Travere Therapeutics Announces Voluntary Pause Of Enrollment In Phase 3 HARMONY Study Of Pegtibatinase; Says 'The 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.'
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Travere Therapeutics has voluntarily paused enrollment in its Phase 3 HARMONY study of Pegtibatinase to address necessary process improvements in manufacturing scale-up. This pause is intended to support commercial scale manufacturing and full enrollment in the study.
September 26, 2024 | 8:02 pm
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Travere Therapeutics has paused enrollment in its Phase 3 HARMONY study to improve manufacturing processes for Pegtibatinase. This could delay the study's progress but aims to ensure better manufacturing capabilities.
The pause in enrollment is a strategic move to address manufacturing scale-up issues, which is crucial for the drug's future commercial success. However, this may delay the study's timeline, potentially affecting investor sentiment negatively in the short term.
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