04:51 PM EDT, 09/26/2024 (MT Newswires) -- Travere Therapeutics ( TVTX ) said Thursday it has voluntarily paused enrollment in its phase 3 Harmony Study of pegtibatinase, a potential therapy for classical homocystinuria, a metabolic disorder.

The decision aims to implement necessary process improvements for a manufacturing scale-up, Travere said, adding that currently enrolled patients will continue to receive study medication from unaffected small-scale batches.

The pause was implemented after the company discovered that the recent scale-up process failed to meet the desired drug substance profile, the biopharmaceutical company said.

Travere expects to resume enrollment in the Harmony Study no earlier than 2026, leading to an expected reduction of over $30 million in research and development expenses in 2025 compared to 2024.

The company said its cash reserves of $325.4 million as of June 30, are projected to sustain operations through 2028.

Shares of Travere were down 4.2% in after-hours trading.

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