Therapeutic Area

Neurology

Therapeutic area intelligence for Neurology with 55 indexed intelligence signals across regulatory, clinical, competitive, and market developments.

Signals: 52
Catalysts: 3
Companies: 21

Companies

Assets

Recent signals(52)

ClinicalJune 21, 2026

Progress on EBV Vaccine Development Critical for MS Prevention

Research indicates that Epstein-Barr virus (EBV) is a primary trigger for multiple sclerosis (MS), emphasizing the need for an effective vaccine.

ClinicalJune 21, 2026

Study on MRI Findings and Executive Functions in Preterm Infants

This study aims to correlate MRI findings at term age in preterm infants with their executive functions and neurodevelopmental outcomes.

ClinicalJune 21, 2026

Teva's TEV-56286 Trial for Multiple System Atrophy Underway

Teva is conducting a trial to evaluate the efficacy and safety of TEV-56286 in adults with Multiple System Atrophy.

ClinicalJune 21, 2026

New Observational Study on Treatment Adaptation in Status Epilepticus

An observational multicenter cohort study aims to improve treatment outcomes in adult patients with status epilepticus through enhanced monitoring and management strategies.

ClinicalJune 21, 2026

Study on Core Stability and Functional Capacity in Pediatric Demyelinating Diseases

A study is underway to assess various physical capabilities in children with CNS demyelinating diseases.

RegulatoryJune 21, 2026

FDA Accepts Supplement for Levetiracetam ANDA204754 by Aiping Pharm

The FDA has accepted a supplemental application for ANDA204754, a generic version of levetiracetam, from Aiping Pharm.

RegulatoryJune 21, 2026

FDA Accepts Supplemental Application for Emgality (Galcanezumab) by Eli Lilly

The FDA has accepted a supplemental application for Emgality, CGRP inhibitor developed by Eli Lilly.

RegulatoryJune 21, 2026

FDA Accepts Supplement for AJOVY (Fremanezumab) by Teva Pharmaceuticals

The FDA has accepted a supplemental application for AJOVY (fremanezumab) from Teva Pharmaceuticals.

ClinicalJune 21, 2026

Fremanezumab Trial for Acute Mountain Sickness Shows Potential for CGRP Blockade

A clinical trial is investigating the efficacy of fremanezumab in preventing symptoms of acute mountain sickness (AMS) in healthy adults.

RegulatoryJune 20, 2026

FDA Accepts Supplement for VYEPTI (EPTINEZUMAB-JJMR) by Lundbeck

The FDA has accepted a supplemental application for VYEPTI, an anti-CGRP therapy for migraine.

RegulatoryJune 20, 2026

FDA Grants AP Status for Acetazolamide Sodium ANDA202693

The FDA has granted approval status (AP) for the Abbreviated New Drug Application (ANDA) 202693 for Acetazolamide Sodium submitted by Avet Lifesciences.

RegulatoryJune 20, 2026

FDA Accepts ANDA for Dextromethorphan Hydrobromide and Quinidine Sulfate by Sun Pharma

The FDA has accepted the Abbreviated New Drug Application (ANDA) for Dextromethorphan Hydrobromide and Quinidine Sulfate submitted by Sun Pharma.

ClinicalJune 20, 2026

Managed Access Program for Del-zota in DMD Patients Announced by Avidity Biosciences

Avidity Biosciences has launched Managed Access Program for delpacibart zotadirsen (AOC 1044) targeting DMD mutations suitable for exon 44 skipping.

ClinicalJune 20, 2026

Gene Transfer Study for Giant Axonal Neuropathy Initiated by NINDS

A clinical trial has been initiated to evaluate the safety and potential efficacy of scAAV9/JeT-GAN for treating Giant Axonal Neuropathy.

ClinicalJune 20, 2026

Study on Corticosteroids for Healing Ring-Enhancing Lesions in Multiple Sclerosis

A clinical trial is investigating the efficacy of high-dose corticosteroids on ring-enhancing lesions in MS patients.

RegulatoryJune 20, 2026

FDA Approves OTC Naloxone Nasal Spray Rextovy for Opioid Overdose

The FDA has approved Rextovy, a 4 mg naloxone nasal spray, for over-the-counter use in treating opioid overdose.

RegulatoryJune 19, 2026

Orbit Pharma recalls Cyclizine Lactate due to GMP deficiencies

Orbit Pharma Limited is recalling a batch of Cyclizine Lactate 50 mg/ml Solution for injection due to GMP deficiencies.

CompetitiveJune 19, 2026

Lupin's Divalproex Sodium ANDA209286 Receives Abbreviated Approval

Lupin has received an abbreviated approval for its ANDA209286 application for Divalproex Sodium.

RegulatoryJune 19, 2026

FDA Grants AP Status for Divalproex Sodium ANDA217358 by Mankind Pharma

The FDA has granted an Abbreviated New Drug Application (ANDA) approval status for Divalproex Sodium submitted by Mankind Pharma.

StrategyJune 19, 2026

FDA Approves Hydroxyzine Hydrochloride ANDA220271 by Saptalis Pharmaceuticals

The FDA has approved ANDA220271 for Hydroxyzine Hydrochloride submitted by Saptalis Pharmaceuticals.

ClinicalJune 19, 2026

Study on Genotype-Phenotype Correlation of MORC2 Mutations in Charcot-Marie-Tooth Disease

A clinical trial is underway to investigate the correlation between MORC2 mutations and various phenotypes in patients.

ClinicalJune 19, 2026

Pilot Study on Deep Brain Stimulation for Opioid Use Disorder Initiated

A pilot study is underway to assess the safety and efficacy of deep brain stimulation targeting the nucleus accumbens in patients with treatment-refractory opioid use disorder.

ClinicalJune 19, 2026

Study on Emotional Wellness in Stroke Rehabilitation Initiated

A clinical trial is evaluating the impact of emotional wellness components in stroke rehabilitation therapies.

ClinicalJune 19, 2026

Study on Cardiovascular Abnormalities in Children with ADHD Launched

A new study has been initiated to assess the prevalence and types of cardiovascular abnormalities in children diagnosed with ADHD.

ClinicalJune 19, 2026

AbbVie Initiates Trial for ABBV-932 in Bipolar Disorder Depressive Episodes

AbbVie is conducting a trial to evaluate the safety and efficacy of ABBV-932 in adults with depressive episodes linked to bipolar I or II disorder.

ClinicalJune 19, 2026

Study on 'Yanjiu Needle' for Pharyngeal Dysphagia Shows Promise in Stroke Patients

'Yanjiu Needle' technique may improve swallowing function in stroke patients through specific acupoint stimulation.

ClinicalJune 19, 2026

Pilot trial to assess cognitive function changes in Rett Syndrome during Trofinetide treatment

A pilot trial will evaluate cognitive function changes in Rett Syndrome patients during Trofinetide treatment using eye-tracking measures.

ClinicalJune 18, 2026

Risdiplam Study to Assess Real-World Outcomes in Type I and II SMA

A multicenter study will evaluate the real-world clinical outcomes and safety of Risdiplam in SMA patients over 24 months.

RegulatoryJune 18, 2026

FDA Approves Supplemental Application for REXTOVY by Amphastar Pharmaceuticals

The FDA has approved a supplemental application for REXTOVY, containing naloxone hydrochloride.

StrategyJune 18, 2026

FDA Grants Approval for Lacosamide ANDA217596

The FDA has granted approval for the Abbreviated New Drug Application (ANDA) 217596 for lacosamide.

RegulatoryJune 18, 2026

TARO's ANDA219052 for PERAMPANEL Receives Approval Status

TARO's ANDA219052 for PERAMPANEL has received an approval status (AP) from the FDA.

CompetitiveJune 18, 2026

FDA Submission Update for Topiramate by Aiping Pharm Inc.

Aiping Pharm Inc. has submitted an application (ANDA078499) for Topiramate with a standard review priority.

RegulatoryJune 18, 2026

FDA Accepts Supplement for Clonazepam by Rubicon Research

The FDA has accepted a supplemental application for Clonazepam submitted by Rubicon Research.

StrategyJune 18, 2026

Cipla's ANDA214209 for Sumatriptan Receives Abbreviated Approval from FDA

Cipla has received Abbreviated Approval (AP) from the FDA for its ANDA214209 application for Sumatriptan.

StrategyJune 18, 2026

FDA Approval Update for Divalproex Sodium by Mylan

The FDA has granted an Abbreviated New Drug Application (ANDA) approval for Divalproex Sodium submitted by Mylan.

StrategyJune 18, 2026

FDA Grants Abbreviated Approval for Divalproex Sodium by Unichem

The FDA has granted an abbreviated approval for Divalproex Sodium under application ANDA214643 submitted by Unichem.

RegulatoryJune 18, 2026

FDA Accepts Supplement Application for ENSPRYNG (Satralizumab)

The FDA has accepted the supplemental application for ENSPRYNG (satralizumab) submitted by Genentech.

ClinicalJune 17, 2026

Launch of Alzheimer's Disease Neuroimaging Initiative 4 to Validate Biomarkers

The Alzheimer's Disease Neuroimaging Initiative 4 (ADNI4) aims to validate biomarkers and improve clinical trial design for Alzheimer's disease.

ClinicalJune 17, 2026

Phase 3 Trial of Orelabrutinib in Secondary Progressive MS Underway

A phase 3 trial is evaluating the efficacy and safety of orelabrutinib, CNS-penetrable BTK inhibitor, in patients with non-active Secondary Progressive MS.

ClinicalJune 17, 2026

Analysis Reveals Key Trends in ALS Immunotherapeutics Research and Collaboration Gaps

The bibliometric analysis highlights a significant increase in ALS immunotherapeutics research, with a shift towards advanced immunomodulatory strategies and regulatory T cell modulation.

ClinicalJune 17, 2026

ACADIA Pharmaceuticals initiates ACP-204 trials for Alzheimer's Disease Psychosis

ACADIA Pharmaceuticals is launching a master protocol for three independent studies evaluating ACP-204 in Alzheimer's Disease Psychosis.

ClinicalJune 17, 2026

Roche's ENSPRYNG shows 68% relapse reduction in Phase III MOGAD study

The Phase III METEOROID study demonstrated that ENSPRYNG (satralizumab) reduced the risk of relapses by 68% in MOGAD patients.

RegulatoryJune 16, 2026

Roche's Elecsys® pTau217 Blood Test Receives CE Mark for Alzheimer's Detection

Roche has received CE Mark approval for Elecsys® pTau217, the first blood test designed to detect Alzheimer's disease pathology.

RegulatoryJune 16, 2026

Roche's Elecsys® pTau217 Blood Test Receives CE Mark for Alzheimer's Diagnosis

Roche has received CE Mark approval for Elecsys® pTau217, the first blood test for Alzheimer's disease pathology, enabling faster diagnosis.

ClinicalJune 10, 2026

Pridopidine Phase 3 Trial Initiated for ALS Efficacy and Safety Evaluation

A Phase 3 clinical trial is underway to evaluate the efficacy and safety of pridopidine in treating amyotrophic lateral sclerosis (ALS).

RegulatoryJune 10, 2026

FDA Accepts Supplement for SPRAVATO (Esketamine Hydrochloride)

The FDA has accepted a supplemental application for SPRAVATO, indicating ongoing development and potential label expansion.

StrategyJune 9, 2026

FDA Grants Approval for Pimozide ANDA219897 by Novitium Pharma

The FDA has granted approval for ANDA219897, a generic formulation of Pimozide submitted by Novitium Pharma.

RegulatoryJune 9, 2026

FDA Accepts Supplemental Application for Concerta by Janssen

The FDA has accepted a supplemental application for Concerta, a medication containing methylphenidate hydrochloride.

RegulatoryJune 7, 2026

Glenmark Pharmaceuticals submits supplemental application for Lamotrigine

Glenmark Pharmaceuticals has submitted a supplemental application for Lamotrigine under ANDA090169, currently under standard review.

RegulatoryJune 7, 2026

Alembic's Duloxetine Hydrochloride Supplement Receives AP Status from FDA

Alembic's application for Duloxetine Hydrochloride has received an Abbreviated Approval (AP) status from the FDA.

StrategyJune 6, 2026

Aurobindo Pharma's Lamotrigine ANDA Submission Receives AP Status

Aurobindo Pharma's ANDA078956 for Lamotrigine has received an Abbreviated Approval (AP) status from the FDA.

RegulatoryJune 6, 2026

FDA Approves Supplement for Levetiracetam by Chartwell RX

The FDA has approved a supplemental application for levetiracetam submitted by Chartwell RX.

Upcoming catalysts(2)

FDA Approval

Biogen — Leqembi

Subcutaneous formulation approval could expand addressable patient pool and access.

August 1, 2026 · NDA/BLA

Advisory Committee

Eli Lilly — Donanemab

AdCom outcome will signal FDA tolerance for amyloid-lowering therapies in broader populations.

July 8, 2026 · NDA/BLA

Indications

Alzheimer's Disease →

Alzheimer's disease (subcutaneous) →

Autoimmune Disease →

Autoimmune Disorders →

Bipolar Disorder →

Charcot-Marie-Tooth Disease →

Infectious Disease →

Multiple sclerosis →

Neurodevelopmental Disorders →

Opioid Use Disorder →

Pediatric Demyelinating Diseases →

Rett Syndrome →

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