BURLINGTON, Mass. - scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing its Supplemental New Drug Application (sNDA) for the FUROSCIX drug. The sNDA seeks to expand the drug's indication to include the treatment of edema due to fluid overload in patients with chronic kidney disease (CKD). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025.
The company's CEO, John Tucker, expressed optimism about the potential market opportunity for FUROSCIX, citing over one in seven U.S. adults affected by CKD. The company is preparing to increase commercial resources in anticipation of a possible approval, targeting what they estimate to be a $3 billion addressable market.
FUROSCIX is currently approved for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure. It is not indicated for emergency situations or for patients with acute pulmonary edema.
The FDA's acceptance of the sNDA follows feedback from a Type D meeting held last year, where the agency confirmed that no additional clinical studies would be necessary, provided that an adequate pharmacokinetic and pharmacodynamic bridge to the listed drug, furosemide injection, is demonstrated.
scPharmaceuticals focuses on developing products that aim to optimize the delivery of infused therapies, potentially reducing healthcare costs and advancing patient care. The company's primary programs target the subcutaneous administration of IV-strength treatments for heart failure and infectious diseases.
In other recent news, scPharmaceuticals reported its Q1 2024 financials, revealing a net revenue of $6.1 million and a net loss of $14.1 million. Despite a cyber-attack resulting in a 10% loss of doses, the company still managed to maintain positive momentum with its strategic initiatives, including the expansion of its FUROSCIX product indications and a positive trend in prescriber growth. The company's cash and cash equivalents stood at $58.4 million.
The company is in discussions with payers for FUROSCIX and is planning for long-term growth initiatives, including potential expansion of FUROSCIX indication for Class 4 heart failure and CKD patients. A PDUFA date is set for the Class 4 indication in August, with supplemental applications submitted for the CKD indication.
Moreover, the company experienced increased costs across product revenues, R&D, and administrative expenses. Despite these challenges, scPharmaceuticals is moving forward with plans to expand territories and educate physicians on new FUROSCIX indications. These are among the recent developments for the company.
InvestingPro Insights
As scPharmaceuticals Inc. (NASDAQ:SCPH) forges ahead with the FDA review process for the expanded indication of its FUROSCIX drug, investors and industry observers are closely monitoring the company's financial health and market performance. According to the latest data from InvestingPro, scPharmaceuticals holds a market capitalization of $174.5 million. Despite the challenges of not being profitable in the last twelve months, analysts remain optimistic about the company's future, anticipating sales growth in the current year.
InvestingPro Tips for scPharmaceuticals highlight the company's strong cash position relative to its debt, which is an encouraging sign for its financial stability. Additionally, the company's liquid assets surpass short-term obligations, providing a cushion for operational needs as it awaits the FDA's decision. On the performance front, scPharmaceuticals has delivered a significant return over the last week, with a 7.8% increase, and an even more impressive return over the past month, at 22.22%.
For those considering an investment in scPharmaceuticals, exploring additional analysis could be beneficial. InvestingPro offers a range of tips, including insights into the company's Price / Book multiple, which currently stands at 7.1, indicating a high valuation compared to the book value of its assets. Interested readers can find a total of 9 additional InvestingPro Tips for scPharmaceuticals, providing a deeper dive into the company's financial and market performance. To gain access to these insights and more, use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
Overall, the data and tips from InvestingPro suggest that while scPharmaceuticals faces the challenge of turning a profit, the company's strong sales growth prospects and solid balance sheet position it to potentially capitalize on the large market opportunity for FUROSCIX, should the FDA grant the expanded indication.
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