11:12 AM EDT, 04/29/2024 (MT Newswires) -- Soleno Therapeutics ( SLNO ) shares surged 39% in recent Monday trading after the company got breakthrough therapy designation from the US Food and Drug Administration for diazoxide choline to treat Prader-Willi syndrome in patients aged 4 years and older with hyperphagia.

The FDA's breakthrough designation aims to accelerate the development and review of drugs in the US for serious conditions. It's granted when preliminary clinical evidence suggests the drug may offer significant improvement over existing therapies on clinically significant endpoints.

The designation is based on data from the phase 3 Program for diazoxide choline, and the planned submission of a new drug application (NDA) remains on track for mid-2024, Soleno Therapeutics ( SLNO ) said Monday in a statement.

Diazoxide choline has orphan drug designation in the US and EU for Prader-Willi syndrome, and fast track Designation in the US.

Price: 52.59, Change: +14.70, Percent Change: +38.80