Articles by Kelly Lyons

Amylyx Pharmaceuticals Provides Global Regulatory Update on AMX0035 for ALS April 14, 2021

– 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 developing new treatments for amyotrophic lateral sclerosis (ALS), Alzheimer’s Disease and other neurodegenerative diseases, today provided an update on its plans to advance AMX0035 through the clinical development process for the treatment of ALS. The company intends to submit a Marketing Authorization Application (MAA) for AMX0035 to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) by the end of 2021. As previously reported, the company plans to submit a marketing application with Health Canada Q2 2021. The FDA has expressed an interest in seeing data from an additional placebo-controlled clinical trial prior to receiving a New Drug Application (NDA), the vehicle through which a pharmaceutical

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Amylyx Pharmaceuticals to Present CENTAUR Long-Term Survival Data of AMX0035 for ALS in Plenary Session at 2021 Virtual American Academy of Neurology (AAN) Annual Meeting April 13, 2021

– 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 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 long-term survival data from the CENTAUR trial of AMX0035 in patients with ALS were selected for an oral presentation in the Contemporary Clinical Issues Plenary Session on April 19 at the 2021 American Academy of Neurology (AAN) Annual Meeting. The meeting is being held virtually on April 17-22. The abstract, “Long-Term Survival of Participants in the CENTAUR Trial of AMX0035 for ALS,” was one of 26 abstracts awarded the merit of distinction by the American Academy of Neurology and the Science Committee. The distinction is awarded to the abstract deemed

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Paul Fonteyne Joins Amylyx Pharmaceuticals Board of Directors March 29, 2021

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 for amyotrophic lateral sclerosis (ALS), Alzheimer’s disease and other neurodegenerative diseases, today announced the appointment of Paul Fonteyne to its Board of Directors. Mr. Fonteyne’s deep commercialization and leadership experience will support the company’s global plans to bring new treatments to people with neurodegenerative diseases. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210329005384/en/ Paul Fonteyne, Amylyx Board of Directors member (Photo: Business Wire) “Paul is a true leader in the health care industry with a proven record of success in building effective teams, launching global products and running commercial organizations focused on delivering for

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Amylyx Pharmaceuticals to Present New Long-Term Data from the Pivotal CENTAUR Trial in ALS at the Muscular Dystrophy Association (MDA) Virtual Clinical & Scientific Conference March 18, 2021

– 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 Statistically Significant Slowing of Functional Decline and Long-Term Survival Results Associated with the Administration of AMX0035 CAMBRIDGE, Mass. […]

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Amylyx Pharmaceuticals Plans Regulatory Filing of AMX0035 for the Treatment of ALS in Canada March 9, 2021

– 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 amyotrophic lateral sclerosis (ALS), Alzheimer’s Disease and other neurodegenerative diseases, today announced plans to submit a New Drug Submission (NDS) for AMX0035 for the treatment of ALS with Health Canada in the first half of 2021. The decision to submit is based on the positive clinical data from the CENTAUR trial and feedback from Health Canada. In addition, Amylyx will explore options for early access to AMX0035 in Canada, including a potential special access program (SAP) in collaboration with the Canadian ALS Research Network, and aims to finalize plans by the end of the second quarter of 2021. “Results from CENTAUR demonstrated that AMX0035 has both functional and long-term survival benefits which were seen on top of baseline use of

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Amylyx Pharmaceuticals Appoints Erin Whitney Head of Global Clinical Operations, Shauna Horvath Head of Global Marketing and Keith White Head of Global Market Access December 21, 2020

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 diseases, today announced the appointments of Erin Whitney to Head of Global Clinical Operations, Shauna Horvath, previously a brand strategy consultant to Amylyx, to Head of Global Marketing and Keith White to Head of Global Market Access. These key additions to the Amylyx team are integral to support the company’s continued growth and future commercialization plans. “We are thrilled to have these highly skilled leaders join the Amylyx team at this critical time of growth as we continue our efforts to advance the development of AMX0035, our investigational product, in multiple neurodegenerative diseases,” said Joshua Cohen, Co-CEO, Chairman and Co-Founder of Amylyx. “Erin’s deep experience in complex clinical

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Amylyx Pharmaceuticals to Present Positive Functional and Survival Data and New Predictive Modeling Results from the CENTAUR Trial in People with ALS at the 31st International Symposium on ALS/MND December 9, 2020

– 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 from AMX0035 Use Compared to Predicted 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 the presentation of results from the CENTAUR and open-label extension (OLE) trials demonstrating positive results from administration of AMX0035 in the retention of functional abilities and survival for people with ALS at the 31 st International Symposium on ALS/MND. CENTAUR was a 24-week placebo-controlled study of 137 participants with ALS that evaluated the safety and efficacy of AMX0035. The study was led by Drs. Sabrina Paganoni and Merit Cudkowicz from the Healey Center for

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Amylyx Pharmaceuticals Announces FDA Granted Orphan Drug Designation for AMX0035 for the Treatment of Wolfram Syndrome November 16, 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 that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to AMX0035 for the treatment of Wolfram syndrome. “There is a critical unmet need for people living with Wolfram syndrome, a rare genetic disease in which many patients die prematurely with severe neurological disabilities,” said Wolfram syndrome expert Fumihiko Urano, M.D., Ph.D., a Professor of Medicine and of Pathology and Immunology at Washington University School of Medicine in St. Louis. “Endoplasmic reticulum (ER) dysfunction is a critical component of Wolfram syndrome. AMX0035 is designed to target the ER stress, and preclinical data suggest that it may be a promising approach to halt the irreversible progression of optic nerve atrophy in patients with Wolfram syndrome.” The FDA may grant

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Amylyx Pharmaceuticals Announces Last Patient Completes Final Study Visit in PEGASUS Trial of AMX0035 in Alzheimer’s Disease November 9, 2020

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 last participant has completed the planned 24 weeks in the Phase II PEGASUS trial assessing the safety and biological activity of AMX0035 administration in people with Alzheimer’s disease. “Alzheimer’s is a complex, progressive brain disease defined by amyloid and tau pathologies, but we now realize that there are multiple pathways driving the disease,” said Steven E. Arnold, M.D., Professor and Translational Neurology Head of the Interdisciplinary Brain Center at Massachusetts General Hospital and Harvard Medical School and the PEGASUS trial principal investigator. “The PEGASUS trial design and broad inclusion criteria will allow us to assess whether AMX0035 can prevent neurodegeneration in people with Alzheimer’s via MR

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Fierce Biotech Names Amylyx Pharmaceuticals as One of Its “Fierce 15” Biotech Companies of 2020 September 28, 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 that it has been named by Fierce Biotech as one of 2020’s Fierce 15 biotechnology companies, designating Amylyx as one of the most promising private biotechnology companies in the industry. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200928005617/en/ The 2020 Fierce 15 comes at a time when the world is focused on a pandemic, but even as coronavirus remains a threat, patients with cancer, rare diseases and other disorders still need treatment, Fierce Biotech Senior Editor Ben Adams said. “This year, we’ve chosen from a diverse range of those fighting COVID, as well as those fighting longer term plagues against our biology,” Adams said. Amylyx’ lead product candidate, AMX0035, is an investigational neuroprotective

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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 September 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, Breathing, and Hospitalizations – AMX0035 Was Generally Well Tolerated with Similar Rates of Adverse Events Recorded in the AMX0035 and Placebo Groups 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 the publication of results from the pivotal CENTAUR trial evaluating AMX0035 – an investigational neuroprotective therapy designed to reduce the death and dysfunction of motor neurons – in people with

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Tammy Sarnelli Joins Amylyx Pharmaceuticals as Global Head of Regulatory Affairs August 25, 2020

Former Biogen and EMD Serono Executive with Broad Experience in the Neurology and Rare Disease Space Bolsters Growing Amylyx Executive Leadership Team 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 Tammy Sarnelli as Global Head of Regulatory Affairs. Tammy Sarnelli brings more than 30 years of experience in the pharmaceutical industry, with regulatory expertise in early and late stage of neurology and rare disease drug development. In this role, she will oversee regulatory submissions, strategy, and compliance. “We are confident that Tammy’s experience will provide invaluable guidance in advancing our clinical ALS and Alzheimer’s disease programs as we work toward significant regulatory milestones this year and moving forward,” said Justin Klee, Co-Founder and Co-CEO of Amylyx. “I look forward to having Tammy play an integral

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Amylyx Pharmaceuticals Raises $30 Million in Series B Funding July 1, 2020

– Proceeds enable continued investment in lead product candidate AMX0035 in ALS and Alzheimer’s disease – Amylyx has closed more than $45M in financing in 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 million Series B financing, led by Morningside Ventures, with participation from other investors. “The results AMX0035 achieved for ALS patients in the CENTAUR trial paired with Amylyx’ strong partnerships in the ALS and Alzheimer’s communities give credence to continued success,” said Isaac Cheng, M.D., of Morningside Ventures. “By targeting mitochondrial and endoplasmic reticulum dependent neuronal degeneration pathways, Amylyx can have a very significant impact for patients suffering from neurodegenerative diseases, a critical threat to global public health.” “We share Morningside’s

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Amylyx Pharmaceuticals Announces Completion of Enrollment in the PEGASUS Trial of AMX0035 in Alzheimer’s Disease June 15, 2020

– Amylyx Remains on Track to Share Topline PEGASUS Trial Results by Q1 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 it has completed enrollment in the Phase II PEGASUS trial assessing AMX0035 in individuals with Alzheimer’s disease. Amylyx completed enrollment, dosing 96 of the previously planned 100 participants. The PEGASUS trial will provide data on the safety and tolerability profile of AMX0035 in people living with Alzheimer’s disease, biological activity on biomarkers related to disease processes and preliminary information on cognitive and functional effects of AMX0035. Trial collaborators include the Alzheimer’s Association, the Alzheimer’s Drug Discovery Foundation (ADDF) and Cure Alzheimer’s Fund. In April 2019, Amylyx doubled the PEGASUS trial’s planned enrollment to approximately 100 participants with

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Machelle Manuel, Ph.D., Joins Amylyx Pharmaceuticals as Vice President, Head of Global Medical Affairs May 11, 2020

New Vice President of Medical Affairs Brings 20+ Years of Experience to Growing Leadership Team 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 experience in medical scientific affairs in the pharmaceutical industry. “It is our great pleasure to welcome Dr. Manuel to Amylyx as we continue our quest to end suffering caused by neurodegenerative diseases,” said Patrick Yeramian, M.D., MBA, Chief Medical Officer at Amylyx Pharmaceuticals. “Machelle brings an impressive and unique skillset and leadership qualities that will further poise Amylyx to grow from a clinical- to commercial-stage company.” Previously, Dr. Manuel spent eight years at Ironwood Pharmaceuticals, where she was head of global medical scientific affairs

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Get the latest news and updates from Amylyx, delivered right to your inbox.

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