Shares of Soleno Therapeutics SLNO jumped 9.1% on Tuesday and continued to gain another 4.1% during the after-market hours following a positive regulatory update on its new drug application (NDA) seeking approval for DCCR (diazoxide choline) extended-release tablets to treat Prader-Willi syndrome (PWS).

Per SLNO, the Review Division of the FDA has stated that there is no need for an advisory committee meeting for the DCCR NDA at present. However, the regulatory body will continue to consider the potential need for the same during the ongoing review process.

Soleno’s lead candidate, 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.

Year to date, shares of SLNO have rallied 29.1% against the industry’s 5.2% decline.

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The company’s DCCR NDA for PWS in individuals aged four years and older who have hyperphagia is currently being reviewed by the FDA under its Priority Review pathway. A filing designated as a Priority Review reduces the review period to four months. A final decision from the regulatory body is expected on Dec. 27, 2024.

Soleno has established extensive patent protection for the therapeutic use of diazoxide, diazoxide choline and DCCR in PWS patients. Diazoxide choline enjoys the FDA’s Breakthrough, Fast Track and Orphan Drug designations in the United States. In the EU, the candidate enjoys the Orphan Drug Designation for the same indication.

Per the PWS Association USA, approximately one in every 15,000 newborns suffer 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.

Currently, there are no approved treatments for hyperphagia/appetite, metabolic, cognitive function or behavioral aspects of PWS. This represents a significant unmet medical need.

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 last year. 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 the fourth quarter of 2023, Acadia initiated a pivotal phase III COMPASS PWS study evaluating the efficacy and safety of the candidate for the same indication.

Soleno Therapeutics, Inc. Price and Consensus

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

SLNO’s Zacks Rank & Other Stocks to Consider

Soleno currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP and Alnylam Pharmaceuticals ALNY, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share (EPS) have moved up from $4.69 to $4.81. EPS estimates for 2025 have improved from $5.37 to $5.86, during the same period. Year to date, shares of ANIP have gained 3%.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.

In the past 60 days, estimates for Alnylam’s 2024 loss per share have narrowed from $1.20 to 63 cents. Loss per shares estimates for 2025 have narrowed from 34 cents to 27 cents, during the same period. Year to date, shares of ALNY have risen 41.7%.

Alnylam’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 108.53%.

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