Drugs / exidavnemab
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06671938 | Oct 2024 → Aug 2026 overdue | Parkinson disease, multiple system atrophy | BioArctic AB | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2025-06-13 | BioArctic AB | Results BioArctic to initiate next cohorts in exidavnemab Phase 2a study after positive safety review bioarctic.com ↗
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the interim safety review of the clinical Phase 2a study EXIST showed exidavnemab to be safe and well-tolerated, whereby the second dose cohorts will now be initiated. |
| 2025-05-22 | BioArctic AB | Regulatory BioArctic receives positive opinion for Orphan Medicinal Product Designation in the EU for exidavnemab in Multiple System Atrophy bioarctic.com ↗
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that The European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) recommends granting orphan medicinal product designation to exidavnemab for the treatment of Multiple System Atrophy (MSA), providing incentives for the development of treatments for rare diseases with a high medical need. |
| 2025-05-08 | BioArctic AB | Regulatory Exidavnemab phase 2a study expanded to include MSA patients bioarctic.com ↗ |
| 2025-04-23 | BioArctic AB | Regulatory BioArctic receives European substance patent for exidavnemab bioarctic.com ↗
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the European Patent Office, EPO, has issued a decision to grant European patent EP4172199B1 for exidavnemab, a drug candidate being developed as a treatment for synucleinopathies such as Parkinson’s disease and Multiple System Atrophy (MSA). |
| 2025-04-07 | BioArctic AB | Results Exidavnemab and lecanemab data presented at the 2025 AD/PD™ congress bioarctic.com ↗
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) presented data on exidavnemab and lecanemab at the 2025 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD™), held in Vienna, Austria, April 1-5. |
| 2025-03-17 | BioArctic AB | Regulatory BioArctic receives Orphan Drug Designation for exidavnemab the US bioarctic.com ↗
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the US FDA Office of Orphan Products Development (OOPD) has granted orphan drug designation (ODD) to exidavnemab for the treatment of Multiple System Atrophy (MSA), providing incentives for the development of treatments for rare diseases with a high medical need. |
| 2024-08-27 | BioArctic AB | Results Study results from phase 1 studies with exidavnemab published in The Journal of Clinical Pharmacology bioarctic.com ↗
BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) announced today that the results from two phase-1 studies with exidavnemab have been published in The Journal of Clinical Pharmacology. |
All press releases naming this drug 8 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | exidavnemab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06671938 ↗ |
| Route | Intravenous | “administered as an intravenous (IV) infusion” NCT06671938 ↗ |