Soleno Therapeutics

SLNOApproved

Redwood City, United StatesFounded 2017soleno.life

Soleno Therapeutics is a Redwood City, California-based biopharmaceutical company dedicated to addressing unmet medical needs in rare genetic disorders. The company achieved a major milestone with the FDA approval and commercialization of VYKAT XR for hyperphagia in Prader-Willi syndrome, establishing its first commercial product. With experienced leadership that includes executives who have successfully guided companies through product launches and acquisitions, Soleno is positioned to build on its initial success and expand its rare disease portfolio. The company operates as a public entity (NASDAQ: SLNO) with a market valuation reflecting its commercial-stage status.

Market Cap

$1.7B

Founded

2017

Focus

Small Molecules

SLNO · Stock Price

USD 33.22+28.74 (+640.69%)

Historical price data

AI Company Overview

Pipeline Snapshot

6 drugs in pipeline, 4 in Phase 3

Drug	Indication	Stage
DCCR	Prader-Willi Syndrome	Phase 3
DCCR + DCCR + Placebo for DCCR	Prader-Willi Syndrome	Phase 3
DCCR	Prader-Willi Syndrome	Phase 3
DCCR + Placebo for DCCR	Prader-Willi Syndrome	Phase 3
DCCR (diazoxide choline) extended-release tablets	SH2B1 Deficiency Obesity	Phase 2

FDA Approved Drugs

VYKAT XRNDAMar 26, 2025

Opportunities

Soleno's primary growth opportunity lies in maximizing the commercial potential of VYKAT XR for Prader-Willi syndrome and potentially expanding its label.

Further opportunities include leveraging its rare disease development and commercial expertise to in-license or acquire additional mid-to-late-stage rare disease assets, building a sustainable portfolio.

The company's experienced leadership in guiding companies to successful acquisitions also presents strategic partnership or exit opportunities.

Risk Factors

Key risks include commercial execution challenges for its first product, heavy reliance on VYKAT XR revenue, potential pricing and reimbursement hurdles in the rare disease space, and the need to successfully develop or acquire additional pipeline candidates to ensure long-term growth.

Competitive Landscape

VYKAT XR currently has no direct FDA-approved competitors for hyperphagia in Prader-Willi syndrome, giving Soleno a first-mover advantage. Broader competition comes from other biopharma companies focused on rare diseases. Soleno differentiates through its specific focus, experienced leadership with rare disease commercialization success, and its established commercial infrastructure.

Publications

Patents

Pipeline

FDA Approvals