Avadel Pharmaceuticals (AVDL) said Tuesday that the US Court of Appeals for the Federal Circuit has vacated the portion of an injunction imposed by a Delaware court that prohibited the company from applying for FDA approval of Lumryz for any indication beyond narcolepsy.
The court also lifted the portions of the Delaware court's injunction that prohibited the company from offering open-label extensions to trial participants using Lumryz and from initiating new clinical trials or studies for potential indications beyond narcolepsy, the company said.
The company said it expects to complete patient enrollment for its REVITALYZ trial, a phase 3 study to evaluate the efficacy and safety of Lumryz, by the end of 2025.
Avadel shares were 3.2% lower in recent trading.
Price: 8.73, Change: -0.31, Percent Change: -3.43
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