U.S. Food and Drug Administration issues Complete Response Letter for the glepaglutide New Drug Application for the treatment of short bowel syndrome
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The FDA has issued a Complete Response Letter to Zealand Pharma for their New Drug Application for glepaglutide, indicating that the application did not meet the necessary requirements for efficacy and safety.
December 19, 2024 | 8:15 pm
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Zealand Pharma received a Complete Response Letter from the FDA for their glepaglutide application, indicating unmet requirements for efficacy and safety.
The FDA's Complete Response Letter suggests that Zealand Pharma's glepaglutide did not meet the necessary standards for approval, which is likely to negatively impact the stock price in the short term due to the setback in drug approval.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100