KORU Medical Systems Signs Supply Agreement For Phase III Clinical Trial For A Novel Enzyme Replacement Therapy To Treat A Rare Endocrinological Disease
Portfolio Pulse from Benzinga Newsdesk
KORU Medical Systems, Inc. (KRMD) has signed a Phase III clinical supply agreement for a novel enzyme replacement therapy aimed at treating a rare endocrinological disease. This marks a significant milestone in the collaboration announced in July 2023, with the KORU Medical Freedom System passing validation testing for subcutaneous infusion administration of the drug. The Phase III trial will evaluate bi-weekly infusions using the Freedom System. The drug has received Breakthrough Therapy, Rare Pediatric Disease, and Fast Track designations by the FDA, along with Orphan Drug designation in the US and Europe.
May 14, 2024 | 8:22 pm
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KORU Medical's signing of a Phase III clinical supply agreement for a novel enzyme replacement therapy represents a significant advancement in its pipeline, potentially positioning the company as a leader in treatments for rare diseases. The successful validation of the KORU Medical Freedom System for this drug's administration and the drug's receipt of multiple FDA designations highlight its potential impact and the company's capability in developing innovative treatment solutions.
The agreement for a Phase III trial and the successful validation of the Freedom System for drug administration are strong indicators of KORU Medical's progress in its development pipeline. The FDA designations suggest a high potential for regulatory success and market exclusivity, which could significantly impact KRMD's stock in the short term by increasing investor confidence and potentially leading to an increase in stock price.
CONFIDENCE 85
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RELEVANCE 100