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Klotho Neurosciences Receives FDA Orphan Drug Designation

Story Highlights
  • Klotho Neurosciences received FDA Orphan Drug Designation for KLTO-202 for ALS treatment.
  • This designation offers incentives and market exclusivity, validating Klotho’s scientific approach.
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Klotho Neurosciences Receives FDA Orphan Drug Designation

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Klotho Neurosciences ( (KLTO) ) has provided an announcement.

On July 10, 2025, Klotho Neurosciences announced that the FDA granted Orphan Drug Designation to its KLTO-202 for the treatment of Amyotrophic Lateral Sclerosis (ALS). This designation provides incentives like tax credits for clinical trials and seven years of market exclusivity. The company’s lead product candidate, KLTO-202, targets motor neuron diseases and muscular dystrophies, aiming to deliver gene therapy to the neuromuscular junction. This FDA recognition is seen as validation of Klotho’s scientific approach and could significantly impact its market positioning in the treatment of rare neurodegenerative diseases.

More about Klotho Neurosciences

Klotho Neurosciences, Inc. is a biogenetics company specializing in the development of innovative cell and gene therapies aimed at treating neurodegenerative and age-related disorders such as ALS, Alzheimer’s, and Parkinson’s disease. The company utilizes a protein derived from a patented form of the human Klotho gene and novel delivery systems to create disease-modifying therapies. Their portfolio includes cell and gene therapy programs using DNA and RNA as therapeutics and genomics-based diagnostic assays.

Average Trading Volume: 43,251,282

Technical Sentiment Signal: Buy

Current Market Cap: $70.62M

Learn more about KLTO stock on TipRanks’ Stock Analysis page.

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