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Soleno Therapeutics (SLNO) investor relations material
Soleno Therapeutics Jefferies London Healthcare Conference 2025 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Jefferies London Healthcare Conference 2025 summary18 Nov, 2025
Key product and market updates
VYKAT XR, the first FDA-approved drug for Prader-Willi syndrome (PWS), addresses a multi-billion dollar market with high unmet need and robust IP protection into the mid-2030s.
U.S. market is highly concentrated, with about 300 providers treating 4,000 patients and high diagnostic rates due to early genetic testing.
Over 1,000 start forms, 494 unique prescribers, and 764 active patients on drug as of Q3, with an 8% discontinuation rate for adverse events.
More than $130 million lives covered, with reimbursement from commercial, Medicare, Medicaid, and 40 state Medicaid programs.
Accelerated share repurchase program of $100 million announced, with $550 million in cash and Q3 net revenue of $66 million and net income of $26 million.
Clinical and regulatory milestones
Clinical program included a phase III study (C601), open-label extension (C602), and randomized withdrawal, showing significant reduction in hyperphagia.
Withdrawal of drug led to worsening of symptoms, confirming efficacy; side effects were manageable and mostly mild.
VYKAT XR approved for adults and children 4+ with PWS, with ongoing data presentations and advocacy engagement.
European expansion underway, with MAA submission validated and approval decision expected around Q2 next year.
Patent portfolio includes protection through 2035, with potential for further extension.
Community, education, and commercial strategy
Extensive collaboration with advocacy groups, organizing about 60 events and co-developing educational materials.
Broad adoption driven by education, omnichannel outreach, and real-world evidence generation with KOLs.
Support programs include expert-on-demand for providers and caregiver webinars, with strong patient and caregiver engagement.
Nurse educator teams (PACE) assigned to patients for ongoing support and education.
Marketing campaign "Making Space for What Matters" highlights meaningful patient and family outcomes.
Strategy to expand beyond initial 10% US TAM
How will EU market concentration impact launch?
Details on new IP to extend market exclusivity
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Next Soleno Therapeutics earnings date
Piper Sandler 37th Annual Healthcare Conference4 Dec, 2025
Next Soleno Therapeutics earnings date
Piper Sandler 37th Annual Healthcare Conference4 Dec, 2025
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Frequently asked questions
Soleno Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapeutics for the treatment of rare diseases. The company's primary focus is on Prader-Willi Syndrome (PWS), a genetic disorder characterized by chronic hunger, behavioral problems, and other severe health issues. Soleno's lead product candidate, Diazoxide Choline Extended-Release (DCCR) tablets, is currently undergoing evaluation in a Phase III clinical trial as a potential treatment for PWS. This once-daily oral medication aims to address the disorder's hallmark symptoms and improve patient outcomes. The company is headquartered in Redwood City, California, and its shares are listed on NASDAQ.
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