Multiple active sites and strong US enrollment continue to support Q3 2026 timing for topline data readout Clinical trial sites in Canada and the United Kingdom have received regulatory clearance to enroll All patients who have completed HERO trial to date have successfully enrolled and remain in the Open Label Extension trial SAN DIEGO, Dec. 10, 2025 (GLOBE NEWSWIRE) -- Aardvark Therapeutics, Inc. (Aardvark) (Nasdaq: AARD), a clinical-stage biopharmaceutical company focused on developing novel, small-mole ...

Core Insights - Soleno Therapeutics presented new data on VYKAT XR (diazoxide choline) extended-release tablets at the 2025 International Prader-Willi Syndrome Conference, highlighting its potential benefits for individuals with Prader-Willi Syndrome (PWS) [1][2] Group 1: Efficacy of VYKAT XR - VYKAT XR significantly reduces hyperphagia symptoms in PWS patients managed with strict food controls, showing statistically significant reductions in HQ-CT Total scores (p ≤ 0.0001) [5] - Participants in highly food-restricted environments benefited from VYKAT XR treatment similarly to those in less restricted environments, indicating broad applicability of the treatment [5] Group 2: Safety and Efficacy in Co-Morbid Conditions - 60% of study participants had evidence of pre-diabetes or diabetes (PD/DM) at baseline, with efficacy outcomes at Week 156 showing similar results for both PD/DM and normoglycemic groups (p<0.0001) [7] - Although a higher proportion of hyperglycemia-related adverse events were reported in the PD/DM group (42.7% vs 24.0%), these events were generally manageable, and treatment discontinuation rates were low (4.0% in PD/DM vs 6.0% in normoglycemic) [8][9] Group 3: Background on Prader-Willi Syndrome - Prader-Willi Syndrome is a rare genetic neurodevelopmental disorder affecting approximately 1 in every 15,000 live births, characterized by hyperphagia, which can lead to severe health complications [10][11] - Hyperphagia in PWS can result in significant mortality and long-term co-morbidities such as diabetes, obesity, and cardiovascular disease [12] Group 4: Product Information - VYKAT XR was approved by the FDA on March 26, 2025, and is indicated for the treatment of hyperphagia in adults and pediatric patients aged 4 years and older with PWS [13][18]