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Travere issued a press release on September 26, 2024, “announc[ing] a voluntary pause of enrollment in the Phase 3 HARMONY Study evaluating pegtibatinase for the treatment of classical homocystinuria (HCU).” Travere stated that “[t]he voluntary enrollment pause enables the Company to work to address necessary process improvements in manufacturing scale-up to support commercial scale manufacturing as well as full enrollment in the HARMONY Study” and that “[t]he voluntary enrollment pause was enacted following the Company’s determination that the desired drug substance profile was not achieved in the recent scale-up process.”
Following this news, Travere’s stock price fell over 6% on September 27, 2024.