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Ferrer extends its clinical study in ALS
With the aim of making a positive impact in society, Ferrer has started the extension of its phase III clinical trial ADORE (ALS trial with Daily ORal Edaravone), with FNP122… More >>
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Amylyx Pharmaceuticals Provides Update on Ongoing Regulatory Review of AMX0035 for the Treatment of ALS
Amylyx announced an update on the ongoing review of its Marketing Authorisation Application (MAA) for AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine [also known as taurursodiol]) for the treatment of adults with… More >>
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Wave discontinues FOCUS-C9 trial
Dear ALS and FTD Communities, We are sharing this update to keep you informed of Wave Life Sciences’ FOCUS-C9 and FOCUS-C9 open label extension studies, which are Phase 1b/2a clinical… More >>
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FDA Grants Accelerated Approval for QALSODY™ (tofersen) for SOD1-ALS, a Major Scientific Advancement as the First Treatment to Target a Genetic Cause of ALS
• FDA granted accelerated approval of QALSODY based on a reduction of neurofilament, a marker of neurodegeneration • Superoxide dismutase 1 (SOD1)-amyotrophic lateral sclerosis (ALS) is a devastating, uniformly fatal, and ultra-rare… More >>
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Apellis announces discontinuation open-label period MERIDIAN study
Apellis announced that people living with ALS will discontinue investigational treatment with systemic pegcetacoplan in the open-label period of the MERIDIAN study. The decision was made following an unblinded review… More >>
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Cytokinetics discontinues COURAGE-ALS clinical trial of Reldesemtiv
Cytokinetics announces COURAGE-ALS met criteria for futility at second interim analysis Company Plans to Discontinue the Phase 3 Clinical Trial of Reldesemtiv After Data Monitoring Committee Found No Effect on… More >>
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Biogen Provides Update on FDA Advisory Committee Meeting on Tofersen for SOD1-ALS
SOD1-ALS is a rare genetic form of the disease affecting approximately 330 people in the United States Biogen announced today the outcome of the U.S. Food and Drug Administration’s (FDA)… More >>
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Amylyx announces completion of enrollment on Phase 3 PHOENIX trial of AMX0035 in ALS
Topline results expected in 2024 Amylyx Pharmaceuticals announced the completion of enrollment in PHOENIX, aglobal, 48-week, randomized, placebo-controlled Phase 3 clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known… More >>

