scPharmaceuticals Announces Filing Acceptance Of sNDA From The FDA Seeking To Expand FUROSCIX Indication To Include Chronic Kidney Disease
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scPharmaceuticals Inc. (NASDAQ:SCPH) announced that the FDA has accepted its Supplemental New Drug Application (sNDA) to expand the indication of FUROSCIX to include treatment of edema in patients with chronic kidney disease (CKD). The FDA has set a target action date of March 6, 2025, and no additional clinical studies are required.
July 25, 2024 | 12:16 pm
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scPharmaceuticals Inc. (NASDAQ:SCPH) has received FDA acceptance for its sNDA to expand FUROSCIX's indication to include CKD treatment. The FDA has set a target action date of March 6, 2025, and no additional clinical studies are required.
The FDA's acceptance of the sNDA is a significant regulatory milestone for SCPH, potentially expanding the market for FUROSCIX. The lack of requirement for additional clinical studies reduces development risk and costs, likely leading to a positive short-term impact on SCPH's stock price.
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