Soleno Therapeutics Withdraws EU Drug Application Ahead of Neurocrine Acquisition
Soleno withdraws EU rare disease drug application ahead of Neurocrine takeover
The Economic TimesImage: The Economic Times
Soleno Therapeutics has voluntarily withdrawn its European marketing application for the rare disease drug Vykat XR, following its acquisition by Neurocrine Biosciences for $2.9 billion. This strategic decision allows Soleno to potentially re-engage with EU regulators later, as Neurocrine focuses on the U.S. market.
- 01Soleno Therapeutics withdrew its EU drug application for Vykat XR.
- 02The withdrawal is part of a strategic focus by Neurocrine Biosciences on the U.S. market.
- 03Vykat XR treats hyperphagia associated with Prader-Willi syndrome.
- 04Neurocrine's CEO stated that there are no plans to launch the drug in Europe.
- 05The decision reflects a broader trend of drugmakers delaying launches in Europe.
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Soleno Therapeutics announced on Tuesday the voluntary withdrawal of its European marketing application for Vykat XR, a drug aimed at treating hyperphagia associated with Prader-Willi syndrome. This decision comes as part of a strategic shift following the company's acquisition by Neurocrine Biosciences for $2.9 billion. Neurocrine's CEO, Kyle Gano, indicated that the company will focus on launching the drug in the U.S. market and currently has no plans for a European launch. The European Medicines Agency was expected to make a decision on the drug by mid-2026. This withdrawal aligns with a growing trend among pharmaceutical companies to delay new medicine launches in Europe amid changing U.S. pricing policies. Following the announcement, shares of Neurocrine fell by 1.1%.
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