The company said, “Patient enrollment is ongoing in the REVITALYZ pivotal study, a Phase 3 double-blind, placebo-controlled, randomized withdrawal, multicenter study designed to evaluate the efficacy and safety of LUMRYZ in IH. Completion of this study is expected during the second half of 2025. Preclinical development ongoing for a once-nightly, low-/no-sodium oxybate formulation with a target product profile bioequivalent to LUMRYZ. The Company’s full year 2025 guidance is preliminary and based upon the Company’s current view of existing market conditions and assumptions for the year ending December 31, 2025. These statements are forward-looking, and actual results could differ materially depending on market conditions.”
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