Shares of Soleno Therapeutics SLNO have rallied 37% in the premarket hours today following the FDA approval of Vykat XR (diazoxide choline) extended-release tablets for treating hyperphagia in adults and children aged four years and older with Prader-Willi syndrome (PWS). The company expects to launch the drug in the United States in April 2025.

Soleno’s Vykat XR, previously referred to as DCCR, is an innovative, once-daily, proprietary extended-release dosage form that contains diazoxide choline, the crystalline salt form of diazoxide. Although not approved for treating PWS, the parent molecule, diazoxide, treats a few rare diseases in neonates, infants, children and adults.

Per the PWS Association USA, approximately one in every 15,000 newborns suffers from this rare genetic disorder. The most common symptom of PWS is hyperphagia, an abnormally increased appetite for food, often leading to excessive eating, which takes a serious toll on the quality of life of patients suffering from it. In the long term, hyperphagia often leads to co-morbidities, such as diabetes, obesity and cardiovascular disease.

Year to date, shares of SLNO have gained 8.9% against the industry’s 0.8% decline.

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The Basis for the FDA’s Approval of SLNO’s PWS Drug

The FDA approval of Soleno’s Vykat XR for the PWS indication was based on the success of the phase III Study C602. The study met its primary endpoint, demonstrating a highly statistically significant reduction in hyperphagia-related behaviors as assessed by the hyperphagia questionnaire for clinical trials score, compared to the placebo, during the 16-week randomized withdrawal study period of the late-stage study.

Study C602 also met its secondary endpoints, which showed that during the withdrawal period, the placebo group experienced strong trends of worsening symptoms in the Clinical Global Impression of Severity and Clinical Global Impression of Improvement ratings, compared to patients who received Vykat XR.

Patients who received the drug did not report any new or unexpected side effects. It was well tolerated and no adverse events were reported.

Soleno has established extensive patent protection for the therapeutic use of Vykat XR in PWS patients. It enjoys the FDA’s Breakthrough, Fast Track and Orphan Drug designations in the United States. In the EU, the drug enjoys the Orphan Drug Designation for the same indication.

Soleno’s Competition in the Target Market

Please note that Acadia Pharmaceuticals ACAD also added a new study candidate to its rare disease portfolio, carbetocin nasal spray (ACP-101), to treat hyperphagia associated with PWS in 2023. Acadia acquired worldwide rights to develop and commercialize carbetocin nasal spray with the acquisition of Levo Therapeutics in June 2022.

In a previous late-stage study conducted by Levo, carbetocin demonstrated a nominally statistically significant reduction in hyperphagia-related behaviors in PWS patients. Consequently, in 2023, Acadia initiated a pivotal phase III COMPASS PWS study evaluating the efficacy and safety of the candidate for the same indication. Enrollment of the last patient in the study is likely to be completed in the fourth quarter of 2025, while top-line data from the same is expected in the first half of 2026.

Soleno Therapeutics, Inc. Price and Consensus

Soleno Therapeutics, Inc. price-consensus-chart | Soleno Therapeutics, Inc. Quote

SLNO’s Zacks Rank & Stocks to Consider

Soleno currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks from the sector are Bayer BAYRY and Corcept Therapeutics CORT, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 (Strong Buy) Rank stocks here.

In the past 30 days, estimates for Bayer’s earnings per share have increased from $1.14 to $1.19 for 2025. During the same time, earnings per share have increased from $1.23 to $1.28 for 2026. In the past six months, shares of Bayer have gained 27.7%.

BAYRY’s earnings matched estimates in two of the trailing three quarters while missing the same on the remaining occasion, the average negative surprise being 19.61%.

In the past 30 days, the estimate for Corcept Therapeutics’ 2025 earnings per share has increased from $1.85 to $1.87. The estimate for 2026 earnings per share has remained constant at $3.11. In the past six months, shares of Corcept Therapeutics have gained 23.4%.

CORT’s earnings beat estimates in three of the trailing four quarters and missed once, delivering an average surprise of 20.08%.

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This article originally published on Zacks Investment Research (zacks.com).

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