Welcome to our dedicated page for Soleno Therapeutics news (Ticker: SLNO), a resource for investors and traders seeking the latest updates and insights on Soleno Therapeutics stock.
News about Soleno Therapeutics, Inc. (NASDAQ: SLNO) centers on its work as a biopharmaceutical company developing and commercializing novel therapeutics for rare diseases, with a primary focus on Prader-Willi syndrome (PWS) and hyperphagia. Company press releases highlight clinical, regulatory, commercial, and corporate developments related to its first commercial product, VYKAT XR (diazoxide choline) extended-release tablets.
Readers following SLNO news can find updates on VYKAT XR, a once-daily oral treatment indicated for hyperphagia in adults and pediatric patients 4 years of age and older with PWS. News items include details of the Phase 3 clinical program, such as the randomized withdrawal study published in the Journal of Clinical Endocrinology and Metabolism, which Soleno reports supported FDA approval as the first treatment for hyperphagia in people living with PWS.
Soleno’s news flow also covers financial results and launch metrics for VYKAT XR, including product revenue from U.S. sales, patient start forms, prescriber adoption, coverage levels, and commentary on achieving profitability and positive cash flow. Investors can track announcements about preliminary and full-quarter results, conference call schedules, and corporate presentations.
Additional news topics include capital allocation and corporate actions, such as the Board-authorized $100 million accelerated share repurchase agreement, amendments to loan facilities, and Board and Audit Committee changes. The company also issues communications on safety and regulatory matters, including an 8-K describing a serious adverse event reported in the FDA’s FAERS database and Soleno’s assessment of that case.
For those monitoring SLNO, this news stream provides insight into Soleno’s rare disease strategy, the commercial trajectory of VYKAT XR in PWS, and key corporate and regulatory milestones disclosed through press releases and SEC-referenced communications.
Soleno Therapeutics (NASDAQ: SLNO) presented new data on VYKAT XR (diazoxide choline) for Prader-Willi Syndrome (PWS) treatment at the 2025 United in Hope conference. Two key findings were highlighted: First, VYKAT XR showed significant reduction in hyperphagia symptoms (p ≤ 0.0001) in patients under strict food control through Year 3. Second, the drug demonstrated similar efficacy in both pre-diabetic/diabetic and normoglycemic patients at Week 156 (p<0.0001).
The study revealed that 60% of participants had pre-diabetes or diabetes at baseline. While hyperglycemia-related adverse events were higher in the pre-diabetic/diabetic group (42.7% vs 24.0%), they were generally manageable with low discontinuation rates (4.0% vs 6.0%).
Soleno Therapeutics (NASDAQ: SLNO) announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for Diazoxide Choline Prolonged-Release Tablets (DCCR) to treat hyperphagia in Prader-Willi syndrome (PWS) patients aged four and older. The treatment, recently approved by the FDA under the brand name VYKAT™ XR in March 2025, targets approximately 9,500 PWS patients across the UK, France, Germany, Italy, and Spain.
The company has received Orphan Drug Designation in the EU, potentially granting up to 10 years of market exclusivity if approved, along with additional regulatory and financial benefits. This validation marks a crucial step in Soleno's mission to provide treatment for PWS patients in the EU.
Soleno Therapeutics (NASDAQ: SLNO), a biopharmaceutical company focused on rare disease therapeutics, has announced its participation in two major healthcare conferences in June 2025:
- Jefferies Global Healthcare Conference: Corporate presentation scheduled for Wednesday, June 4, 2025, at 10:30 AM ET
- Goldman Sachs 46th Healthcare Conference: Corporate presentation scheduled for Tuesday, June 10, 2025, at 8:40 AM ET
Both presentations will be available for replay in the Investors section of Soleno's website.
Soleno Therapeutics (NASDAQ: SLNO) presented clinical data for VYKAT™ XR (diazoxide choline) at the Pediatric Endocrine Society Annual Meeting 2025. The data demonstrated significant improvements in hyperphagia and behavioral symptoms in Prader-Willi Syndrome (PWS) patients after resuming treatment following a withdrawal period.
After approximately 3 years of open-label treatment and a 16-week randomized withdrawal period, patients who restarted VYKAT XR showed notable improvements within 13 weeks. Key findings include a 6.3-point reduction in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score at one year, returning to pre-withdrawal baseline levels. The study also reported improvements across all six behavioral domains assessed.
Soleno Therapeutics (NASDAQ: SLNO) announced two upcoming presentations at the ISPOR 2025 conference in Montreal, focusing on their drug VYKAT™ XR (diazoxide choline) for treating hyperphagia in Prader-Willi syndrome (PWS). The first presentation will discuss mortality rates and treatment outcomes from a Phase 3 clinical trial of VYKAT™ XR. The second presentation will examine the healthcare burden of PWS through analysis of emergency department visits and inpatient stays in US claims data. Both presentations will be delivered by Raj Gandhi, PharmD MBA on May 14 and 15, 2025.
Soleno Therapeutics (NASDAQ: SLNO) has announced it will release its first quarter 2025 financial results and operational highlights after U.S. market close on Wednesday, May 7, 2025. The company will host its inaugural quarterly conference call and webcast at 4:30 PM ET on the same day.
The conference call will be accessible via U.S. toll-free number (1-800-717-1738), international number (1-646-307-1865), and Conference ID: 57643. A webcast replay will be available on the company's website for 30 days.
The PR also includes safety information for VYKAT XR, indicated for hyperphagia treatment in PWS patients aged 4 and older. Key safety considerations include contraindications for patients with hypersensitivity to diazoxide or thiazides, monitoring requirements for hyperglycemia, and risks of fluid overload. Common adverse reactions include hypertrichosis, edema, hyperglycemia, and rash.