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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 >>
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Biogen and Alcyone Therapeutics Announce License and Collaboration Agreement to Evaluate a Novel Device to Improve Patient Experience and Access to Neurological ASO Therapies
Alcyone’s ThecaFlex DRx™ System is an implantable medical device in development for intrathecal drug delivery Biogen and Alcyone Therapeutics have entered into a license and collaboration agreement to develop Alcyone’s… More >>
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European Medicines Agency Accepts Tofersen Marketing Authorization Application to Treat Rare, Genetic Form of ALS
• SOD1-ALS is a rare, genetic form of ALS,1 comprising approximately 2% of people with ALS2 • If approved, tofersen would be the first treatment to target a genetic cause of ALS Biogen… More >>
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TRICALS statement on FDA approval of Amylyx AMX0035
During a meeting of the FDA’S Peripheral and Central Nervous System Drugs Advisory Committee (PCNSDAC) on Thursday September 29 2022, the Amylyx drug AMX0035 received conditional approval under the name… More >>
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Amylyx Pharmaceuticals Announces FDA Approval of RELYVRIO™ for the Treatment of ALS
• RELYVRIO (previously known as AMX0035 in the U.S.) is an oral, fixed-dose combination therapy for the treatment of adults with ALS • RELYVRIO significantly slowed loss of physical function in a… More >>
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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 >>
