Soleno Therapeutics

Soleno Therapeutics

Clinical-stage biopharma developing rare-disease therapies

Overview

Soleno Therapeutics develops and commercializes treatments for rare diseases, with a focus on Prader-Willi syndrome (PWS) and other rare endocrine disorders. Its lead product, DCCR (Diazoxide Choline Extended Release) tablets, is an oral once-daily medicine designed for its target conditions; the exact biological mechanism is not detailed in the provided information. The company differentiates itself by concentrating on a narrow, underserved niche in biopharma and pursuing regulatory designations like Orphan Drug and FDA Fast Track to help bring treatments to market. Soleno’s goal is to advance its research pipeline and obtain regulatory approval to deliver therapies that can improve outcomes for patients and families affected by rare endocrine disorders.

Significant Headcount Growth

About Soleno Therapeutics

Simplify's Rating
Why Soleno Therapeutics is rated
B-
Rated A on Competitive Edge
Rated B on Growth Potential
Rated D+ on Differentiation

Industries

Biotechnology

Healthcare

Company Size

51-200

Company Stage

IPO

Headquarters

Redwood City, California

Founded

1999

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Simplify's Take

What believers are saying

  • VYKAT XR generated $190.4 million in 2025 revenue and $91.7 million in Q4.
  • By February 2026, Soleno reported 1,250 start forms and 630 prescribers.
  • Neurocrine's April 6, 2026 deal delivered $53 cash per share immediately.

What critics are saying

  • Reuters reported seven death reports and FDA surveillance concerns on August 12, 2026.
  • PWS families allege edema, respiratory, and cardiac harm, feeding class-action litigation through 2026.
  • Any confirmed causal safety signal would crush VYKAT XR adoption and Neurocrine's rare-disease thesis.

What makes Soleno Therapeutics unique

  • VYKAT XR became the first FDA-approved hyperphagia treatment for Prader-Willi syndrome in March 2025.
  • Mid-2040s patent protection and orphan exclusivity shield the drug's niche endocrine franchise.
  • Acquisition by Neurocrine on May 18, 2026 validated VYKAT XR's commercial platform.

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Funding

Total Funding

$698.5M

Above

Industry Average

Funded Over

7 Rounds

Acquisition funding comparison data is currently unavailable. We're working to provide this information soon!
Acquisition Funding Comparison
Coming Soon

Stock Price

Growth & Insights and Company News

Headcount

6 month growth

8%

1 year growth

6%

2 year growth

9%
Insider Monkey
Jul 14th, 2026
Ovid Therapeutics (OVID) appoints kevin Norrett as chief business officer.

Ovid Therapeutics (OVID) appoints kevin Norrett as chief business officer. Published on July 14, 2026 at 6:33 am by jeff lewis in news. On July 8, 2026, Ovid Therapeutics Inc. (NASDAQ:OVID) announced several strategic appointments. Kevin Norrett will join Ovid as chief business officer to lead business and corporate development functions, as well as strategic partnerships. Most recently, Norrett served as chief business officer at Soleno Therapeutics. Ovid also promoted Charles Carter to CFO, where Carter will lead business and financial operations. Carter succeeds Jeffrey Rona, who will remain a long-term advisor to the company through 2027. Victoria Fort was promoted to chief strategy officer, leading enterprise strategy, investor relations, and operational growth initiatives. In May, Ovid Therapeutics reported Q1 EPS of (12c), compared with the consensus of (11c). CEO Meg Alexander said the first quarter reflected "focused execution" and continued progress across the company's pipeline of small molecule medicines for intractable brain conditions. Alexander said development programs remain on track, the clinical organization has expanded, and the company expects to be well capitalized into 2029. Ovid Therapeutics Inc. (NASDAQ:OVID) develops small-molecule medicines for brain disorders, including epilepsies and seizure-related neurological disorders in the United States. While we acknowledge the risk and potential of OVID as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. If you are looking for an AI stock that is more promising than OVID and that has 10,000% upside potential, check out our report about the cheapest AI stock.

Sangamon Sun
Jun 15th, 2026
Soleno Therapeutics presents data on VYKAT XR for Prader-Willi syndrome at ENDO 2026.

Soleno Therapeutics presents data on VYKAT XR for Prader-Willi syndrome at ENDO 2026. Soleno Therapeutics, a Neurocrine Biosciences company, announced on June 15 new late-breaking data at ENDO 2026 showing that resuming treatment with VYKAT XR (diazoxide choline) extended-release tablets for two years after a 16-week randomized withdrawal period was associated with durable improvements in hyperphagia and behavioral symptoms in individuals with Prader-Willi syndrome. Sanjay Keswani, M.D., Chief Medical Officer of Neurocrine Biosciences, said, "These compelling data further reinforce our confidence in VYKAT XR as a safe and effective long-term treatment for hyperphagia in individuals four years of age and older living with Prader-Willi syndrome. Individuals who resumed treatment following the randomized withdrawal period achieved durable improvements in hyperphagia and other PWS-related behaviors. This completes the presentation of data from our comprehensive Phase 3 development program and further confirms the long-term benefit of VYKAT XR for people living with PWS." The Phase 3 development program included Study C614, an open-label long-term extension study enrolling 77 participants. The study assessed whether those who had received placebo during the withdrawal period could regain benefit after restarting VYKAT XR and whether those who remained on continuous therapy maintained improvement over time. Hyperphagia was measured using the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), while behavioral symptoms were assessed by the PWS Profile questionnaire (PWSP). Results showed that participants resuming VYKAT XR experienced recovery of benefit, while those continuing therapy maintained improvements. Additional presentations compared outcomes from VYKAT XR-treated participants to natural history controls from the PATH for PWS Natural History Study. Over three years, statistically significant and sustained improvements were observed in hyperphagia scores at all evaluated time points (p<0.0001), with consistent benefits also reported across six behavioral domains such as anxiety, rigidity/irritability, compulsivity, aggressive behaviors, disordered thinking, and depression. Prader-Willi syndrome is described as a rare genetic neurodevelopmental disorder caused by abnormal gene expression on chromosome 15. The main symptom is hyperphagia - a persistent sensation of hunger leading to food preoccupations - which can severely affect quality of life and lead to additional health complications including diabetes or cardiovascular disease. VYKAT XR was approved by the U.S. Food and Drug Administration on March 26, 2025, for treating hyperphagia in adults and pediatric patients aged four years or older with Prader-Willi syndrome. Important safety information includes contraindications related to hypersensitivity to diazoxide or thiazides; warnings about risks such as hyperglycemia or fluid overload; monitoring recommendations; and common adverse reactions like hypertrichosis or edema.

Gulf & Main Magazine
Apr 6th, 2026
Neurocrine acquires Soleno for $2.9B, adding first FDA-approved PWS hyperphagia treatment VYKAT XR

Neurocrine Biosciences has agreed to acquire Soleno Therapeutics for $53 per share in cash, representing a total equity value of $2.9 billion. The deal adds VYKAT XR, the first FDA-approved treatment for hyperphagia in Prader-Willi syndrome, to Neurocrine's portfolio. VYKAT XR launched in the second quarter of 2025 and generated $190 million in revenue during its first year, including $92 million in the fourth quarter. The acquisition expands Neurocrine's commercial portfolio to three first-in-class medicines and establishes a platform for long-term growth, supported by intellectual property extending into the mid-2040s. The deal, approved by both boards, will be funded with cash and modest debt. The transaction is expected to close within 90 days, subject to regulatory approvals and customary conditions.

MarketScreener
Apr 6th, 2026
Neurocrine to Acquire Soleno Therapeutics, Expanding Its Endocrinology and Rare Disease Portfolio

(Nasdaq: NBIX) and Soleno Therapeutics, Inc. (Nasdaq: SLNO) today announced that Neurocrine has entered into a definitive agreement to acquire Soleno for $53.00 per share in cash, representing a total transaction equity value of $2.9 billion.

Seeking Alpha
Apr 6th, 2026
Neurocrine nears $2.5B-plus deal to buy Soleno Therapeutics - FT (NBIX:NASDAQ)

Neurocrine Biosciences is in talks to buy Soleno Therapeutics, valuing the maker of the first commercialized drug to treat extreme hunger caused by Prader-Willi syndrome at more than $2.5B.

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