IIb trial demonstrated a significant reduction in monthly migraine days in patients with a history of treatment failures, with a strong safety profile [2].

What is the regulatory status of Immunic’s $400 million funding?

The funding will support Immunic’s transition to a commercial-stage company, facilitating its Phase 3 trials in multiple sclerosis and preparations for commercialization [3].

How does Oncotelic’s IP expansion impact OT-101?

The expanded IP strengthens OT-101’s commercial position in CNS and oncology, offering broader protection for its therapeutic use and delivery methods [4].

What is Denovo’s partnership with Orygen on psychosis?

The partnership will investigate DB103 in first-episode psychosis, targeting the glutamate system, with the potential to offer new treatments for young patients [5].

What is Soin Neuroscience’s collaboration with Lilac Biosciences?

The collaboration aims to identify RNA signatures linked to pain and neuromodulation, advancing the development of neuromodulation therapies [6].

What is Alto Neuroscience’s study on ALTO-101?

The Phase 2 study is focused on evaluating ALTO-101 in cognitive impairment associated with schizophrenia, using EEG measures to assess its efficacy [7].

Entities / Keywords

UPLIZNA; inebilizumab; gMG; generalized myasthenia gravis [1]
bocunebart; Lu AG09222; anti-PACAP; migraine prevention [2]
Immunic; vidofludimus calcium; multiple sclerosis [3]
OT-101; TGF-β antisense; neurology; oncology [4]
DB103; pomaglumetad methionil; psychosis [5]
Soin Neuroscience; Lilac Biosciences; RNA signatures; pain [6]
ALTO-101; PDE4 inhibitor; cognitive impairment; schizophrenia [7]

References

  1. https://investors.amgen.com/news-releases/news-release-details/european-commission-approves-amgens-upliznar-generalized
  2. https://news.cision.com/h–lundbeck-a-s/r/lundbeck-announces-positive-phase-iib-top-line-results-with-bocunebart–lu-ag09222–anti-pacap-mab–,c4307114
  3. https://www.prnewswire.com/news-releases/immunic-announces-oversubscribed-private-placement-of-up-to-usd-400-million-to-accelerate-transformation-into-commercial-stage-company-302687546.html
  4. https://www.globenewswire.com/news-release/2026/02/12/3237197/0/en/Oncotelic-Therapeutics-Inc-and-Sapu-Bioscience-Expand-International-IP-Coverage-for-OT-101-Strengthening-CNS-and-Neurology-Commercialization-Pathway.html
  5. https://www.manilatimes.net/2026/02/11/tmt-newswire/globenewswire/denovo-biopharma-announces-partnership-with-orygen-on-phase-2-study-evaluating-db103-pomaglumetad-methionil-in-treating-psychosis/2276204
  6. https://www.prnewswire.com/news-releases/soin-neuroscience-and-lilac-biosciences-launch-collaboration-to-study-rna-signatures-in-pain-and-neuromodulation-302687703.html
  7. https://investors.altoneuroscience.com/news/news-details/2026/Alto-Neuroscience-Announces-Completion-of-Enrollment-in-Phase-2-Proof-of-Concept-Study-of-ALTO-101-in-Cognitive-Impairment-Associated-with-Schizophrenia/default.aspx

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