Journal of Neurology

Amylyx Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Financial Results

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星期四, 二月 22, 2024
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, Week, Regulation, Research, Investment, University, Regulation Fair Disclosure, Webcast, CRP, Intellectual property, Progressive supranuclear palsy, Medication, Plasma, ALS, Marketing, Disclosure, AMX0035, Neurosurgery, Publication, Psychiatry, C-reactive protein, Safety, Biomarker, Amylyx Pharmaceuticals, Clinical trial, Survival, Journal of Neurology, Mutation, IND, Wolfram syndrome, PSP, Otsuka Pharmaceutical, Brain cell, Pharmaceutical industry

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today reported financial results for the fourth quarter and full year ended December 31, 2023.
  • Net product revenue for the three months ended December 31, 2023 was $108.4 million, compared to net product revenue of $102.7 million for the three months ended September 30, 2023.
  • Amylyx announced the first patient dosed in the Global Phase 3 ORION Study of AMX0035 in Progressive Supranuclear Palsy (PSP).
  • The first participant was dosed in December 2023, and topline results are anticipated in 2025 or 2026.

Amylyx Pharmaceuticals Announces Publication of Data Showing the Effect of AMX0035 on Plasma Neuroinflammatory Biomarkers in ALS

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星期一, 十二月 4, 2023
Health, Genetics, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Amylyx Pharmaceuticals, Barrow Neurological Institute, CRP, Chitinase, ALS, Plasma, Disease, Journal, Week, Psychiatry, Survival, Journal of Neurology, AMX0035, Doctor of Philosophy, Biomarker, C-reactive protein, Cerebrospinal fluid, Medication, Neurosurgery, HIV disease progression rates, ITT, Medical imaging, Neurology, PHOENIX

Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the publication of analyses performed on neuroinflammatory biomarkers using plasma samples from participants with amyotrophic lateral sclerosis (ALS) from the Phase 2 CENTAUR trial.

Key Points: 
  • Amylyx Pharmaceuticals, Inc. (Nasdaq: AMLX) (“Amylyx” or the “Company”) today announced the publication of analyses performed on neuroinflammatory biomarkers using plasma samples from participants with amyotrophic lateral sclerosis (ALS) from the Phase 2 CENTAUR trial.
  • During the CENTAUR trial, plasma samples were prospectively collected from trial participants for future biomarker analyses.
  • “Neuroinflammatory biomarkers are important for assessing disease progression and therapeutic response in ALS with chitinases and CRP emerging as potential treatment response biomarkers.
  • Further analyses of neuroinflammatory biomarkers are planned in the ongoing Phase 3 PHOENIX trial to confirm these results.

Amylyx Pharmaceuticals Announces Publication of Data Showing Randomization to AMX0035 Prolonged Tracheostomy/Ventilation-free Survival and Reduced Occurrence of First Hospitalization

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星期一, 五月 16, 2022
Health, Other Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, ACT, UPR, Disease, OLE, U.S. Securities and Exchange Commission, Review, Tracheotomy, Psychiatry, Respiration, PM&R, ALS Functional Rating Scale - Revised, Private Securities Litigation Reform Act, Twitter, SEC, Neurosurgery, PM, Massachusetts General Hospital, Journal, Hospital, Endoplasmic reticulum, Mass, Cell death, Unfolded protein response, Associate, COVID-19, Neurodegeneration, PB, Harvard Medical School, Death, Survival, Leandro, Risk, HR, Medical journal, ALS Association, Journal of Neurology, Association, Amyotrophic lateral sclerosis, FDA, Time, Program, Apoptosis, LinkedIn, Spaulding Rehabilitation Hospital, ALS, Population, PAV, Nasdaq, CI, Muscle, Breathe Me, Ventilation, Medication, Pharmaceutical industry, Risk management, Neurology, PHOENIX

Risk of death or tracheostomy/PAV was 49% lower in the group originally randomized to AMX0035 treatment (HR, 0.51; 95% CI, 0.320.84; P=.007).

Key Points: 
  • Risk of death or tracheostomy/PAV was 49% lower in the group originally randomized to AMX0035 treatment (HR, 0.51; 95% CI, 0.320.84; P=.007).
  • Risk of first hospitalization was 44% lower in those originally randomized to the AMX0035 group (HR, 0.56; 95% CI, 0.340.95; P=.03).
  • Amylyx Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company working on developing a novel therapeutic for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases.
  • All forward-looking statements contained in this press release speak only as of the date on which they were made.