Soleno Therapeutics (SLNO)

Executive Summary

Soleno Therapeutics is a commercial-stage biopharmaceutical company focused on rare genetic disorders, with its lead product VYKAT XR (diazoxide choline extended-release) receiving FDA approval for hyperphagia in Prader-Willi syndrome (PWS). The company is transitioning from development to commercial operations, leveraging a patient-centric approach to address unmet needs in orphan diseases. VYKAT XR is the first approved therapy for hyperphagia, a life-threatening symptom of PWS, and its commercial launch is underway. Beyond PWS, Soleno is advancing DCCR in Phase 3 trials (including a long-term open-label extension) and Phase 2 studies for SH2B1 deficiency obesity, a genetic obesity disorder. The pipeline addresses significant unmet needs in rare diseases with high morbidity. With a market cap of ~$2.7 billion, Soleno is positioned to capture value from VYKAT XR's launch. Key catalysts include initial revenue reports, data from the pivotal Phase 3 C602 trial, and potential label expansion.

Upcoming Catalysts (preview)

• Q3 2026VYKAT XR commercial launch and initial revenue reports90% success
• Q4 2026Phase 3 C602 trial (NCT05701774) data readout for DCCR in Prader-Willi Syndrome60% success
• Q4 2026FDA label expansion or pediatric exclusivity decision for VYKAT XR50% success