Amylyx Pharmaceuticals
Clinical-stage pharmaceutical company focused on developing investigational therapies for diseases with high unmet needs. The organization advances a modality-agnostic pipeline using mechanism-driven selection, preclinical and clinical development, regulatory interactions, and external collaborations. The company has experience across early- and late-phase clinical trials, regulatory submissions and designations, expanded access programs, and translational research in neurodegeneration and rare diseases.
Industries
Nr. of Employees
medium (51-250)
Amylyx Pharmaceuticals
Patents
Products
Investigational combination therapy targeting ER stress and mitochondrial dysfunction
An investigational small-molecule combination hypothesized to target endoplasmic reticulum stress and mitochondrial dysfunction for neurodegenerative diseases (investigational clinical development program).
GLP-1 receptor antagonist therapeutic candidates for post-bariatric hypoglycemia and rare diseases
Investigational GLP-1 receptor antagonist candidates developed for post-bariatric hypoglycemia and related rare indications, including long-acting formulations evaluated in IND-enabling studies.
Early-phase investigational therapies for ALS
Early clinical-stage investigational candidates being evaluated in Phase 1 studies for amyotrophic lateral sclerosis.
Investigational combination therapy targeting ER stress and mitochondrial dysfunction
An investigational small-molecule combination hypothesized to target endoplasmic reticulum stress and mitochondrial dysfunction for neurodegenerative diseases (investigational clinical development program).
GLP-1 receptor antagonist therapeutic candidates for post-bariatric hypoglycemia and rare diseases
Investigational GLP-1 receptor antagonist candidates developed for post-bariatric hypoglycemia and related rare indications, including long-acting formulations evaluated in IND-enabling studies.
Early-phase investigational therapies for ALS
Early clinical-stage investigational candidates being evaluated in Phase 1 studies for amyotrophic lateral sclerosis.
Services
Sponsorship and operational execution of early- and late-phase clinical trials, including global enrollment and program management.
Sponsorship and operational execution of early- and late-phase clinical trials, including global enrollment and program management.
Expertise Areas
- Clinical trial management
- Regulatory strategy and submissions
- Translational neuroscience and neurodegeneration
- Rare disease therapeutics development
Key Technologies
- Phase 1–3 clinical trial platforms
- IND-enabling nonclinical testing
- Biomarker-driven translational research
- In vitro neuronal viability assays
News & Updates
Announcement of topline data from a Phase 3 trial evaluating a GLP-1 receptor antagonist candidate in post-bariatric hypoglycemia (LUCIDITY).
Company reported completion of Phase 3 enrollment for a PBH trial and that IND-enabling studies are underway for a long-acting GLP-1 receptor antagonist selected through a research collaboration.
Announcement of the pricing of an upsized underwritten public offering of common stock.
Historical approvals in multiple jurisdictions followed by subsequent regulatory interactions and voluntary discontinuation processes to manage market authorizations and access.
Completed initial public offering and began trading on NASDAQ.
Clinical trial results from early studies were published in peer-reviewed journals.
Announcement of topline data from a Phase 3 trial evaluating a GLP-1 receptor antagonist candidate in post-bariatric hypoglycemia (LUCIDITY).
Company reported completion of Phase 3 enrollment for a PBH trial and that IND-enabling studies are underway for a long-acting GLP-1 receptor antagonist selected through a research collaboration.
Announcement of the pricing of an upsized underwritten public offering of common stock.
Historical approvals in multiple jurisdictions followed by subsequent regulatory interactions and voluntary discontinuation processes to manage market authorizations and access.
Completed initial public offering and began trading on NASDAQ.
Clinical trial results from early studies were published in peer-reviewed journals.