Amyotrophic Lateral Sclerosis emerging drugs
Jul 15, 2025
Nanoscope’s MCO-010 Begins FDA Rolling Submission for Retinitis Pigmentosa; Bayer’s KERENDIA Approved by FDA for Heart Failure With Preserved Ejection Fraction; Klotho Neurosciences’ KLTO-202 Receives FDA Orphan Drug Designation for ALS; Trethera’s TRE-515 Granted FDA Fast Track Designation for Metastatic Prostate Cancer; Adcentrx’s ADRX-0405 Awarded FDA Orphan Drug Designation for Gastric Cancer
Nanoscope Therapeutics Begins FDA Rolling Submission for MCO-010 in Retinitis Pigmentosa Nanoscope Therapeutics has initiated a rolling submission of its Biologics License Application (BLA) to the FDA for MCO-010, a first-in-class, gene-agnostic optogenetic therapy targeting severe vision loss due to retinitis p...
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Jun 10, 2025
Amylyx’s AMX0114 Fast Tracked by FDA for ALS; Cellectar’s Iopofosine I 131 Granted FDA Breakthrough in Waldenstrom Macroglobulinemia; YolTech’s YOLT-101 Clears FDA IND for Familial Hypercholesterolemia; Oncovita’s MVdeltaC Gets FDA Orphan Tag for Pleural Mesothelioma; Merck’s ENFLONSIA Approved for RSV Prevention in Infants
Amylyx Pharmaceuticals Receives FDA Fast Track Designation for AMX0114 in ALS Amylyx Pharmaceuticals announced that the FDA has granted Fast Track designation to its investigational antisense oligonucleotide (ASO), AMX0114, for the treatment of amyotrophic lateral sclerosis (ALS). The candidate targets calpain-2...
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Sep 24, 2024
Unveiling Amyotrophic Lateral Sclerosis (ALS) Treatment Frontiers: Navigating Challenges, Overcoming Setbacks, and Emerging Therapeutic Horizons
DelveInsight forecasts that with the launch of 15+ emerging therapies alongside existing treatments, the ALS treatment market is anticipated to surpass USD 4 billion across the 7MM by 2034. Currently, there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease. As per ou...
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Sep 24, 2024
Amyotrophic Lateral Sclerosis Treatment: The Journey of Radicava and Highlights of Riluzole Formulations
Amyotrophic Lateral Sclerosis (ALS) or Lou Gehrig’s disease is a rare, progressive, and fatal neuromuscular disease characterized by degeneration of upper and lower motor neurons. While it is associated with a mortality rate of 50% within 30 months of Amyotrophic Lateral Sclerosis symptoms onset, there is still no ...
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