Amylyx
30 articles about Amylyx
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Known as Relyvrio in the U.S., Amylyx’s AMX0035 may face a longer road to approval in Europe as the company reported that CHMP could reject its marketing authorization application.
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The FDA’s approval of Amylyx's Relyvrio has ignited the growing momentum in the ALS space. BioSpace spoke with Amylyx co-CEOs Justin Klee and Josh Cohen and leading ALS researcher Dr. Merit Cudkowicz.
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There are several approaches on the horizon in ALS, a space that is gaining momentum. BioSpace spoke with GeNeuro, NeuroSense and the Tisch MS Research Center about their progress.
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Wednesday evening, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted 7-2 to recommend approval of Amylyx ALS candidate AMX0035.
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Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers.
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Amylyx Pharmaceuticals Announces Publication of CENTAUR Survival Data Demonstrating Statistically Significant Survival Benefit of AMX0035 for People with ALS
10/16/2020
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 of Follow-Up AMX0035 is the First ALS Therapeutic to Demonstrate Both a Statistically Significant Survival and Functional Benefit in ALS in a Randomized Controlled Trial
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Amylyx Pharmaceuticals published data from its Phase II/III CENTAUR clinical trial evaluating AMX0035 in amyotrophic lateral sclerosis (ALS) which met its primary endpoint.
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Amylyx Pharmaceuticals Announces New England Journal of Medicine Publication of Pivotal AMX0035 Data Demonstrating Statistically Significant Benefit in People with ALS
9/2/2020
Patients Retained Function Longer on AMX0035 Versus Placebo; Study Achieved Its Primary Outcome of a Difference on the Revised ALS Functional Rating Scale - AMX0035 is the First Investigational Therapy to Demonstrate Statistically Significant Benefit on this Prespecified Primary Outcome in People with ALS Since Approved Therapy Edaravone - AMX0035 Showed Numerical Benefits on Secondary Outcomes Including Measures of Muscle Strength, Brea
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ALS Association, I AM ALS Call On FDA, Amylyx to Make AMX0035 Available to People with ALS
9/2/2020
In response to the New England Journal of Medicine publication of encouraging clinical trial results showing that Amylyx Pharmaceuticals' AMX0035 brought statistically significant benefit to people living with ALS, The ALS Association and I AM ALS immediately called on the drug company and the FDA to make the treatment widely available as soon as possible.
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BioSpace Movers & Shakers, Aug. 28
8/28/2020
Biopharma and life sciences companies strengthen their leadership teams and boards with these Movers & Shakers. -
Amylyx to Continue Pioneering New Treatments for Neurodegenerative Diseases with $30M in Funding
7/2/2020
Massachusetts-based Amylyx Pharmaceuticals, a company focused on developing new treatments for neurodegenerative diseases, announced today that it had concluded a $30 million Series B round of financing. -
Amylyx Pharmaceuticals Raises $30 Million in Series B Funding
7/1/2020
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 it has closed an oversubscribed $30 mil
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Amylyx Pharmaceuticals Announces Completion of Enrollment in the PEGASUS Trial of AMX0035 in Alzheimer’s Disease
6/15/2020
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 it has completed enrollment in the Phase II PEGASUS trial assessing AMX0035 in individuals with Alzheimer’s disease. Amylyx completed
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Machelle Manuel, Ph.D., Joins Amylyx Pharmaceuticals as Vice President, Head of Global Medical Affairs
5/11/2020
May 11, 2020 13:00 UTC New Vice President of Medical Affairs Brings 20+ Years of Experience to Growing Leadership Team CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, today announced the appointment of Machelle Manuel, Ph.D., as Vice President, Head of Global Medical Affairs. Dr. Manuel brings more than 20 years of e
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Amylyx Pharmaceuticals Gets #INKEDforALS
5/4/2020
Company Launches #INKEDforALS Campaign in its Commitment to Raising Awareness for the ALS Community During ALS Awareness Month
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BioSpace Movers & Shakers: Feb. 7
2/7/2020
Pharma and biotech companies strengthen their leadership teams and boards with this weeks appointments. -
Amylyx Pharmaceuticals Appoints Jeffrey Trigilio Chief Financial Officer
2/4/2020
New Chief Financial Officer Brings Expertise in Business Development and Pipeline Diversification Planning Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, today announced the appointment of Jeffrey Trigilio as the company’s first Chief Financial Officer.
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Amylyx Pharmaceuticals Announces AMX0035 Demonstrated Statistically Significant Treatment Benefit for People with ALS in the CENTAUR Trial
12/17/2019
Study Meets Primary Endpoint of Slowing of ALS as Measured by the ALSFRS-R
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BioSpace Movers & Shakers, Dec. 13
12/13/2019
Pharma and biotech companies strengthen their leadership teams and boards with this week's hires. -
Amylyx Announces Appointment of Debra Canner as Global Head of Human Resources
12/12/2019
Passionate HR Leader Brings 20+ Years of Experience to Solidify the Growth of the Company’s Team