ScPharma's stock droops on 'deficiencies' as FDA tosses back heart failure drug application
It’s vague news from the FDA Thursday morning that halted — then tanked — the stock of scPharmaceuticals, a Burlington, MA-based company awaiting a regulatory decision on its heart failure drug furosemide.
The company’s PDUFA date was set for June 23, but received an early letter from regulators that the agency had “identified deficiencies” with the company’s drug-device combo that “preclude discussion of labeling and postmarketing requirements/commitments at this time.”
ScPharmaceutcals’ stock $SCPH is now down nearly 30% in pre-market trading.
The biotech’s lead drug candidate is a new formulation of furosemide (which you may recognize as Validus Pharmaceutical’s branded drug Lasix), a diuretic that can treat fluid retention and swelling caused by congestive heart failure. ScPharmaceutical’s version of the drug is designed to be delivered with a wearable device at home instead of a hospital IV. The idea is to reduce the number of days a patient must be hospitalized for therapy.
The FDA’s letter does not specify the deficiencies, nor does the letter reflect the final decision of the agency, scPharmaceuticals said in a statement.
“The company intends to work with the FDA to understand the nature of the deficiencies once identified and resolve them as quickly as possible,” the statement reads.
ScPharmaceuticals’ pipeline is more than just its lead heart failure drug. The company also includes two antibiotics: ceftriaxone, an antibiotic currently used intravenously for the treatment of infections caused by gram-positive and gram-negative organisms; and there’s another program for carbapenem, meant to complement ceftriaxone in treatment.