Clinical trials
catalyst calendar across sponsors →Studies where AMLX is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
11 interventional · 2 expanded access · 3 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| AMX0114 in Adult Participants With Amyotrophic Lateral SclerosisNCT06665165Evaluate the safety and tolerability of AMX0114 in adult participants living with ALSRandomized · Quadruple-masked · Treatment | Phase 1 | Recruiting | Drug: AMX0114 · Other: Placebo | ALS | 48 | Feb 2027 | ≤ 193 d | 2026-04-14 |
| Avexitide for Treatment of Post-Bariatric HypoglycemiaNCT06747468Composite rate of Level 2 and Level 3 hypoglycemic eventsRandomized · Double-masked · Treatment | Phase 3 | Active, not recruiting | Drug: Avexitide · Other: Placebo | Post Bariatric Hypoglycemia | 75 | Mar 2026 | — | 2026-03-04 |
| AMX0035 in Adult Patients With Wolfram SyndromeNCT05676034To evaluate the effect of AMX0035 on residual beta-cell function by monitoring C-peptide levels during a 0-240 minutes mixed-meal tolerance test (MMTT)Open-label · Treatment | Phase 2 | Active, not recruiting | Drug: AMX0035 | Wolfram Syndrome | 12 | 2024-07-23actual | — | 2026-04-14 |
| Phase III Trial of AMX0035 for Amyotrophic Lateral Sclerosis TreatmentNCT05021536Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Slope ChangeRandomized · Quadruple-masked · Treatment | Phase 3 | Active, not recruiting | Other: Placebo · Drug: AMX0035 | Amyotrophic Lateral Sclerosis | 664 | 2024-01-19actual | — | 2024-08-14 |
| AMX0035 and Progressive Supranuclear PalsyNCT06122662Change in total (28-item) Progressive Supranuclear Palsy Rating Scale (PSPRS) ScoreRandomized · Quadruple-masked · Treatment | Phase 2/3 | Completed | Drug: AMX0035 · Other: Placebo | Progressive Supranuclear Palsy, PSP, Neurodegenerative Diseases, Atypical Parkinsonism | 139 | 2025-09-30actual | — | 2026-04-30 |
| Extension Study Evaluating The Safety And Tolerability of AMX0035NCT05619783To assess the Incidence of Treatment-Emergent Adverse Events during treatment with AMX0035Open-label · Treatment | Phase 3 | Completed | Drug: AMX0035 | Amyotrophic Lateral Sclerosis | 352 | 2024-10-16actual | — | 2025-01-13 |
| A Compassionate Use Protocol of AMX0035 for Treatment of Patients With Amyotrophic Lateral Sclerosis (ALS)NCT04516096Treatment emergent Adverse EventsOpen-label · Treatment | Phase 2/3 | Completed | Drug: AMX0035 | Amyotrophic Lateral Sclerosis | 28 | 2022-12-30actual | — | 2023-04-07 |
| Pharmacokinetic and Pharmacodynamic Study of AMX0035 in Patients With ALSNCT04987671Blood concentration of PB and taurursodiolOpen-label · Treatment | Phase 1/2 | Unknown status | Drug: AMX0035 | ALS | 14 | 2022-05-11actual | — | 2023-07-24 |
| Open Label Extension Study of AMX0035 in Patients With ALSNCT03488524results2025-08-13Number of Participants With Treatment-Emergent Adverse Events (TEAEs)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan: Primary SAP ↗ · Statistical Analysis Plan: Integrated Survival Analysis SAP ↗ · Statistical Analysis Plan: Addendum to Integrated Survival Analysis SAP ↗ | Phase 2 | Completed | Drug: AMX0035 | Amyotrophic Lateral Sclerosis, ALS | 90 | 2021-03-01actual | — | 2025-08-13 |
| Study to Assess the Safety and Biological Activity of AMX0035 for the Treatment of Alzheimer's DiseaseNCT03533257results2025-03-07Number of Participants With Treatment-Emergent Adverse Event (TEAEs)Randomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: AMX0035, Placebo | Alzheimer Disease | 95 | 2020-10-22actual | — | 2025-03-07 |
| AMX0035 in Patients With Amyotrophic Lateral Sclerosis (ALS)NCT03127514results2021-08-11Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Slope ChangeRandomized · Quadruple-masked · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: AMX0035 · Other: Placebo | Amyotrophic Lateral Sclerosis, Motor Neuron Disease, Neuromuscular Diseases, Neurodegenerative Diseases, Spinal Cord Diseases, TDP-43 Proteinopathies, Nervous System Diseases, Central Nervous System Diseases | 137 | 2019-09-25actual | — | 2024-05-16 |
| An Intermediate Size Expanded Access Protocol of AMX0035 for ALSNCT05286372expanded access | — | Approved for marketing | Drug: AMX0035 | Amyotrophic Lateral Sclerosis | — | — | — | 2022-10-18 |
| An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric HypoglycemiaNCT07582874expanded access | — | Available | Drug: Avexitide | Post-bariatric Hypoglycemia | — | — | — | 2026-07-14 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19