Ironwood Pharma: FDA Grants Priority Review To SNDA For LINZESS

(RTTNews) - Ironwood Pharmaceuticals, Inc. (IRWD) announced the FDA has granted Priority Review to the supplemental New Drug Application for LINZESS for the treatment of children and adolescents ages 6-17 years-old with functional constipation. The FDA has assigned the application a PDUFA date of June 14th, 2023, four months earlier than the standard review cycle. The sNDA filing was based on the results of a large, multicenter, double-blind, Phase III study.

Tom McCourt, CEO of Ironwood Pharmaceuticals, said: "If approved, we look forward to a commercial launch mid-2023."

Shares of Ironwood Pharmaceuticals are up 4% in pre-market trade on Monday.

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