scPharmaceuticals Inc. (NASDAQ: SCPH) saw its shares drop massively Wednesday after the firm announced that it had received a letter from the U.S. Food and Drug Administration (FDA). Essentially, the agency sent a Complete Response Letter (CRL) regarding the firm’s heart failure treatment, Furoscix.
The CRL indicated the need for additional human factors studies, device modifications, and potentially a clinical validation study. scPharmaceuticals intends to request a meeting with the FDA to further evaluate the deficiencies raised.
Although scPharmaceuticals is not a very well-known firm, it is a clinical-stage pharmaceutical company focused on developing and commercializing products that reduce healthcare costs and improve health outcomes. The company develops products for the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease.
John Tucker, President and CEO of scPharmaceuticals, commented:
While we are disappointed with the outcome of the review, we are committed to addressing the issues of the CRL and bringing this important product to market. Our team will continue to work closely with the FDA to determine an appropriate path forward regarding product performance, appropriate patient identification, and risk mitigation strategies that ultimately enable a timely resubmission of the FUROSCIX NDA.
Shares of scPharma were last seen down about 23.5% at $5.82, with a consensus analyst price target of $23.33 and a 52-week range of $5.61 to $18.17.
Essential Tips for Investing: Sponsored
A financial advisor can help you understand the advantages and disadvantages of investment properties. Finding a qualified financial advisor doesn’t have to be hard. SmartAsset’s free tool matches you with up to three financial advisors who serve your area, and you can interview your advisor matches at no cost to decide which one is right for you. If you’re ready to find an advisor who can help you achieve your financial goals, get started now.
Investing in real estate can diversify your portfolio. But expanding your horizons may add additional costs. If you’re an investor looking to minimize expenses, consider checking out online brokerages. They often offer low investment fees, helping you maximize your profit.
Thank you for reading! Have some feedback for us?
Contact the 24/7 Wall St. editorial team.
Editors' Picks
