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MIRM-News
MIRM-Events
Mirum Pharmaceuticals Shares Drop 10% to $95.42
Shares of Mirum Pharmaceuticals are moving lower after disclosing the FDA asked for a late-stage study in sclerosing cholangitis. At a recent pre-new drug application meeting, the agency recommended conducting a Phase 3 study for volixibat, Mirum said in last night's earnings release. The company intends to hold further discussions with the FDA before a potential NDA submission in the first half of 2027. Shares of Mirum are down 10% to $95.42 in afternoon trading.
Arcutis Appoints Christopher Peetz to Board of Directors
Arcutis Biotherapeutics (ARQT) announced that Christopher Peetz has been appointed to the Arcutis board of directors effective July 15. Peetz currently serves as a co-founder and chief executive officer of Mirum Pharmaceuticals (MIRM).
Mirum and Incyte Announce Phase 2 Results for Zilurgisertib
Mirum Pharmaceuticals (MIRM) and Incyte (INCY) announced Phase 2 results from Cohort 1 of the Progress study evaluating zilurgisertib, an investigational oral activin receptor-like kinase 2 inhibitor, in adolescents and adults with fibrodysplasia ossificans progressiva. Results were shared in a late-breaking rapid-fire presentation at ENDO 2026, the Endocrine Society's annual meeting. Key efficacy findings included: Fewer patients receiving zilurgisertib developed new HO lesions at Week 24, with an 81% reduction versus placebo. 99.9% reduction in total volume of new HO lesions in patients receiving zilurgisertib versus placebo at Week 24. Reduction in total existing HO lesion volume compared with an increase observed in placebo-treated patients at Week 24. Among patients receiving zilurgisertib, no new HO lesions were observed and total HO lesion volume continued to decrease from Week 24 to Week 48. Among patients who crossed over from placebo to zilurgisertib, no new HO lesions were observed and total HO lesion volume decreased from Week 24 to Week 48.
Mirum and Incyte to Present Zilurgisertib Study Results at ENDO 2026
Mirum Pharmaceuticals (MIRM) and Incyte (INCY) announced that Phase 2 results from the PROGRESS study evaluating zilurgisertib, an investigational ALK2 inhibitor, in patients with fibrodysplasia ossificans progressiva will be presented at ENDO 2026, the Endocrine Society's annual meeting, taking place June 13-16, 2026, in Chicago, Illinois. "ENDO 2026 is an important milestone for the zilurgisertib FOP program as we share pivotal results from the PROGRESS study in patients living with this debilitating disease," said Steven Stein, M.D., Executive Vice President, Chief Medical Officer and Head of Late-stage Development at Incyte. "These data add to the growing clinical understanding of zilurgisertib's potential in FOP as Incyte and Mirum continue to advance toward the FDA's Priority Review PDUFA date of September 26, 2026."
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