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Fly News Breaks for January 25, 2018
SGYP, IRWD
Jan 25, 2018 | 10:57 EDT
Wells Fargo analyst David Maris said that Synergy Pharmaceuticals (SGYP) received FDA approval for Trulance for the treatment of irritable bowel syndrome with constipation, to add to the drug's existing approval for chronic idiopathic constipation. Ironwood's (IRWD) Linzess was initially approved in 2012 for both IBS-C and CIC, noted Maris, who said he expected Trulance's approval in IBS-C and is not making any changes to his Ironwood model following the news. He believes Trulance was already being used off label in IBS-C to some degree, but will be watching if the new on-label indication impacts market share, he said. Maris keeps an Outperform rating on Ironwood shares.
News For IRWD;SGYP From the Last 2 Days
IRWD
Mar 28, 2024 | 07:39 EDT
Ironwood announced primary results up to Day 91 for its Phase II exploratory STARGAZE trial evaluating apraglutide in patients with steroid-refractory gastrointestinal acute Graft-versus-Host Disease. The primary objective of the trial was to evaluate the safety and tolerability of once-weekly apraglutide, a next-generation, long-acting glucagon-like peptide-2, or GLP-2, analog, in SR GI aGVHD patients treated with standard of care, including systemic corticosteroids and ruxolitinib. This was a first-of-its-kind study combining a GLP-2 analog with immunosuppressive therapy in patients with SR GI aGVHD. The safety and tolerability observed in this trial was consistent with the standard of care and known safety of GLP-2 analogs, as well as observed events in the GVHD population. The emerging safety profile of apraglutide in the SR GI aGVHD population was monitored by an independent safety review committee that endorsed the continuation of the study without modification. In addition to evaluating safety, secondary endpoints evaluated efficacy using lower GI and all-organ responses, indicative of organ-level improvement from baseline per the Mount Sinai Acute GVHD International Consortium grading system. The majority of patients responded to treatment by Day 28 and Day 56. All lower GI responders at Day 28 maintained their response through Days 56 and 91, considering available organ staging assessments. aGVHD is a rare, life-threatening condition that occurs when immune cells of the donor attack a recipient's healthy cells after an allogeneic hematopoietic stem cell transplant. The condition typically affects the skin, GI tract, and liver. GI aGVHD, is a leading cause of morbidity and mortality following HSCT with approximately 70% of aGVHD cases having GI involvement. While treatment options exist for aGVHD, a significant number of patients do not respond to 1st line therapy, such as corticosteroids. Despite receiving 2nd line therapy, many patients also do not maintain response over time, with significant non-relapse mortality after six months. Additional data from the STARGAZE trial are expected to be presented at an upcoming medical congress. The STARGAZE study will continue through its two-year endpoint, where apraglutide will be re-evaluated for safety and efficacy.