ALS Research news

September 5, 2024 - Decoding regulatory agency decisions - The case of Amylyx's Relyvrio-Albrioza in the US and EU
May 31, 2024 - Biogen Receives European Commission Approval for QALSODY® (tofersen), the First Therapy to Treat a Rare, Genetic Form of ALS
May 17, 2024 - Biogen and Ionis Announce Topline Phase 1-2 Study Results of Investigational Drug in ALS
April 08, 2024 - Amylyx announces formal intention to Remove RELYVRIO®- ALBRIOZA™ from the market, provides update on access to therapy, and on pipeline
March 27, 2024 - Top line results TUDCA
March 25, 2024 - Ferrer and Verge Genomics Announce Agreement to Co-Develop Clinical-Stage ALS Therapy VRG50635
March 11, 2024 - Amylyx announces topline results from global Phase 3 PHOENIX trial of AMX0035 in ALS
February 21, 2024 - Sanofi Himalaya Update for EUpALS
January 26, 2024 - EMA written submission needed
February 26, 2024 - Biogen Community Statement on Tofersen CHMP Opinion
Januari 29, 2024 - European Union funds groundbreaking research into psychedelic therapy
Januari 23, 2024 - Prilenia Announces Clinical Data in Support of its Plans to Initiate Global Phase 3 Study in ALS
Januari 10, 2024 - Ferrer Phase 3 ADORE trial with FAB122 (oral Edaravone) does not meet primary and secondary endpoints
December 11, 2023 - NeuroSense's Phase 2b ALS Trial Achieves Primary Safety and Tolerability & Secondary Clinical Efficacy Endpoints
October 13, 2023 - EMA CHMP negative opinion for AMX-0035 for treatment of ALS in EU upon re-examination
September 28, 2023 - BrainStorm update on FDA review NurOwn for treatment of ALS
September 7, 2023 - ALS EU Coalition
June 23, 2023 - Amylyx Receives EMA CHMP Negative Opinion on its Conditional Marketing Authorisation Application for AMX0035 for ALS in EU
June 22, 2023 - Ferrer extends its clinical study in ALS
May 30, 2023 - Amylyx Pharmaceuticals Provides Update on Ongoing Regulatory Review of AMX0035 for the Treatment of ALS
May 23, 2023 - Wave discontinues FOCUS-C9 trial
April 26, 2023 - Apellis announces discontinuation open-label period MERIDIAN study
April 26, 2023 - FDA Grants Accelerated Approval for QALSODY™ (tofersen) for SOD1-ALS
April 3, 2023 - Cytokinetics discontinues COURAGE-ALS clinical trial of Reldesemtiv
March 3, 2023 - Biogen Provides Update on FDA Advisory Committee Meeting on Tofersen for SOD1-ALS
February 3, 2023 - Amylyx announces completion of enrollment on Phase 3 PHOENIX trial of AMX0035 in ALS
January 10, 2023 - Biogen and Alcyone Therapeutics collaborate on novel device to improve access to neurological ASO therapies
December 5, 2022 - EMA accepts Biogen Tofersen Marketing Authorization Application
October 7, 2022 - TRICALS statement on FDA approval of Amylyx AMX0035
September 29, 2022 - Amylyx Pharmaceuticals Announces FDA Approval of RELYVRIO™ for the Treatment of ALS
September 22, 2022 - With Tofersen, a first effective treatment is becoming available for ALS!
September 16, 2022 - Amylyx Pharmaceuticals announces FDA Advisory Committee Supports Approval of AMX0035 for the Treatment of ALS’
August 30, 2022 - 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))
July 29, 2022 - Biogen ALS Community Statement on FDA acceptance new drug application for Tofersen
July 4, 2022 - Tranquis Therapeutics Announces Successful Completion of Phase 1 Clinical Trial of TQS-168
June 17, 2022 - Cytokinetics Announces Start of Open-Label Extension Study for Patients Completing COURAGE-ALS
June 14, 2022 - Amylyx announces that Health Canada has approved ALBRIOZA™ (also known as AMX0035), with conditions, for the treatment of ALS
June 7, 2022 - Biogen Tofersen new 12-month data show meaningful benefit in people with SOD1-ALS
May 9, 2022 - Amylyx’ AMX0035 further demonstrates safety profile in ALS
April 5, 2022 - Wave announces positive update to ongoing Phase1b-2a FOCUS-C9 study
March 31, 2022 - Biogen ALS Community Statement on discontinuation BIIB078 trial
March 28, 2022 - Biogen and Ionis Announce Topline Phase 1 Study Results of Investigational Drug in C9orf72 Amyotrophic Lateral Sclerosis
March 15, 2022 - TRICALS MAGNET study with lithium carbonate enrolls first participants
March 2, 2022 - UCB Zilucoplan trial arm stopped early in HEALEY ALS Platform
February 5, 2022 - Amylyx Pharmaceuticals Announces EMA Validation of Marketing Authorisation Application (MAA) for AMX0035 for the Treatment of ALS
Janurary 5, 2022 - Amylyx Pharmaceuticals Submits Marketing Authorization Application (MAA) for AMX0035 for the Treatment of ALS
October 17, 2021 - Biogen Announces Topline Results from the Tofersen Phase 3 Study and its Open-Label Extension in SOD1-ALS
September 15, 2021 - Amylyx Pharmaceuticals announces plan to submit NDA for AMX0035 in the treatment of ALS in the coming months
August 20, 2021 - Alexion announces stop of Ultomiris CHAMPION-ALS Phase 3 trial
August 2, 2021 - Cytokinetics Announces Start of COURAGE-ALS, a Phase 3 Clinical Trial of Reldesemtiv in Patients With Amyotrophic Lateral Sclerosis
June 1, 2021 - AB Science announces voluntary hold in clinical studies with masitinib worldwide
May 7, 2021 - Orphazyme announces topline data from pivotal trial of arimoclomol in Amyotrophic Lateral Sclerosis (ALS)
March 5, 2021 - Notice to SOD1 pALS regarding access to Tofersen Compassionate Use - Early Access Program
April 14, 2021 - AMYLYX PHARMACEUTICALS PROVIDES GLOBAL REGULATORY UPDATE ON AMX0035 FOR ALS