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With Tofersen, a first effective treatment is becoming available for ALS!
After decades of repeatedly negative clinical trial results, more than hope is emerging for ALS patients. Indeed, data from the VALOR study, a phase III clinical trial of tofersen in… More >>
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Amylyx Pharmaceuticals Announces FDA Advisory Committee Supports Approval of AMX0035 for the Treatment of ALS
– FDA Advisory Committee voted 7:2 that the available evidence of effectiveness is sufficient to support approval of AMX0035 for the treatment of ALS – If approved, AMX0035 will be the… More >>
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AB Science announces filing of marketing authorization application for Alsitek in the treatment of amyotrophic lateral sclerosis (ALS) and its validation by the European Medicines Agency (EMA)
AB Science announced that it has filed an application for conditional Marketing Authorization to the European Medicines Agency (EMA) for Alsitek (masitinib) in the treatment of amyotrophic lateral sclerosis (ALS).… More >>
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Biogen ALS Community Statement on FDA acceptance new drug application for Tofersen
Dear ALS Community, We are writing to let you know that Biogen announced that the U.S. Food and Drug Administration (FDA) has accepted Biogen’s New Drug Application for tofersen, an investigational drug… More >>
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Cytokinetics Announces Start of Open-Label Extension Study for Patients Completing COURAGE-ALS
Managed Access Program for People Who Have Completed Prior Cytokinetics ALS Trials to Begin in 2H 2022 Cytokinetics announced the start of COURAGE-ALS OLE (Clinical Outcomes Using Reldesemtiv on ALSFRS-R… More >>
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Amylyx announces that Health Canada has approved ALBRIOZA™ (also known as AMX0035), with conditions, for the treatment of ALS
Today Amylyx announced that Health Canada has approved ALBRIOZA™ (sodium phenylbutyrate and ursodoxicoltaurine), with conditions, for the treatment of amyotrophic lateral sclerosis (ALS). Clinical data demonstrated a statistically significant and… More >>
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New 12-Month Tofersen Data Show Clinically Meaningful Benefit in People With SOD1-ALS
• 12-month data show that earlier initiation of tofersen slowed decline across measures of clinical and respiratory function, strength, and quality of life • Tofersen also led to robust and sustained reductions… More >>
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Tranquis Therapeutics Announces Successful Completion of Phase 1 Clinical Trial of TQS-168
TQS-168 was well tolerated and demonstrated excellent pharmacokinetic properties Tranquis plans to start a Phase 2 trial in ALS by the end of 2022 Tranquis Therapeutics, a clinical stage immuno-neurology… More >>

