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Soleno Stock Up as FDA Accepts PWS Drug NDA Under Priority Review
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Soleno Therapeutics (SLNO - Free Report) gained 6.3% on Aug. 27 after the FDA accepted the new drug application (NDA) seeking approval for its lead candidate, DCCR (diazoxide choline) extended-release tablets, to treat Prader-Willi syndrome (PWS) in patients aged four years and older who have hyperphagia, under the Priority Review pathway. A filing designated as a Priority Review reduces the review period to four months. A final decision from the FDA is expected on Dec. 27, 2024.
The regulatory body in the United States further stated that it plans to hold an advisory committee meeting to discuss Soleno’s application for DCCR.
DCCR is a novel, oral, once-daily extended-release dosage form containing diazoxide choline, the crystalline salt of diazoxide. Although not approved for treating PWS, the parent molecule, diazoxide, treats a few rare diseases in neonates, infants, children and adults.
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.
Year to date, shares of SLNO have rallied 21.8% against the industry’s 1% decline.
Image Source: Zacks Investment Research
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 last year, Acadia Pharmaceuticals (ACAD - Free Report) also added a new study candidate to its rare disease portfolio, carbetocin nasal spray (ACP-101), to treat hyperphagia associated with PWS. 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. Stock Price and Consensus
In the past 60 days, the consensus estimate for Fulcrum Therapeutics’ 2024 loss per share has narrowed from $1.24 to 48 cents. The loss estimate for 2025 has narrowed from $1.71 to $1.51 during the same period. Year to date, shares of Fulcrum Therapeutics have jumped 31.3%.
FULC beat estimates in each of the last four quarters, delivering an average earnings surprise of 393.18%.
In the past 60 days, the consensus estimate for Bioventus’ 2024 earnings per share has risen from 27 cents to 40 cents. The estimate for 2025 has increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 83.3%.
BVS beat estimates in three of the last four quarters and missed the mark on one occasion, delivering an average earnings surprise of 102.86%.
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Soleno Stock Up as FDA Accepts PWS Drug NDA Under Priority Review
Soleno Therapeutics (SLNO - Free Report) gained 6.3% on Aug. 27 after the FDA accepted the new drug application (NDA) seeking approval for its lead candidate, DCCR (diazoxide choline) extended-release tablets, to treat Prader-Willi syndrome (PWS) in patients aged four years and older who have hyperphagia, under the Priority Review pathway. A filing designated as a Priority Review reduces the review period to four months. A final decision from the FDA is expected on Dec. 27, 2024.
The regulatory body in the United States further stated that it plans to hold an advisory committee meeting to discuss Soleno’s application for DCCR.
DCCR is a novel, oral, once-daily extended-release dosage form containing diazoxide choline, the crystalline salt of diazoxide. Although not approved for treating PWS, the parent molecule, diazoxide, treats a few rare diseases in neonates, infants, children and adults.
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.
Year to date, shares of SLNO have rallied 21.8% against the industry’s 1% decline.
Image Source: Zacks Investment Research
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 last year, Acadia Pharmaceuticals (ACAD - Free Report) also added a new study candidate to its rare disease portfolio, carbetocin nasal spray (ACP-101), to treat hyperphagia associated with PWS. 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. Stock Price and Consensus
Soleno Therapeutics, Inc. price-consensus-chart | Soleno Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Soleno currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the overall drug/biotech sector include Fulcrum Therapeutics (FULC - Free Report) and Bioventus (BVS - Free Report) , 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, the consensus estimate for Fulcrum Therapeutics’ 2024 loss per share has narrowed from $1.24 to 48 cents. The loss estimate for 2025 has narrowed from $1.71 to $1.51 during the same period. Year to date, shares of Fulcrum Therapeutics have jumped 31.3%.
FULC beat estimates in each of the last four quarters, delivering an average earnings surprise of 393.18%.
In the past 60 days, the consensus estimate for Bioventus’ 2024 earnings per share has risen from 27 cents to 40 cents. The estimate for 2025 has increased from 43 cents to 45 cents during the same period. Year to date, shares of Bioventus have surged 83.3%.
BVS beat estimates in three of the last four quarters and missed the mark on one occasion, delivering an average earnings surprise of 102.86%.