CNS/neurology/psychiatry companies
94 listed CNS/neurology/psychiatry companies, largest first, with lead program and the next catalyst each has disclosed.
| Company | Ticker | Lead program | Indication | Next catalyst |
|---|---|---|---|---|
| Teva Pharmaceutical Industries Ltd | TEVA | AUSTEDO / AUSTEDO XR (deutetrabenazine) | Chorea associated with Huntington's disease; tardive dyskinesia | — |
| Biogen Inc. | BIIB | Leqembi (lecanemab) | Alzheimer's disease | — |
| Neurocrine Biosciences Inc | NBIX | INGREZZA (valbenazine) | tardive dyskinesia; chorea associated with Huntington's disease | — |
| TG Therapeutics, Inc. | TGTX | BRIUMVI (ublituximab-xiiy) | relapsing forms of multiple sclerosis (adults) | Q4 2026 — Topline data from Phase 3 in RMS |
| Axsome Therapeutics, Inc. | AXSM | AUVELITY (dextromethorphan-bupropion) | major depressive disorder | May 1, 2027 — FDA action on NDA (PDUFA) |
| Alkermes plc | ALKS | alixorexton | narcolepsy type 1 and type 2 | 2027 — Phase 2 ADHD study data expected in 2027. |
| Amneal Pharmaceuticals, Inc. | AMRX | CREXONT | Parkinson's disease / CNS disorders (Specialty segment) | — |
| Praxis Precision Medicines, Inc. | PRAX | relutrigine | SCN2A and SCN8A developmental and epileptic encephalopathies (DEEs) | December 27, 2026 — PDUFA action date (NDA, priority review, extended three months) |
| Lantheus Holdings, Inc. | LNTH | MK-6240 (F-18 tau PET imaging agent) | PET detection of tau neurofibrillary tangle pathology in patients with cognitive impairment evaluated for Alzheimer's disease | Q4 2026 — Commercial availability (rolling geographic launch) |
| Definium Therapeutics, Inc. | DFTX | DT120 ODT (lysergide D-tartrate; formerly MM120) | Generalized anxiety disorder (also MDD and PTSD) | 2026 — Initial Phase 2a data in adult ASD |
| Indivior Pharmaceuticals, Inc. | INDV | SUBLOCADE (buprenorphine extended-release monthly injection) | Opioid use disorder | — |
| Regencell Bioscience Holdings Limited | RGC | Standardized TCM Formula for ADHD and ASD | Attention Deficit Hyperactivity Disorder (ADHD) and Autism Spectrum Disorder (ASD) | — |
| Xenon Pharmaceuticals Inc. | XENE | azetukalner (XEN1101) | focal onset seizures (epilepsy) | H2 2026 — Complete Phase 1 SAD/MAD to support Phase 2 in acute pain |
| Acadia Pharmaceuticals Inc | ACAD | remlifanserin (ACP-204) | hallucinations and delusions associated with Alzheimer's disease psychosis (ADP); also Lewy Body Dementia Psychosis | November 2026 — Detailed Phase 2 RADIANT results to be presented at CTAD conference in November 2026. |
| Supernus Pharmaceuticals, Inc. | SUPN | Qelbree (viloxazine extended-release) | ADHD in pediatric patients 6+ and adults | H2 2026 — Initiate Phase 1 SAD/MAD study in healthy volunteers |
| Harmony Biosciences Holdings, Inc. | HRMY | Pitolisant GR (gastro-resistant formulation) | Narcolepsy | Q4 2026 — Phase 1 MAD topline data |
| Biohaven Ltd. | BHVN | Opakalim (BHV-7000) | Refractory focal epilepsy (adults) | H2 2026 — RISE 3 topline results |
| Stoke Therapeutics, Inc. | STOK | zorevunersen (STK-001) | Dravet syndrome | H2 2026 — Pre-NDA meeting with FDA |
| uniQure N.V. | QURE | AMT-130 | Huntington's disease | — |
| COMPASS Pathways plc | CMPS | COMP360 psilocybin treatment | Treatment-resistant depression (TRD) | 2027 — Potential FDA approval and first product revenue |
| Korsana Biosciences, Inc. | KRSA | CYC-126 | treatment-resistant depression (propofol + dexmedetomidine with personalized delivery/monitoring system) | — |
| LB Pharmaceuticals Inc | LBRX | LB-102 | acute schizophrenia (pivotal Phase 3 NOVA-2) | H2 2027 — Initiation of trial in negative symptoms of schizophrenia |
| Rapport Therapeutics, Inc. | RAPP | RAP-219 | drug-resistant focal onset seizures | H2 2027 — FDA meeting planned Q1 2027 on bipolar mania registrational design; two Phase 3 trials expected to begin 2H 2027. |
| GH Research PLC | GHRS | GH001 | Treatment-resistant depression (TRD) | — |
| Seaport Therapeutics, Inc. | SPTX | GlyphAllo (SPT-300), oral Glyphed prodrug of allopregnanolone | major depressive disorder (MDD) with or without anxious distress | H2 2026 — Topline data from Phase 1 driving simulation trial |
| Alto Neuroscience, Inc. | ANRO | ALTO-207 | Treatment-resistant depression | H1 2027 — Phase 2b topline data |
| Helus Pharma Inc. | HELP | HLP003 (deuterated psilocin, oral) | Adjunctive treatment of major depressive disorder (MDD) | Q4 2026 — Topline data readout from APPROACH Phase 3 study of HLP003 for adjunctive treatment of major depressive disorder on track for Q4 2026. |
| Annexon, Inc. | ANNX | tanruprubart (ANX005) | Guillain-Barre Syndrome (GBS) | Q4 2026 — ARCHER II Phase 3 Month 15 primary endpoint readout |
| Achieve Life Sciences, Inc. | ACHV | cytisinicline | smoking cessation (nicotine dependence); also vaping cessation | H1 2027 — Potential FDA approval |
| MapLight Therapeutics, Inc. | MPLT | ML-007C-MA | Schizophrenia | H2 2027 — VISTA Phase 2 topline |
| Bright Minds Biosciences Inc. | DRUG | BMB-101 | drug-resistant epilepsies (absence epilepsy, developmental epileptic encephalopathy); Prader-Willi syndrome | — |
| Neurogene Inc. | NGNE | NGN-401 | Rett syndrome | 2026 — Complete process performance qualification (PPQ) runs |
| DiaMedica Therapeutics Inc. | DMAC | DM199 (rinvecalinase alfa; rhKLK1) | acute ischemic stroke (ReMEDy2 Phase 2/3); preeclampsia and fetal growth restriction (Phase 2) | October 2026 — Rat PK/pharmacologic activity study completion, then submission to FDA to support IND |
| Brainsway Ltd. | BWAY | Deep TMS system (H-Coil) | Major depressive disorder (incl. anxious depression), OCD, smoking addiction | — |
| NeuroPace Inc | NPCE | RNS System | Drug-resistant focal epilepsy (adults); label expansion studies in idiopathic generalized epilepsy and ages 12-17 | — |
| Ovid Therapeutics Inc. | OVID | OV329 | treatment-resistant focal onset seizures (also TSC-associated seizures, infantile spasms) | Q4 2026 — Initiate proof-of-concept study in TSC-associated seizures |
| Prothena Corp Public Ltd Co | PRTA | PRX012 | Alzheimer's disease | — |
| Mobia Medical, Inc. | MOBI | Vivistim Paired VNS System | Chronic ischemic stroke with moderate to severe upper extremity impairment | — |
| Kyverna Therapeutics, Inc. | KYTX | miv-cel (KYV-101) | Stiff person syndrome | Q4 2026 — Complete rolling BLA submission |
| ClearPoint Neuro, Inc. | CLPT | ClearPoint Neuro Navigation System (MRI-guided neurosurgical platform) | Minimally invasive neurosurgery / intracranial delivery | — |
| Alector, Inc. | ALEC | AL137 | Alzheimer's disease | January 2, 2027 — Termination effective |
| AC Immune SA | ACIU | ACI-7104.056 | early-stage Parkinson's disease | Q1 2027 — FDA meetings on Part 2 (expansion) design of VacSYn |
| Keros Therapeutics, Inc. | KROS | rinvatercept (KER-065) | Duchenne muscular dystrophy (DMD); ALS planned | H2 2026 — Engage regulators on design of Phase 2 trial in ALS |
| Camp4 Therapeutics Corp | CAMP | CMP-002 | SYNGAP1-related disorder (developmental and epileptic encephalopathy) | Q4 2026 — Initiation of Phase 1/2 clinical trial in SYNGAP1 |
| Cartesian Therapeutics, Inc. | RNAC | Descartes-08 | Myasthenia gravis | Q1 2027 — Topline data from Phase 3 AURORA trial of Descartes-08 in myasthenia gravis expected in first quarter of 2027. |
| Alpha Cognition Inc. | ACOG | ZUNVEYL (benzgalantamine) | Mild to moderate dementia of the Alzheimer's type | — |
| Neuronetics, Inc. | STIM | NeuroStar Advanced Therapy System (TMS) | Major depressive disorder; adjunct for OCD; adolescent MDD (15-21); anxious depression | — |
| NervGen Pharma Corp. | NGEN | NVG-291 | Spinal cord injury (chronic and subacute tetraplegia) | — |
| Acumen Pharmaceuticals, Inc. | ABOS | sabirnetug (ACU193) | Early Alzheimer's disease (MCI or mild dementia due to AD) | H2 2026 — Phase 2 top-line results |
| Anavex Life Sciences Corp. | AVXL | ANAVEX 2-73 (blarcamesine) | Early Alzheimer's disease; Rett syndrome; Fragile X syndrome | November 2026 — Anavex has an FDA meeting scheduled for November to discuss adding pediatric participants to the Phase 3 Rett syndrome study. |
| Tiziana Life Sciences Ltd | TLSA | Foralumab (TZLS-401), intranasal anti-CD3 mAb | non-active secondary progressive multiple sclerosis; also Alzheimer's, MSA, ALS | — |
| Minerva Neurosciences, Inc. | NERV | roluperidone | negative symptoms of schizophrenia | H2 2027 — C19 Phase 3 topline efficacy results (12-week primary endpoint) |
| NRx Pharmaceuticals, Inc. | NRXP | NRX-100 (preservative-free IV ketamine) / NRX-101 (D-cycloserine + lurasidone) | Suicidal ideation in depression incl. bipolar depression (NRX-100); suicidal bipolar depression (NRX-101) | Q4 2026 — Commercial launch following ANDA approval |
| Voyager Therapeutics, Inc. | VYGR | VY7523 | Alzheimer's disease (anti-tau antibody) | H2 2026 — Initial tau PET imaging data |
| Immunic, Inc. | IMUX | vidofludimus calcium (IMU-838) | relapsing multiple sclerosis | 2026 — ENSURE-1 and ENSURE-2 topline data |
| Coya Therapeutics, Inc. | COYA | COYA 302 (low-dose IL-2 + CTLA4-Ig) | Amyotrophic lateral sclerosis (ALS) | — |
| Greenland Mines Ltd | GRML | KLTO-202 | Amyotrophic lateral sclerosis (Klotho gene therapy) | — |
| ProMIS Neurosciences Inc. | PMN | PMN310 | Early Alzheimer's disease | Q1 2027 — Unblinded 12-month topline data from PRECISE-AD |
| Cingulate Inc. | CING | CTx-1301 (dexmethylphenidate, PTR platform) | ADHD | date not stated — NDA resubmission following completion of requested CMC work |
| Neumora Therapeutics, Inc. | NMRA | NMRA-511 | Agitation in Alzheimer's disease (V1aR antagonist) | H2 2026 — NMRA-898 Phase 1 MAD data expected in the second half of 2026. |
| Medicinova Inc | MNOV | MN-166 (ibudilast) | ALS (COMBAT-ALS) | — |
| Cognition Therapeutics Inc | CGTX | zervimesine (CT1812) | early Alzheimer's disease; dementia with Lewy bodies | date not stated — START Phase 2 topline results |
| Clene Inc. | CLNN | CNM-Au8 | Amyotrophic lateral sclerosis (ALS) | Q4 2026 — NDA submission seeking accelerated approval |
| Gain Therapeutics, Inc. | GANX | Rexaceract (GT-02287) | Parkinson's disease with or without GBA1 mutation | — |
| Annovis Bio, Inc. | ANVS | Buntanetap | Early Alzheimer's disease | October 2026 — AD OLE start |
| Serina Therapeutics, Inc. | SER | SER-252 (POZ-apomorphine) | advanced Parkinson's disease | — |
| Grace Therapeutics, Inc. | GRCE | GTx-104 (IV nimodipine) | Aneurysmal subarachnoid hemorrhage (aSAH) | date not stated — NDA resubmission following CRL |
| Alterity Therapeutics Ltd | ATHE | ATH434 | Multiple System Atrophy (MSA) | 2026 — Initiation of Phase 3 trial activities in MSA |
| CervoMed Inc. | CRVO | neflamapimod | Dementia with Lewy bodies (DLB); also nfvPPA, RAS, ALS | H2 2026 — Initiation of planned Phase 3 trial |
| Filana Therapeutics, Inc. | FLNA | simufilam | Tuberous sclerosis complex-related epilepsy | date not stated — Resolution of FDA clinical hold on proposed TSC trial |
| Abvc Biopharma, Inc. | ABVC | ABV-1505 | Adult attention-deficit hyperactivity disorder (ADHD) | Q4 2026 — Phase II start |
| IGC Pharma, Inc. | IGC | IGC-AD1 | Agitation in Alzheimer's dementia | date not stated — CALMA Phase 2 completion / topline |
| Psyence Biomedical Ltd. | PBM | NPX-5 (nature-derived psilocybin 25 mg) | Adjustment disorder in patients with incurable cancer (palliative care) | November 2026 — Psyence expects to conclude definitive agreement with PsyLabs for exclusive ibogaine supply for the United States on or before November 30, 2026. |
| Aytu Biopharma, Inc | AYTU | EXXUA (gepirone) extended-release | major depressive disorder in adults | — |
| Quantum BioPharma Ltd. | QNTM | Lucid-MS (Lucid-21-302) | Multiple sclerosis | — |
| Neuphoria Therapeutics Inc. | NEUP | BNC210 (alpha7 nicotinic receptor negative allosteric modulator) | Post-traumatic stress disorder | 2026 — Expected close of proposed merger with Scancell Holdings plc |
| Optimi Health Corp. | OPTH | Botanical psilocybin drug product | treatment-resistant depression (TRD) | — |
| AEON Biopharma, Inc. | AEON | ABP-450 | Botulinum toxin (351(k) biosimilar to Botox; neurology/aesthetic indications) | H2 2026 — Written feedback from BPD Type 2b meeting with FDA |
| Lipocine Inc. | LPCN | LPCN 1154 | Postpartum depression | — |
| BioVie Inc. | BIVI | Bezisterim (NE3107) | Parkinson's disease | date not stated — Finalize Phase 3 design and endpoints with FDA |
| NEUROONE MEDICAL TECHNOLOGIES Corp | NMTC | Evo Cortical / Evo sEEG electrodes and OneRF Ablation Systems | Epilepsy diagnosis and ablation; trigeminal neuralgia pain (OneRF TN) | — |
| Vistagen Therapeutics, Inc. | VTGN | fasedienol (PH94B) nasal spray | acute treatment of anxiety in adults with social anxiety disorder | — |
| InMed Pharmaceuticals Inc. | INM | INM-901 | Alzheimer's disease | Q1 2027 — Pre-IND meeting |
| Enveric Biosciences, Inc. | ENVB | EB-003 | depression or other neuropsychiatric disorders | date not stated — IND filing |
| Alzamend Neuro, Inc. | ALZN | AL001 | Bipolar disorder (also Alzheimer's, MDD, PTSD) | Q4 2026 — Topline data, Phase II BD 'Lithium in Brain' study |
| Pulmatrix, Inc. | PULM | PUR3100 (inhaled dihydroergotamine, iSPERSE) | Acute migraine | 2026 — Licensee Cipla expected to commence Phase 3 (ex-US; not sponsored by Pulmatrix) |
| Addex Therapeutics Ltd. | ADXN | Dipraglurant (mGlu5 NAM) | Post-stroke / traumatic brain injury recovery | — |
| XTL Biopharmaceuticals Ltd | XTLB | Psyga Bio psilocybin-derived candidates (Phase 2a trials approved, not yet enrolling) | Treatment-resistant depression, PTSD, anorexia, addiction and other CNS/mental health disorders | H1 2027 — Commencement of at least three human clinical trials (milestone for earn-out shares) |
| NeuroSense Therapeutics Ltd. | NRSN | PrimeC (extended-release ciprofloxacin + celecoxib) | Amyotrophic lateral sclerosis (ALS) | — |
| Jupiter Neurosciences, Inc. | JUNS | JOTROL (enhanced oral resveratrol formulation) | Parkinson's disease | Q2 2027 — Phase IIa Parkinson's disease results |
| Clearmind Medicine Inc. | CMND | Psychedelic-derived candidates (e.g. MEAI-based) | Alcohol use disorder and other CNS indications | — |
| Silo Pharma, Inc. | SILO | SPC-15 | PTSD and stress-induced anxiety disorders (intranasal prophylactic) | 2026 — IND submission |
| Oragenics Inc | OGEN | ONP-002 | Mild traumatic brain injury (concussion) | Q4 2026 — Submit US IND (FDA Type B meeting requested July 2026) |
| SciSparc Ltd. | SPRC | SCI-110 (THC + PEA/CannAmide) | Tourette syndrome; Alzheimer's disease agitation | — |
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.