Scpharmaceuticals Inc SCPH shares were hurtling toward their late March lows Monday after a binary event panned out negatively for the biopharma.
What Happened: Burlington, Massachusetts-based scPharma said the FDA issued a complete response letter for its new drug application for Furoscix, a proprietary, subcutaneously delivered furosemide solution being evaluated as an outpatient alternative for the treatment of worsening congestive heart failure.
The application had a PDUFA goal date of Dec. 30.
A CRL is a communication from the FDA that an application cannot be approved in its current form and that lists specific deficiencies identified by the regulatory agency.
In the CRL, the FDA said the rejection is due to its inability to conduct pre-approval inspections at two of scPharma's third-party manufacturing facilities due to travel restrictions.
The FDA raised questions regarding testing, labeling and features of the combination product unrelated to the drug constituent. The agency also pointed out deficiencies at the third-party facility where the company's off-the-shelf alcohol swabs are manufactured.
Why It's Important: scPharma's original NDA was issued a CRL in 2018, wherein the agency sought additional human factor studies, device modifications and potentially a clinical validation study.
The second rejection could hit the shares hard, especially as sell-side was hinting at an approval with the second try.
SVB Leerink analyst Ami Fadia had assigned a 80% probability of success on approval.
What's Next: scPharmaceuticals said it will request a Type A meeting with the FDA to discuss the issues described in the CRL and steps required for the resubmission of the NDA.
In the wake of the regulatory setback, the company said it has sufficient cash to fund operations into 2023 at its projected burn rate.
"While we are disappointed that these on-site inspections, and other issues raised in the CRL, will not be resolved by our previously granted December 30, 2020 PDUFA date, we are committed to working with our manufacturing partners and responding to the agency's concerns as expeditiously as possible," CEO John Tucker said in a statement.
SCPH Price Action: At last check, scPharma shares were plummeting 30.21% to $6.10.
Related Link: Attention Biotech Investors: Mark Your Calendar For December PDUFA Dates
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