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TRICALS Enrols First Participants in Phase 3 MAGNET platform trial for ALS
TRICALS (the Treatment Research Initiative to Cure ALS), in collaboration with ALS associations and funding agencies from Europe and Australia, has launched its clinical platform trial for amyotrophic lateral sclerosis… More >>
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UCB Zilucoplan trial arm stopped early in HEALEY ALS Platform
The independent Data and Safety Monitoring Board (DSMB) recommended stopping the zilucoplan regimen in the HEALEY ALS Platform Trial after a pre-scheduled interim analysis demonstrated futility. The Healey ALS Platform… More >>
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Amylyx Pharmaceuticals Announces EMA Validation of Marketing Authorisation Application (MAA) for AMX0035 for the Treatment of ALS
Amylyx Pharmaceuticals announced that its Marketing Authorisation Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for AMX0035 (sodium phenylbutyrate [PB] and ursodoxicoltaurine [TURSO;… More >>
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Amylyx Pharmaceuticals Submits Marketing Authorization Application (MAA) for AMX0035 for the Treatment of ALS
CAMBRIDGE, Mass. – Amylyx Pharmaceuticals, Inc. today announced it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP)… More >>
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Biogen Announces Topline Results from the Tofersen Phase 3 Study and its Open-Label Extension in SOD1-ALS
CAMBRIDGE, Mass., Oct. 17, 2021 (GLOBE NEWSWIRE) — Biogen Inc. (Nasdaq: BIIB) today announced topline results from its pivotal Phase 3 VALOR study of tofersen (BIIB067), an investigational antisense drug… More >>
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Amylyx Pharmaceuticals Announces Plan to Submit New Drug Application (NDA) for AMX0035 for the Treatment of ALS in the Coming Months
Amylyx Pharmaceuticals announced its intention to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for AMX0035 (sodium phenylbutyrate (PB) and taurursodiol (TURSO)) for the… More >>
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Alexion announces stop of Ultomiris CHAMPION-ALS Phase 3 trial
Dear ALS Community, Today, we are sharing the disappointing news that we have made the difficult decision to discontinue the CHAMPION-ALS Phase III trial, based on the recommendation of the… More >>
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Cytokinetics Announces Start of COURAGE-ALS, a Phase 3 Clinical Trial of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis
Pivotal Trial Builds on Results from FORTITUDE-ALS which Demonstrated Slowing of Decline of SVC and ALSFRS-R in Patients on Reldesemtiv Compared to Placebo Company Is Planning to Provide Continued Access… More >>

