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Soleno (SLNO) Soars as Prader-Willi Syndrome Study Meets Goal
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Soleno Therapeutics (SLNO - Free Report) announced that a late-stage study on its lead candidate, diazoxide choline (DCCR) extended-release tablets for treating Prader-Willi syndrome (PWS), a rare genetic disease, met its primary and secondary endpoints. The highly statistically significant data from the randomized withdrawal phase of Study C602 caused the company’s shares to soar 505% on Sep 26.
Following the positive results, the company now plans to submit a new drug application to the FDA by mid-2024 for DCCR to treat PWS.
The phase III Study C602, is a multicenter, long-term study of DCCR for patients with PWS. 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.
The study 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 DCCR.
Patients who received DCCR did not report any new or unexpected side effects. DCCR was well tolerated and no adverse events were reported.
Shares of Soleno have rallied 1253.5% year to date against the industry’s 8.2% decline.
Image Source: Zacks Investment Research
PWS is a rare genetic disorder, occurring in one in 15,000 live births. The disorder causes abnormally strong hunger signals along with physical, mental and behavioral problems.Currently, there are no approved treatments for its core symptoms.
As there are no approved products inSoleno’s portfolio, the successful approval and launch of DSSR tablets will be a huge boost for the company.
DCCR was grated the Orphan Drug designation for treating PWS by the European commission and the FDA in October 2017 and May 2014, respectively. DCCR was also granted the Fast Track designation by the FDA in July 2018, for the same indication. These designations provide SLNO with additional market exclusivity and expedites development and review of drugs.
In the past 90 days, the Zacks Consensus Estimate forAnika Therapeutics has narrowed from a loss of $1.41 per share to a loss of $1.24 for 2023. The bottom-line estimate has widened from a loss of 79 cents to a loss of 82 cents for 2024 during the same time frame. Shares of the company have lost 37.5% year to date.
ANIK’s earnings beat estimates in one of the trailing four quarters and missed the mark in the remaining three, delivering an average negative surprise of 32.12%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to a loss of $2.77 for 2024 during the same time frame. Shares of the company have lost 28.8% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 62 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 61 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 59.1% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.
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Soleno (SLNO) Soars as Prader-Willi Syndrome Study Meets Goal
Soleno Therapeutics (SLNO - Free Report) announced that a late-stage study on its lead candidate, diazoxide choline (DCCR) extended-release tablets for treating Prader-Willi syndrome (PWS), a rare genetic disease, met its primary and secondary endpoints. The highly statistically significant data from the randomized withdrawal phase of Study C602 caused the company’s shares to soar 505% on Sep 26.
Following the positive results, the company now plans to submit a new drug application to the FDA by mid-2024 for DCCR to treat PWS.
The phase III Study C602, is a multicenter, long-term study of DCCR for patients with PWS. 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.
The study 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 DCCR.
Patients who received DCCR did not report any new or unexpected side effects. DCCR was well tolerated and no adverse events were reported.
Shares of Soleno have rallied 1253.5% year to date against the industry’s 8.2% decline.
Image Source: Zacks Investment Research
PWS is a rare genetic disorder, occurring in one in 15,000 live births. The disorder causes abnormally strong hunger signals along with physical, mental and behavioral problems.Currently, there are no approved treatments for its core symptoms.
As there are no approved products inSoleno’s portfolio, the successful approval and launch of DSSR tablets will be a huge boost for the company.
DCCR was grated the Orphan Drug designation for treating PWS by the European commission and the FDA in October 2017 and May 2014, respectively. DCCR was also granted the Fast Track designation by the FDA in July 2018, for the same indication. These designations provide SLNO with additional market exclusivity and expedites development and review of drugs.
Soleno Therapeutics, Inc. Price
Soleno Therapeutics, Inc. price | Soleno Therapeutics, Inc. Quote
Zacks Rank & Stocks to Consider
Soleno currently carries a Zacks Rank #3 (Buy).
Some better-ranked stocks in the same industry are Anika Therapeutics (ANIK - Free Report) , Annovis Bio (ANVS - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate forAnika Therapeutics has narrowed from a loss of $1.41 per share to a loss of $1.24 for 2023. The bottom-line estimate has widened from a loss of 79 cents to a loss of 82 cents for 2024 during the same time frame. Shares of the company have lost 37.5% year to date.
ANIK’s earnings beat estimates in one of the trailing four quarters and missed the mark in the remaining three, delivering an average negative surprise of 32.12%.
In the past 90 days, the Zacks Consensus Estimate for Annovis Bio has narrowed from a loss of $4.89 per share to a loss of $4.38 for 2023. The bottom-line estimate has narrowed from a loss of $3.18 to a loss of $2.77 for 2024 during the same time frame. Shares of the company have lost 28.8% year to date.
ANVS’ earnings beat estimates in three of the trailing four quarters and missed the mark in one, delivering an average surprise of 13.40%.
In the past 90 days, the Zacks Consensus Estimate for Corcept’s earnings has gone up from 62 cents per share to 78 cents for 2023. The bottom-line estimate has also improved from 61 cents to 83 cents for 2024 during the same time frame. Shares of the company have rallied 59.1% year to date.
CORT’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 6.99%.