Soleno Therapeutics Stock Price, News & Analysis

Soleno Therapeutics, Inc. (NASDAQ: SLNO) is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. According to the company’s public disclosures and news releases, Soleno’s work centers on addressing significant unmet medical needs in rare genetic conditions, with a particular emphasis on Prader-Willi syndrome (PWS) and its hallmark symptom, hyperphagia.

Soleno’s first commercial product is VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR. Company materials describe VYKAT XR as a once-daily oral treatment for hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome. VYKAT XR was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025, and is commercially available to patients in the United States. Soleno reports that VYKAT XR is the first FDA-approved treatment for hyperphagia in people living with PWS.

Business focus and therapeutic area

Soleno characterizes itself as a company developing therapeutics for rare diseases. Its current commercial and clinical activities highlighted in recent press releases are concentrated on PWS, a rare genetic neurodevelopmental disorder. The company’s disclosures explain that PWS is caused by an abnormality in gene expression on chromosome 15 and occurs in an estimated one in every 15,000 live births, based on data from the Prader-Willi Syndrome Association USA.

The company emphasizes hyperphagia as the defining symptom of PWS. Hyperphagia is described as a chronic and life‑threatening condition marked by an intense, persistent sensation of hunger, food preoccupations, an extreme drive to consume food, food‑related behavior problems, and a lack of normal satiety. Company materials note that hyperphagia can severely diminish quality of life for individuals with PWS and their families and can contribute to serious outcomes, including mortality and longer‑term comorbidities such as diabetes, obesity, and cardiovascular disease.

VYKAT XR and its clinical program

Soleno’s public communications state that VYKAT XR is a proprietary extended‑release formulation of diazoxide choline and that it is administered once daily. The company reports that VYKAT XR’s approval was supported by a comprehensive Phase 3 clinical program in PWS, including placebo‑controlled and long‑term open‑label studies and a 16‑week randomized withdrawal study (C602‑RWP). In this withdrawal study, participants who were switched from VYKAT XR (also referred to as diazoxide choline extended‑release tablets or DCCR) to placebo experienced a statistically significant worsening of hyperphagia scores compared with those who remained on treatment.

According to Soleno’s summary of the JCEM publication, the randomized withdrawal study included individuals 4 years and older with hyperphagia due to PWS who had previously completed earlier Phase 3 studies. The primary endpoint was change from baseline in the Hyperphagia Questionnaire for Clinical Trials (HQ‑CT) total score, with secondary endpoints including Clinical Global Impression of Severity and Improvement. Exploratory endpoints included weight and body mass index (BMI) z‑score. The company reports that adverse events were similar between treatment arms, with no serious adverse events in the DCCR treatment arm and no discontinuations due to adverse events in that study.

Indication and safety information for VYKAT XR

Across multiple press releases, Soleno reiterates the indication for VYKAT XR: treatment of hyperphagia in adults and pediatric patients 4 years of age and older with PWS. The company also summarizes key elements of the product’s Important Safety Information as presented in its communications:

• Contraindications: Use of VYKAT XR is contraindicated in patients with known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides.
• Hyperglycemia: Hyperglycemia, including diabetic ketoacidosis, has been reported. Company materials state that fasting plasma glucose (FPG) and HbA1c should be tested before initiating VYKAT XR, that blood glucose should be optimized in patients who have hyperglycemia, and that fasting glucose and HbA1c should be monitored during treatment, with more frequent monitoring early in therapy for patients with risk factors for hyperglycemia.
• Risk of fluid overload: Edema, including severe reactions associated with fluid overload, has been reported. The company advises monitoring for signs or symptoms of edema or fluid overload and notes that VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients.
• Common adverse reactions: The most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) reported in company materials include hypertrichosis, edema, hyperglycemia, and rash.

Soleno’s communications direct readers to the full Prescribing Information, including Medication Guide, for complete safety and dosing details.

Commercialization and financial milestones

Soleno reports that VYKAT XR was launched commercially in the United States following FDA approval. In its public financial updates, the company has highlighted product revenue from U.S. sales of VYKAT XR and related operating metrics, such as patient start forms, unique prescribers, coverage levels, and active patients on therapy. The company has also disclosed that it achieved profitability and positive cash flow following the launch of VYKAT XR, based on its reported financial results.

In addition, Soleno’s Board of Directors authorized a $100 million accelerated share repurchase (ASR) program, as described in an 8‑K filing and related press release. Under the ASR Agreement with Jefferies LLC, Soleno prepaid the purchase price and received an initial delivery of shares, with the final number of shares to be determined based on the volume‑weighted average price of its common stock over the term of the transaction, subject to agreed terms and adjustments. The company also entered into a first amendment to its loan agreement with Oxford Finance LLC and lenders to, among other things, permit the ASR and modify the availability of certain term loans.

Regulatory and safety communications

Through an 8‑K filed under Regulation FD, Soleno disclosed that it became aware of a serious adverse event reported in the FDA’s Adverse Event Reporting System involving a patient who died from an apparent pulmonary embolus. The company reports that the treating physician assessed the case as not related to treatment with VYKAT XR and that Soleno’s assessment is the same. In that disclosure, the company reiterates that VYKAT XR was approved following a rigorous clinical program and that it is committed to reporting adverse events in accordance with applicable law. Soleno also references FDA statements that reports in FAERS do not establish causation and may reflect underlying disease or other factors.

Corporate governance and investor relations

Soleno’s SEC filings and press releases describe ongoing corporate governance developments, including the appointment of an additional independent director with extensive biopharmaceutical finance experience to its Board and Audit Committee. The company also notes the passing of a long‑serving Board member who chaired its Audit Committee and indicates that another Board and Audit Committee member is expected to assume the role of Audit Committee Chair.

The company regularly participates in healthcare and investor conferences and hosts earnings calls and webcasts to discuss financial results and operational updates. These activities are disclosed in 8‑K filings and press releases and are part of the company’s communication with existing and potential investors.

Stock listing and regulatory status

According to recent 8‑K filings, Soleno Therapeutics’ common stock trades on the NASDAQ under the symbol SLNO. The filings list the company’s common stock, $0.001 par value, as registered under Section 12(b) of the Securities Exchange Act of 1934. The filings also reference the company’s loan agreements, equity incentive plans, and other corporate documents as exhibits.

Industry classification

For industry classification purposes, Soleno is described in the provided data as operating within Surgical and Medical Instrument Manufacturing in the Manufacturing sector, while its own disclosures consistently describe it as a biopharmaceutical company focused on rare diseases. Its primary publicly discussed activities involve pharmaceutical development, clinical research, regulatory interactions, and commercialization of a prescription medicine for a rare genetic disorder.

FAQs about Soleno Therapeutics, Inc. (SLNO)

• What does Soleno Therapeutics, Inc. do?
  Soleno Therapeutics, Inc. is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. Its public communications highlight work in Prader‑Willi syndrome and the commercialization of VYKAT XR for hyperphagia in PWS.
• What is VYKAT XR?
  VYKAT XR (diazoxide choline) extended‑release tablets, formerly known as DCCR, is Soleno’s first commercial product. It is a once‑daily oral treatment indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader‑Willi syndrome.
• When was VYKAT XR approved by the FDA?
  Company press releases state that VYKAT XR was approved by the U.S. Food and Drug Administration on March 26, 2025, and is commercially available to patients in the United States.
• What condition does Soleno primarily focus on?
  Soleno’s recent disclosures focus on Prader‑Willi syndrome, a rare genetic neurodevelopmental disorder. The company emphasizes hyperphagia, the hallmark symptom of PWS, as the primary target of its commercial product VYKAT XR.
• How does Soleno describe Prader‑Willi syndrome (PWS)?
  Soleno describes PWS as a rare genetic neurodevelopmental disorder caused by an abnormality in gene expression on chromosome 15. It cites estimates that PWS occurs in about one in every 15,000 live births and notes that hyperphagia is the defining symptom, associated with serious health risks and reduced quality of life.
• What safety information has Soleno disclosed about VYKAT XR?
  Company materials list contraindications in patients with hypersensitivity to diazoxide, other components of VYKAT XR, or thiazides. They highlight warnings regarding hyperglycemia, including diabetic ketoacidosis, and risk of fluid overload and edema, and identify common adverse reactions such as hypertrichosis, edema, hyperglycemia, and rash.
• On which exchange does SLNO trade?
  According to Soleno’s 8‑K filings, the company’s common stock is listed on the NASDAQ under the trading symbol SLNO.
• What financial steps has Soleno taken related to its stock?
  An 8‑K filing and related press release describe an accelerated share repurchase agreement with Jefferies LLC for up to $100 million of Soleno’s common stock, authorized by the company’s Board of Directors.
• How does Soleno communicate with investors?
  Soleno issues press releases and files current reports on Form 8‑K to announce financial results, preliminary operating metrics, participation in investor conferences, corporate presentations, and material agreements, and it hosts conference calls and webcasts for earnings and business updates.
• Is Soleno involved in any other rare diseases beyond PWS?
  The company broadly states that it is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. In the provided materials, its detailed disclosures and commercial activities center on Prader‑Willi syndrome and hyperphagia.