Soleno withdraws EU rare disease drug application ahead of Neurocrine takeover

Soleno Therapeutics said on Tuesday it has ​voluntarily withdrawn the ​European marketing application for its rare ​metabolic disorder drug following acquirer Neurocrine's plans to sharpen focus on the U.S. market.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%.