Amylyx Pharmaceuticals, Inc. today announced its intention to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for AMX0035 (sodium phenylbutyrate (PB) and taurursodiol (TURSO)) for the treatment of ...
Amylyx Pharmaceuticals, Inc. today announced its intention to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for AMX0035 (sodium phenylbutyrate (PB) and taurursodiol (TURSO)) for the treatment of ...
- Amylyx Adds Data from CENTAUR to the Anonymized PRO-ACT Database, the Largest ALS Clinical Trial Dataset Ever Created - Company Also Donates Patient Samples from CENTAUR to the Northeast ALS Consortium (NEALS) Biorepository Housed at ...
Amylyx Pharmaceuticals, Inc. today announced that Health Canada has accepted for review the New Drug Submission (NDS) for AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). “We are pleased that our submission has been ...
Funding to support advancement of clinical development and potential launch planning of AMX0035 in ALS and further research and development in additional neurodegenerative diseases Amylyx Pharmaceuticals, Inc. today announced the closing of an oversubscribed $135 million ...
Amylyx Pharmaceuticals, Inc. today announced the addition of Daphne Quimi to its Board of Directors. Ms. Quimi brings more than 25 years of executive experience in the pharmaceutical and biotechnology industries with expertise in global finance ...
- Submission Supported by Data from the CENTAUR Trial - CENTAUR Evaluated the Safety and Efficacy of AMX0035 in People with ALS and Demonstrated Statistically Significant Benefit in Function and Survival with Similar Rates of Adverse ...
- Building on Statistically Significant Findings from Phase 2 CENTAUR Trial, PHOENIX to Include 600 People with ALS and Broader Inclusion Criteria - Trial in Europe and U.S. Expected to Begin in Q3 2021 to Support Regulatory Submissions ...
- Marketing Authorization Application (MAA) Submission in Europe Planned for Q4 2021 - Phase 3 Trial in Europe and U.S. Expected to Begin in Q3 2021 to Support Regulatory Submissions Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on ...
- Abstract Awarded Merit of Distinction and Selected for Oral Presentation in Contemporary Clinical Issues Plenary Session - Abstract Will Be Featured at AAN’s Top Science Press Conference Ahead of Annual Meeting on April 13 Amylyx ...
Former Boehringer Ingelheim U.S. CEO Adds More than Thirty Years of Executive Leadership Experience and Commercial Expertise to the Amylyx Board of Directors Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments ...
– Significantly Lower Long-Term Risk of Death or Permanent Assisted Ventilation and Risk of First Hospitalization Among Participants Originally Randomized to AMX0035 Versus Placebo – Data were Consistent with CENTAUR and CENTAUR OLE Primary Outcome Measures of ...
- Marketing Application in Canada (New Drug Submission) Planned for First Half of 2021 - Amylyx Also Plans to Pursue Early Access Options in Canada Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for ...
#ShowYourStripes In Community Solidarity by Using New Facebook Filter or Downloadable Video Conferencing Background Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s Disease and other ...
- Former Alkermes Chief Financial Officer Expands Amylyx Executive Leadership Team as the Company Grows and Scales Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s Disease ...
Amylyx Continues to Expand Leadership Team to Support Clinical Development and Commercial Growth Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s Disease and other neurodegenerative ...
- Administration of AMX0035 Is Associated with a Statistically Significant Retention of Functional Abilities and Long-Term Survival Benefit in People Living with ALS - New Analysis Using ENCALS Survival Prediction Model Demonstrates Longer Overall Survival Resulting ...
Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and other neurodegenerative diseases, today announced that the U.S. Food and Drug Administration (FDA) has ...
Topline Results Expected in the First Half of 2021 Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and other neurodegenerative diseases, today announced that the ...
Data From CENTAUR Trial Published in Muscle & Nerve Demonstrates That Administration of AMX0035 Results in Longer Survival for People With ALS Early Administration of AMX0035 Reduced the Risk of Death by 44% Over the Duration ...
Data from New Long-Term Safety Analysis Show No New Safety Concerns with AMX0035 Identified in the Open-Label Extension Study Data Were Consistent with Primary Outcome of Statistically Significant Slowing of the Functional Decline Associated with ...