ScPharmaceuticals Stock Falls After Noting Possible FDA Submission Delay

Dow Jones
2024-12-11

By Katherine Hamilton

 

ScPharmaceuticals shares fell Wednesday morning after it disclosed it might have to delay submitting a new product to the Food and Drug Administration.

Shares were down 8% to $3.25 in recent trading. The stock is down about 61.3% this year.

One lot of the company's SCP-111 combination product showed varying results in shelf-life testing, which is the amount of time a product can maintain an acceptable level of quality, the company said in a Wednesday filing.

SCP-111 is designed to treat fluid overload and retention.

The variation could delay when the company submits a supplemental new drug application for the product with the FDA.

ScPharmaceuticals was planning to submit the product for approval in January, but may delay until later in 2025, the company said.

 

Write to Katherine Hamilton at katherine.hamilton@wsj.com

 

(END) Dow Jones Newswires

December 11, 2024 10:24 ET (15:24 GMT)

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