Soleno Therapeutics Stock Rockets 34% Pre-Market After FDA Approves Prader-Willi Syndrome Drug: Retail Sentiment Peaks

Shares of Soleno Therapeutics (SLNO) rocketed nearly 34% in premarket trading on Thursday after the biopharmaceutical company received approval from the Food and Drug Administration (FDA) for its VYKAT XR extended-release tablets.

If the pre-market gains are sustained, the stock is headed toward its eight-year highs on a closing basis.

In adults, VYKAT XR tablets are used to treat hyperphagia, an intense, persistent sensation of hunger. They are also used to treat children of the age of four or above with Prader-Willi syndrome, a rare genetic neurodevelopmental disorder caused by an abnormality in the gene expression on chromosome 15.

PWS is estimated to occur in one in every 15,000 live births.

The company expects the drug, the first approved therapy to address hyperphagia in PWS patients, to be available in the U.S. starting April 2025. The tablets have to be consumed orally once every day.

CEO Anish Bhatnagar said the approval of VYKAT XR is a significant milestone for Soleno and, most importantly, for the PWS community, who have had no options to treat the most disruptive aspect of this disease.

VYKAT XR is the company’s first commercial product.

Soleno said the common adverse effects identified in 10% or more individuals receiving the drug include hypertrichosis, edema, hyperglycemia, and rash.

On Stocktwits, retail investor sentiment about Soleno jumped further into the ‘extremely bullish’ territory (100/100) accompanied by significant retail chatter over the past 24 hours.

SLNO's Sentiment Meter and Message Volume as of 7:50 a.m. ET on March 27, 2025 | Source: Stocktwits

Stocktwits user comments indicated a positive take on the shares.

Soleno shares gained nearly 7% in 2025 and by over 14% over the past 12 months.

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