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.
Soleno Therapeutics Inc (SLNO) is a clinical-stage biopharmaceutical company pioneering treatments for rare diseases, with a focus on Prader-Willi Syndrome (PWS). This page provides investors and healthcare professionals with authoritative updates on the company’s lead candidate DCCR, regulatory progress, and strategic initiatives.
Access timely press releases and curated news about clinical trial developments, FDA designations, and research breakthroughs. Our coverage spans key areas including Phase 3 trial updates, patent filings, and partnership announcements related to metabolic disorder therapeutics.
Bookmark this page for structured access to Soleno’s latest scientific advancements and corporate communications. Check regularly for verified information about DCCR’s extended-release formulation and its potential impact on PWS management.
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.
Soleno Therapeutics (NASDAQ: SLNO) has officially launched VYKAT™ XR (diazoxide choline) extended-release tablets in the U.S. market, with first prescriptions already delivered to patients. The FDA-approved treatment, specifically designed for hyperphagia in Prader-Willi syndrome (PWS) patients aged four and older, received authorization on March 26, 2025.
VYKAT XR stands as the only FDA-approved treatment for hyperphagia, which is the primary cause of mortality in PWS patients. The company reports strong initial interest in the medication and has implemented Soleno ONE™, a comprehensive support program to facilitate access for patients, caregivers, and healthcare providers.
Healthcare professionals can initiate prescriptions through www.VykatXRHCP.com, while support is available via the dedicated hotline 1-833-SOLENO-1.
Soleno Therapeutics (NASDAQ: SLNO) has received FDA approval for VYKAT XR (diazoxide choline), the first approved therapy for treating hyperphagia in adults and children aged 4 and older with Prader-Willi syndrome (PWS). The drug will be available in the U.S. starting April 2025.
The approval was based on a Phase 3 multi-center, randomized, double-blind, placebo-controlled trial where patients who switched to placebo showed significant worsening of hyperphagia compared to those remaining on VYKAT XR. The safety profile was established through four years of data across multiple studies.
The most common adverse reactions (≥10% and 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash. To support patient access, Soleno has launched Soleno One, a comprehensive patient support program accessible through VykatXR.com.
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