Redwood City, Calif., April 7, 2026, 05:10 PDT
- Just a day after striking a $2.9 billion deal to be acquired by Neurocrine Biosciences, Soleno pulled its European application for VIOKAT on Tuesday.
- Neurocrine has put $53 per share on the table, all cash, and expects the deal to wrap up in about 90 days pending typical closing conditions.
- Vykat XR pulled in $190.4 million in sales for 2025, but the anticipated European review, once slated to wrap up by mid-2026, is no longer happening.
Soleno Therapeutics yanked its European application for VIOKAT on Tuesday, just a day after striking a $2.9 billion cash deal to be acquired by Neurocrine Biosciences. That move halts a regulatory review Soleno had earlier projected might wrap up by mid-2026.
The timing here is critical: Vykat XR, which Soleno is rolling out in the U.S., marks its debut product and stands as the only FDA-approved therapy targeting hyperphagia—persistent, insatiable hunger—in patients with Prader-Willi syndrome. Neurocrine is snapping up Vykat XR to bulk up a rare-disease portfolio that already features Ingrezza and Crenessity. With activity outside the U.S. on hold, though, one obvious expansion track now narrows.
Soleno has pulled back its marketing authorization application in Europe, according to a securities filing. The company pointed to “business and strategic considerations” for the withdrawal, leaving the door open to possibly reapplying with regulators down the line. Still, Soleno cautioned that a future resubmission isn’t guaranteed. SEC
It’s a sharp turnaround. Back in February, Chief Executive Anish Bhatnagar told investors Soleno aimed to move ahead with approvals elsewhere, kicking off in the EU. By last May, the company announced the European Medicines Agency had accepted its filing for review, highlighting roughly 9,500 patients in the five largest EU countries and the prospect of up to a decade of rare-disease market exclusivity if the drug cleared regulators.
Neurocrine on Monday said it will acquire Soleno for $53 per share, putting the deal’s value around $2.9 billion. That’s a 34% premium to Soleno’s April 2 closing price and 51% above where shares have traded on average over the last month. Neurocrine plans to fund the purchase with existing cash and a bit of prepayable debt. Both firms aim to wrap up the transaction in roughly 90 days.
Neurocrine is picking up Vykat XR, a drug that cleared U.S. approval in March 2025. Last year, Vykat XR brought in $190.4 million in net sales, with $91.7 million of that coming from the fourth quarter alone. The company says the drug targets roughly 10,000 people in the U.S. diagnosed with Prader-Willi syndrome.
Neurocrine CEO Kyle Gano described Vykat XR as “a potential blockbuster in the making,” adding on Monday there’s no European rollout in the works right now, with the company keeping its sights on the U.S. For Soleno, shares soared close to 33% after the deal was made public. RBC’s Brian Abrahams called the acquisition “a third leg to the story,” while Cantor analyst Josh Schimmer projected annual sales could surpass $1 billion by 2029. Reuters
Bhatnagar called Neurocrine “the right strategic partner” for bringing Vykat XR to a wider audience. With Tuesday’s filing, the European review is off the table for now. Neurocrine Biosciences
But nothing’s set in stone. According to Soleno’s merger filing, the deal hinges on a majority of shareholders signing off and clearing antitrust checks; either party can pull out if things aren’t wrapped by Oct. 5. Dropping Europe also eliminates what could have been a mid-2026 trigger.
Until the FDA gave the green light last year, no treatment targeting hyperphagia in Prader-Willi syndrome had made it through approval. The symptom’s impact? It can push patients toward dangerous obesity, diabetes, and a host of related health issues.
