By Joe Hoppe

Futura Medical PLC shares rose Wednesday after it said it has submitted a full response to the U.S. Food and Drug Administration's questions on its MED3000 gel formulation for the treatment of erectile dysfunction.

Shares at 0847 GMT were up 4.45 pence, or 10% at 46.95 pence.

The pharmaceutical company said is has also sent the requested confirmatory data, which together with the response, has been resubmitted to enable the FDA to continue its review of MED3000.

The company had said on March 14 that the FDA has asked additional questions and requested some nonclinical confirmatory data related to its application for marketing authorization for MED3000.

"Based on the FDA's published target review period guidelines which includes time to review the newly provided information, the board continue to anticipate grant of the... request in [the second quarter of] 2023," the company said.

Write to Joe Hoppe at joseph.hoppe@wsj.com

(END) Dow Jones Newswires

March 29, 2023 05:06 ET (09:06 GMT)

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