Ironwood jumps after FDA rejects Zealand short bowel syndrome drug application

Shares of Ironwood Pharmaceuticals (IRWD) are up $1.17, or 30%, to $5.06 after Zealand Pharma (ZLDPF) announced that the Food and Drug Administration has issued a Complete Response Letter for the company’s New Drug Application for glepaglutide, a long-acting GLP-2 analog, under development for the treatment of adult patients with short bowel syndrome with intestinal failure who are dependent on parenteral support. “While we are certainly disappointed in the FDA’s decision, we remain confident that the data showed robust and compelling evidence of both efficacy and safety for glepaglutide treatment. We remain firm in our belief that glepaglutide provides a significant advance in GLP-2-based therapies for the potential treatment of SBS patients who are dependent on parenteral support,” said David Kendall, MD, Chief Medical Officer of Zealand Pharma. In November, along with Ironwood’s earnings report, CEO Tom McCourt had stated: “With apraglutide, we continue making progress in preparing the NDA submission and remain on track to complete the submission in the first quarter of 2025. Our team is focused on getting apraglutide to market as soon as possible, and we look forward to providing more updates on our progress in the months ahead. We believe that, if approved, apraglutide would be the drug of choice among physicians to treat adult patients with short bowel syndrome who are dependent on parenteral support.”