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Heart Failure-Focused scPharmaceuticals Secures FDA Approval For Expanded Use Of Furoscix, Receives Funding To Expand Commercialization

Monday, the FDA approved scPharmaceuticals Inc.’s (NASDAQ:SCPH) Supplemental New Drug Application, seeking to expand the Furoscix indication for heart failure patients. At approval, Furoscix was only indicated for congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure. The new indication now includes patients with NYHA Class IV chronic heart failure, who represent the most symptomatic patients, and those with the greatest limitation on physical activity, comprising approximately 10% of all heart failure patients nationally. scPharmaceuticals also announced non-dilutive financings on Monday of up to $125 million from Perceptive Advisors. Proceeds from the transactions will be used to repay existing debt and fund activities related to the ongoing commercialization of Furoscix. scPharmaceuticals received $75 million through a combination of debt and royalty financings at close, with access to an additional $50 ...