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Monday, the FDA approved scPharmaceuticals Inc.’s SCPH Supplemental New Drug Application, seeking to expand the Furoscix indication for heart failure patients.
周一,FDA批准了scPharmaceuticals Inc.的SCPH补充新药申请,试图扩大Furoscix对心力衰竭患者的适应症。
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.
经批准,Furoscix仅适用于纽约心脏协会(NYHA)II级和III级慢性心力衰竭成年患者因液体超负荷引起的充血。
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.
新的适应症现在包括NYHA IV级慢性心力衰竭患者,他们代表了症状最严重的患者,以及体力活动受到最大限制的患者,约占全国所有心力衰竭患者的10%。
scPharmaceuticals also announced non-dilutive financings on Monday of up to $125 million from Perceptive Advisors.
scPharmaceuticals周一还宣布,敏锐的顾问将提供高达1.25亿美元的非稀释性融资。
Proceeds from the transactions will be used to repay existing debt and fund activities related to the ongoing commercialization of Furoscix.
交易收益将用于偿还现有债务,并为与Furoscix持续商业化相关的活动提供资金。
scPharmaceuticals received $75 million through a combination of debt and royalty financings at close, with access to an additional $50 million.
scPharmaceuticals在收盘时通过债务和版税融资获得了7500万美元,另外获得了5000万美元。
The term loan refinances existing debt principal, lowers coupon, extends the interest-only period for four additional years, and lowers the minimum cash requirement to $5 million.
定期贷款对现有债务本金进行再融资,降低息票,将仅计息期延长四年,并将最低现金要求降低至500万美元。