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.