Articles by Radu Cocian

Amylyx Pharmaceuticals Gets #INKEDforALS May 4, 2020

Company Launches #INKEDforALS Campaign in its Commitment to Raising Awareness for the ALS Community During ALS Awareness Month Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, today is honored to support ALS Awareness Month 2020 with the launch of “#INKEDforALS”, a campaign that aims to raise awareness for ALS. The campaign will serve as a platform to bring people together to educate and encourage conversation about ALS and celebrate the efforts of the caregivers and physicians who are fighting alongside people with ALS. In support of this year’s ALS Awareness Month, Amylyx created a temporary tattoo to raise awareness and funds, spark conversation about ALS and rally this resilient community together to help fight the disease. To help take action alongside this effort, Amylyx is encouraging the community to: Order a temporary tattoo from www.INKEDforALS.com Apply

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European Medicines Agency Grants Orphan Drug Designation to Amylyx Pharmaceuticals’ AMX0035 for the Treatment of Amyotrophic Lateral Sclerosis (ALS) April 29, 2020

Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has recommended that AMX0035 be designated as an orphan medicinal product for the treatment of ALS. AMX0035 is an investigational, first-in-class, disease-modifying therapy designed to reduce neuronal death and dysfunction. The EMA grants Orphan Drug Designation status for products intended for the treatment, prevention or diagnosis of rare, life-threatening or chronically debilitating conditions where the product may represent a significant benefit over existing treatments. “ALS patients worldwide are in need of new therapies,” said Joshua Cohen, Co-CEO, Chairman, and Co-Founder of Amylyx, “We’re excited about today’s news and look forward to working with the European Medicines Agency on the next steps for

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Amylyx Pharmaceuticals Announces AMX0035 Demonstrated Statistically Significant Treatment Benefit for People with ALS in the CENTAUR Trial December 17, 2019

Study Meets Primary Endpoint of Slowing of ALS as Measured by the ALSFRS-R Amylyx Pharmaceuticals, Inc., a pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, and the Sean M. Healey & AMG Center for ALS at Mass General today announced that AMX0035 demonstrated a significant treatment benefit for people with ALS in the CENTAUR study. In the study, participants taking AMX0035 had a statistically significant slowing of ALS disease progression as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R) compared to placebo (p<0.05), the primary outcome of the trial. “We will work closely with the FDA and the ALS community, including the wonderful Northeast ALS Consortium leadership and member sites that conducted the CENTAUR trial, to decide next steps and will continue to keep everyone informed.”Tweet this Detailed results from CENTAUR will be submitted for peer-reviewed publication and

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Amylyx Announces Appointment of Debra Canner as Global Head of Human Resources December 12, 2019

Passionate HR Leader Brings 20+ Years of Experience to Solidify the Growth of the Company’s Team CAMBRIDGE, Mass. (BUSINESS WIRE) –Amylyx Pharmaceuticals, Inc., today announced the appointment of Debra Canner as the company’s first Global Head of Human Resources. Deb will serve on Amylyx’ Executive Team, overseeing the company’s human resource efforts, including talent management, organizational leadership, culture and corporate responsibility. Throughout her distinguished career as a human resources leader, including chief human resources officer experience at three preeminent life science and technology organizations, Deb brings a strategic yet practical approach to her work.Deb will play a large role in shaping and fostering a culture focused on attracting, retaining and developing bold, collaborative talent that aims to improve the lives those of suffering from disease. “We’re thrilled Deb has joined us to continue building a strong core team that is eager to dedicate themselves

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Amylyx Pharmaceuticals Announces Last Patient Completes Last Study Visit in CENTAUR Phase 2 Study of AMX0035 in ALS October 4, 2019

CAMBRIDGE, Mass.  ( BUSINESS WIRE) –Amylyx Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing new treatments for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, today announced that the last participant has completed the planned 24 weeks of study treatment in CENTAUR, a clinical trial assessing the safety and efficacy of AMX0035 in people with ALS. “This trial has been an important partnership between industry and academia, and we look forward to analyzing the results gathered in this study,” said the study Principal Investigator Dr. Sabrina Paganoni, investigator at the Healey Center for ALS at Mass General and Assistant Professor of PM&R at Harvard Medical School and Spaulding Rehabilitation Hospital. “Thank you to the participants and site study teams who have made this work possible.” The CENTAUR study was the recipient of the ALS ACT grant, and is supported by  ALS Finding a Cure® ,-a program of The Leandro

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Amylyx Pharmaceuticals Strengthens Leadership Team with the Appointments of Chief Medical Officer, Chief Commercial Officer and Global Head, Supply Chain June 24, 2019

CAMBRIDGE, MA  ( BUSINESS WIRE ) — Amylyx Pharmaceuticals, Inc., today announced three additions to its executive leadership team, appointing industry veterans Patrick Yeramian, M.D., MBA, as chief medical officer, Margaret Olinger, MBA, as chief commercial officer and Tom Holmes as global head, supply chain. These three key appointments serve to build and direct the company’s clinical development and commercial strategies. “We are thrilled to welcome Patrick, Margaret and Tom to the Amylyx team, with their decades of experience spanning clinical development all the way through launch and commercialization,” said Joshua Cohen, chief executive officer and co-founder of Amylyx. “With two Phase II clinical trials underway, expanding our leadership team helps us progress toward our mission to bring new therapeutic options rapidly to the people suffering from neurodegenerative diseases.” Dr. Yeramian brings more than 30 years of pharmaceutical industry experience to Amylyx. Prior to

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Amylyx Pharmaceuticals Announces First Patients Dosed in PEGASUS Phase 2 Trial of AMX0035 in Alzheimer’s Disease and Expansion of the Trial April 3, 2019

CAMBRIDGE, MA  ( BUSINESS WIRE ) — Amylyx Pharmaceuticals, Inc., in collaboration with the Alzheimer’s Association, the Alzheimer’s Drug Discovery Foundation (ADDF) and the Cure Alzheimer’s Fund, today announced the dosing of its first patients in a recently expanded Phase 2 clinical trial (PEGASUS) to assess AMX0035 in individuals with Alzheimer’s disease. AMX0035 is Amylyx’s proprietary two-drug combination therapy in development to prevent nerve cell death and degeneration. “The urgent need for a new approach to Alzheimer’s is clearer now than ever. As this is one of the first major combination therapy clinical trials for Alzheimer’s Disease, we’re optimistic about AMX0035’s potential to slow disease progression in individuals through its novel mechanisms of action,” said Steven E. Arnold, M.D., Translational Neurology Head of the Interdisciplinary Brain Center at Massachusetts General Hospital and Harvard Medical School and the study’s principal investigator. Alzheimer’s

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Innovative Alzheimer’s Disease Combination Therapy Trial Supported By New Joint Funding Initiative October 24, 2017

NEW YORK AND CHICAGO, Oct. 24, 2017 /PRNewswire-USNewswire/ — The Alzheimer’s Association and Alzheimer’s Drug Discovery Foundation (ADDF) are collaborating to jointly fund a new combination therapy clinical trial for Alzheimer’s disease to be conducted by Amylyx Pharmaceuticals. The $1.85 million grant is the first award under an initiative created by the Alzheimer’s Association and the ADDF to fund combination therapies. The grant will support a phase 2 clinical trial of AMX0035, a combination of sodium phenylbutyrate (PB) and tauroursodeoxycholic-acid (TUDCA). The trial, expected to begin in the first half of 2018, will include approximately 50 people with mild cognitive impairment or mild-to-moderate Alzheimer’s disease and test the drug’s effectiveness at slowing or stopping brain cell death. “Combination therapies hold great potential to slow the progression of Alzheimer’s,” said Howard Fillit, MD, the ADDF’s founding executive director

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Amylyx Pharmaceuticals Receives FDA Orphan Drug Designation for AMX0035 for the Treatment of Amyotrophic Lateral Sclerosis September 19, 2017

October 24, 2017 08:00 AM Eastern Daylight Time NEW YORK AND CHICAGO, Oct. 24, 2017 /PRNewswire-USNewswire/ — The Alzheimer’s Association and Alzheimer’s Drug Discovery Foundation (ADDF) are collaborating to jointly fund a new combination therapy clinical trial for Alzheimer’s disease to be conducted by Amylyx Pharmaceuticals. The $1.85 million grant is the first award under an initiative created by the Alzheimer’s Association and the ADDF to fund combination therapies. The grant will support a phase 2 clinical trial of AMX0035, a combination of sodium phenylbutyrate (PB) and tauroursodeoxycholic-acid (TUDCA). The trial, expected to begin in the first half of 2018, will include approximately 50 people with mild cognitive impairment or mild-to-moderate Alzheimer’s disease and test the drug’s effectiveness at slowing or stopping brain cell death. “Combination therapies hold great potential to slow the progression of Alzheimer’s,” said Howard

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Project ALS and Amylyx Enter Collaboration to Test AMX0035 September 7, 2017

Pre-clinical studies at Columbia University’s Motor Neuron Center Complement Amylyx Phase 2 Clinical Studies of Lead Therapeutic Compound New York, NY and Cambridge, MA (September 7, 2017) – Project ALS and Amylyx Pharmaceuticals today announced a collaboration to undertake pre-clinical studies with Amylyx’s oral compound AMX0035 to advance the understanding of the compound’s neurobiological effects. The studies to be conducted at the Project ALS Pre-Clinical Core at Columbia University’s Motor Neuron Center will complement the company’s recently initiated Phase 2 clinical program of AMX0035 for the treatment of amyotrophic lateral sclerosis (ALS). The Project ALS Pre-Clinical Core at the Columbia University’s Motor Neuron Center has established a unique integrated and standardized platform for the testing and validation of new therapeutic strategies in recognized experimental models of ALS and for biomarker discovery. The Core, developed in collaboration with Project ALS, will

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