Travere pauses Phase 3 HCU trial enrollment due to manufacturing scale-up issues; restart expected in 2026

Travere Therapeutics, Inc.

Voluntary pause of enrollment in Phase 3 HARMONY Study for pegtibatinase (classical homocystinuria).
Desired drug substance profile not achieved in recent scale-up process; process improvements needed.
Currently enrolled patients continue to receive study medication from small scale batches without disruption.
Earliest date to restart enrollment expected in 2026 while company evaluates commercial process improvements.

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