Soleno Therapeutics receives breakthrough therapy designation from FDA for PWS treatment
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 29 2024
0mins
Should l Buy SLNO?
Source: SeekingAlpha
- FDA Breakthrough Therapy Designation: Soleno Therapeutics' diazoxide choline receives FDA Breakthrough Therapy Designation for treating Prader-Willi syndrome in adults and children aged 4 years and older with hyperphagia.
- Orphan Drug Designation: Diazoxide choline has Orphan Drug Designation for Prader-Willi syndrome in the U.S. and E.U.
- Fast Track Designation: The drug also holds Fast Track Designation in the U.S.
- Financial Performance: Soleno Therapeutics reports a GAAP EPS of -$0.33, missing expectations by $0.07.
- Seeking Alpha's Quant Rating: Seeking Alpha provides a Quant Rating on Soleno Therapeutics along with historical earnings data and financial information.
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Analyst Views on SLNO
Wall Street analysts forecast SLNO stock price to rise
8 Analyst Rating
8 Buy
0 Hold
0 Sell
Strong Buy
Current: 38.630
Low
75.00
Averages
110.50
High
125.00
Current: 38.630
Low
75.00
Averages
110.50
High
125.00
About SLNO
Soleno Therapeutics, Inc. is a biopharmaceutical company. The Company is focused on developing novel therapeutics for the treatment of rare diseases. The Company’s lead product candidate, diazoxide choline extended-release tablets (DCCR), is for the treatment of Prader-Willi syndrome (PWS) in individuals four years and older who have hyperphagia. DCCR contains diazoxide choline, a potent ATP-sensitive potassium (KATP) channel activator. DCCR tablets consist of the active ingredient diazoxide choline, a choline salt of diazoxide, which is a benzothiadiazine. Its proposed mode of action, with targets in the brain, pancreas and fat tissue, has the potential to broadly impact complex diseases like PWS to reduce appetite, reduce food-seeking, decrease insulin and leptin resistance, and reduce body fat. The Company has Breakthrough Therapy and Fast-Track designations in the United States and Orphan Drug designations in the United States and European Union.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Legal Investigation Initiated: Kirby McInerney LLP is investigating potential violations of federal securities laws by Soleno and its executives, which may lead to further legal and financial risks, impacting investor confidence.
See More
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- Peakstone Realty Trust Price Surge: Shares of Peakstone Realty Trust soared 32.5% to $20.70 on Friday, reflecting positive market sentiment regarding the company's future prospects and the anticipated benefits of the acquisition.
- Acquisition Announcement: Brookfield announced plans to acquire Peakstone Realty Trust in a $1.2 billion all-cash deal, which not only enhances Brookfield's asset portfolio but also signals its strategic intent to expand further in the real estate sector.
- Positive Market Reaction: Following the acquisition news, Peakstone Realty Trust's stock price surged, indicating strong investor confidence in the deal and potentially attracting additional investment into the company.
See More
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- Shareholder Rights Investigation: Johnson Fistel, PLLP is investigating whether Soleno Therapeutics violated federal securities laws by potentially making false or misleading statements, which may have harmed shareholder interests.
- Product Launch Challenges: Despite claiming strong performance for VYKAT™ XR post-FDA approval in September 2025, management acknowledged during the November 2025 earnings call that the launch faced challenges, including a slowdown in new treatment initiations and increased therapy discontinuations.
- Impact of Short Seller Report: Following a report from short seller Scorpion Capital on August 15, 2025, which raised concerns about the safety and demand for VYKAT™ XR, Soleno's stock price experienced significant volatility, declining nearly 40% from August 14 to November 5, 2025.
- Business Model Risks: The Scorpion report criticized Soleno's business model for being overly reliant on a single product with expiring intellectual property protection, raising investor concerns about the company's long-term sustainability and strategic direction.
See More
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- Stock Price Drop: On August 15, 2025, Soleno's shares fell from $77.36 to $71.64, a decline of approximately 7.41%, following a report by Scorpion Capital labeling its only product, Vykat XR, as overpriced and potentially unsafe for children.
- Increased Discontinuation Rate: During the earnings call on November 4, 2025, Soleno's CEO disclosed that the discontinuation rate for Vykat XR due to adverse effects was around 8% at the end of Q3 2025, raising significant safety concerns among investors.
- Severe Stock Plunge: Following the earnings report, Soleno's stock plummeted from $63.85 to $46.87, a staggering drop of 26.59%, reflecting investors' extreme pessimism regarding the company's future prospects.
- Legal Investigation Initiated: Kirby McInerney LLP has reminded investors of an ongoing investigation into potential violations of federal securities laws by Soleno and its senior management, which could adversely affect the company's reputation and future stock performance.
See More
Soleno Therapeutics (SLNO) Shares Plunge 28% Following VYKAT™ XR Disappointment
- Stock Price Plunge: On November 5, 2025, Soleno Therapeutics saw its shares drop by $18.78, or 28%, following disappointing news regarding VYKAT™ XR, significantly undermining investor confidence and reflecting market concerns about the company's future prospects.
- Post-FDA Approval Setback: Despite claiming in September 2025 that VYKAT™ XR's launch was exceeding expectations after FDA approval, the company admitted during its November earnings call that its launch trajectory faced disruptions, highlighting significant challenges in product promotion.
- Increased Market Risks: Short seller Scorpion Capital raised alarms about reports of children hospitalized for potential heart failure after using VYKAT™ XR, suggesting the drug could face withdrawal risks from the market, further intensifying the crisis of confidence among investors in Soleno.
- Ongoing Investigation: Hagens Berman is investigating whether Soleno misled investors regarding the commercial prospects of VYKAT™ XR, and if confirmed, such misconduct could have profound implications for the company's future operations and stock price.
See More
Soleno Therapeutics Shares Drop 26.59% Following Safety Concerns Over Vykat XR
- Stock Price Plunge: Following a report from Scorpion Capital labeling Soleno's sole product, Vykat XR, as overpriced and potentially unsafe for children, the company's shares fell by $5.73 on August 15, 2025, representing a decline of approximately 7.41%.
- Rising Discontinuation Rate: During the quarterly earnings call on November 4, 2025, Soleno's CEO disclosed that the discontinuation rate for Vykat XR due to adverse effects was around 8% at the end of Q3 2025, raising further concerns among investors.
- Significant Stock Drop: Following the earnings report, Soleno's stock plummeted by $16.98, or 26.59%, from $63.85 to $46.87 on November 5, 2025, reflecting strong investor apprehension regarding product safety.
- Ongoing Legal Investigation: Kirby McInerney LLP is investigating potential violations of federal securities laws by Soleno and its senior management on behalf of investors, which could have significant implications for the company's future legal and financial standing.
See More
Soleno Therapeutics Faces Investigation After Vykat XR Price Drop of 26.59%
- Stock Price Plunge: Following the release of Scorpion Capital's report, Soleno's share price dropped from $77.36 to $71.64, a decline of 7.41%, indicating market concerns over the safety of its product.
- Increased Discontinuation Rate: During the Q3 2025 earnings call, Soleno revealed an 8% discontinuation rate for Vykat XR due to adverse effects, leading to a further stock price drop of 26.59% the following day, reflecting diminished investor confidence.
- Management Impact: The CEO noted that the short seller report disrupted Vykat XR's launch trajectory, highlighting the company's vulnerability in managing negative market sentiment, which could affect future financing and market performance.
- Legal Investigation Initiated: Kirby McInerney LLP is investigating potential violations of federal securities laws by Soleno and its executives, which may lead to further legal and financial risks, impacting investor confidence.
See More
