Soleno Therapeutics

Soleno Therapeutics

SLNO
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SLNO · Stock Price

USD 52.95-23.83 (-31.04%)
Market Cap: $2.8B

Historical price data

Market Cap: $2.8BPipeline: 6 drugs (4 Phase 3)Patents: 3Founded: 2017HQ: Redwood City, United States

Overview

Soleno Therapeutics is a mission-driven biopharmaceutical company focused on transforming the treatment landscape for rare genetic disorders. Its key achievement is the FDA approval and commercial launch of VYKAT XR (setmelanotide), the first and only therapy indicated for hyperphagia in Prader-Willi syndrome, marking its transition to a revenue-generating entity. The company's strategy leverages deep expertise in rare disease development and commercialization to maximize the potential of VYKAT XR while exploring its application in other indications within its core competency of melanocortin-4 receptor (MC4R) pathway disorders.

Rare Genetic DisordersGenetic Obesity DisordersPrader-Willi Syndrome

Technology Platform

An integrated development and commercialization platform specialized for rare genetic disorders, with core expertise in targeting the melanocortin-4 receptor (MC4R) pathway to address hyperphagia and severe obesity.

Pipeline

6
6 drugs in pipeline4 in Phase 3
DrugIndicationStageWatch
DCCRPrader-Willi SyndromePhase 3
DCCR + DCCR + Placebo for DCCRPrader-Willi SyndromePhase 3
DCCRPrader-Willi SyndromePhase 3
DCCR + Placebo for DCCRPrader-Willi SyndromePhase 3
DCCR (diazoxide choline) extended-release tabletsSH2B1 Deficiency ObesityPhase 2

FDA Approved Drugs

1
VYKAT XRNDAMar 26, 2025

Opportunities

Significant near-term opportunity lies in capturing the untreated market for hyperphagia in Prader-Willi syndrome with its first-in-class therapy.
Medium-term growth can be driven by label expansion into other rare genetic obesities like Bardet-Biedl Syndrome and the larger hypothalamic obesity population, leveraging the same core asset and commercial expertise.

Risk Factors

The company faces concentrated risk on the successful commercial uptake of its single product, VYKAT XR.
Clinical and regulatory risks remain for pipeline expansion programs, and the company remains susceptible to orphan drug pricing pressures and potential future competition.

Competitive Landscape

VYKAT XR holds a first-mover advantage with no approved competitors for hyperphagia in PWS. Competition consists of off-label therapies and earlier-stage clinical candidates. In other indications, competition is sparse, primarily from generic obesity drugs not tailored to rare genetic forms.