April 7 (Reuters) – Soleno Therapeutics said on Tuesday it has voluntarily withdrawn the European marketing application for its rare metabolic disorder drug following acquirer Neurocrine’s plans to sharpen focus on the U.S. market.
Soleno, which Neurocrine Biosciences will acquire for $2.9 billion, said in a filing the withdrawal was “based on business and strategic considerations.”
The move “preserves the company’s ability to re-engage with regulators at a later date,” it added.
The drug, branded Vykat XR in the United States, was the first approved in the country to treat hyperphagia associated with Prader-Willi syndrome, a rare genetic disorder.
Neurocrine CEO Kyle Gano said on Monday that his company currently has no plans to launch the drug in Europe as it focuses on the U.S. market.
He also said the decision was not related to potential risks from President Donald Trump’s most-favored-nation drug pricing policy but was based on “looking at making sure that we continue focusing on the U.S. launch in rare disease.”
A European Medicines Agency decision on the drug had originally been expected in mid-2026.
The withdrawal comes amid a broader trend of drugmakers delaying launches of some new medicines in Europe as the industry grapples with U.S. pricing policy shifts.
Shares of Neurocrine were down 1.1%.
(Reporting by Puyaan Singh in Bengaluru; Editing by Tasim Zahid)
Comments