Soleno Therapeutics has withdrawn its European marketing application for Vykat XR, a treatment for hyperphagia associated with Prader-Willi syndrome, ahead of its planned acquisition by Neurocrine Biosciences. The move reflects a strategic decision to prioritize the US market, where the therapy has already secured regulatory approval.

The withdrawal allows Neurocrine to streamline its integration plans post-acquisition and focus resources on commercial expansion in the United States. While the European filing has been put on hold, the company indicated that it may revisit regulatory engagement in the region at a later stage.

Vykat XR represents a significant advancement in addressing hyperphagia, a severe and life-threatening symptom of Prader-Willi syndrome, a rare genetic condition with limited treatment options. By concentrating on the US launch and market penetration, Neurocrine aims to maximize the therapy’s near-term commercial potential.

The decision underscores a broader trend among biopharma companies to sequence global market entries based on regulatory clarity and commercial viability. For now, Soleno’s European ambitions take a backseat as the company transitions under Neurocrine’s ownership and aligns with its strategic priorities.