access program – Talk Bio

Cognition Therapeutics Presents Phase 3 Plan for Zervimesine (CT1812) in Alzheimer’s Disease at CTAD Conference

1 month ago talkbio0Tagged access program, Alzheimer 's disease, Clinical Trials, Cognition Therapeutics, CTAD, Lewy bodies, Neurodegenerative Disorders, Phase 3 clinical trial, Presenile dementia, sigma-2 receptor, Zervimesine

Cognition Therapeutics; Zervimesine; CT1812; Phase 3 clinical trial; Alzheimer’s disease; Clinical Trials on Alzheimer’s Disease (CTAD); neurodegenerative diseases; sigma-2 receptor; dementia with Lewy bodies; expanded access program

Ionis Heads to FDA as Antisense Therapy Aces Pivotal Study in Rare Neurological Disease

4 months ago talkbio0Tagged access program, Alexander Disease, Antisense Oligonucleotides, Fast Track, Identifier, Improvement, Infrequent, Ionis Pharmaceuticals, nervous system disorder, orphan drug designation, Phase I – III study, Speed, United States Food and Drug Administration, Zilganersen

Ionis Pharmaceuticals; zilganersen; antisense oligonucleotide; Alexander disease; pivotal Phase I–III study; FDA Fast Track designation; rare neurological disease; expanded access program; walk speed improvement; Orphan Drug designation

Stealth BioTherapeutics Resubmits Third FDA Application for Rare Disease Drug

5 months ago talkbio0Tagged 3-Methylglutaconic aciduria type 2, access program, Drug Approval, Elamipretide, Infrequent, resubmission, Stealth BioTherapeutics, United States Food and Drug Administration

Stealth BioTherapeutics; FDA resubmission; rare disease; Barth syndrome; elamipretide; drug approval; expanded access program