Soleno Therapeutics Inc Stock Price, News & Analysis

Soleno Therapeutics (NASDAQ:SLNO) has announced plans for a $200 million public offering of common stock, with an additional 30-day option for underwriters to purchase up to $30 million of shares. The offering will be managed jointly by Goldman Sachs and Guggenheim Securities.

The proceeds will primarily fund the commercialization of VYKAT™ XR, their recently FDA-approved therapy for hyperphagia in Prader-Willi syndrome. Additional funds will support EU regulatory activities, research and development, and general corporate purposes. The offering will be made through a previously filed Form S-3ASR registration statement.

Soleno Therapeutics (Nasdaq: SLNO) released preliminary Q2 2025 financial results, highlighting strong performance of its recently approved drug VYKAT™ XR. The company projects Q2 net revenue between $31.0-$33.0 million from VYKAT™ XR sales.

Key metrics include $293.8 million in cash and equivalents, 646 patient start forms from 295 unique prescribers since VYKAT™ XR's March 26 approval, and $50.0 million in outstanding debt. The company notes these results are preliminary and subject to final review.

Soleno Therapeutics (NASDAQ: SLNO) announced two presentations featuring their drug VYKAT™ XR (diazoxide choline) for Prader-Willi Syndrome at the upcoming ENDO 2025 conference in San Francisco. The presentations will be delivered by Dr. Ashley Shoemaker from Vanderbilt University Medical Center.

The first presentation will discuss glycemic outcomes of the drug over a 4-year period, scheduled as an oral presentation on July 14, 2025. The second presentation, in poster format, will focus on characterizing peripheral edema in patients during long-term administration over 4.5 years.

Soleno Therapeutics (NASDAQ: SLNO) presented new data on VYKAT XR (diazoxide choline) for Prader-Willi Syndrome (PWS) treatment at the 2025 United in Hope conference. Two key findings were highlighted: First, VYKAT XR showed significant reduction in hyperphagia symptoms (p ≤ 0.0001) in patients under strict food control through Year 3. Second, the drug demonstrated similar efficacy in both pre-diabetic/diabetic and normoglycemic patients at Week 156 (p<0.0001).

The study revealed that 60% of participants had pre-diabetes or diabetes at baseline. While hyperglycemia-related adverse events were higher in the pre-diabetic/diabetic group (42.7% vs 24.0%), they were generally manageable with low discontinuation rates (4.0% vs 6.0%).

Soleno Therapeutics (NASDAQ: SLNO) announced its participation in the 2025 United in Hope: International Prader-Willi Syndrome Conference with one oral and six poster presentations. The conference, scheduled for June 24-28, 2025, in Phoenix, AZ, is a historic collaboration between major PWS organizations and is expected to be the largest PWS-focused conference ever. The presentations focus on the company's DCCR tablets, covering topics including long-term efficacy results, swallowability, hyperphagia reduction, emotional impact, safety in pre-diabetic patients, fat mass changes, and food control parameters. Dr. Anish Bhatnagar, CEO, emphasized the importance of data, science, and advocacy in advancing rare disease treatments, particularly during the 50th anniversary of PWSA | USA.

Soleno Therapeutics (NASDAQ: SLNO) announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for Diazoxide Choline Prolonged-Release Tablets (DCCR) to treat hyperphagia in Prader-Willi syndrome (PWS) patients aged four and older. The treatment, recently approved by the FDA under the brand name VYKAT™ XR in March 2025, targets approximately 9,500 PWS patients across the UK, France, Germany, Italy, and Spain.

The company has received Orphan Drug Designation in the EU, potentially granting up to 10 years of market exclusivity if approved, along with additional regulatory and financial benefits. This validation marks a crucial step in Soleno's mission to provide treatment for PWS patients in the EU.

Soleno Therapeutics (NASDAQ: SLNO), a biopharmaceutical company focused on rare disease therapeutics, has announced its participation in two major healthcare conferences in June 2025:

- Jefferies Global Healthcare Conference: Corporate presentation scheduled for Wednesday, June 4, 2025, at 10:30 AM ET

- Goldman Sachs 46th Healthcare Conference: Corporate presentation scheduled for Tuesday, June 10, 2025, at 8:40 AM ET

Both presentations will be available for replay in the Investors section of Soleno's website.

Soleno Therapeutics (NASDAQ: SLNO) presented clinical data for VYKAT™ XR (diazoxide choline) at the Pediatric Endocrine Society Annual Meeting 2025. The data demonstrated significant improvements in hyperphagia and behavioral symptoms in Prader-Willi Syndrome (PWS) patients after resuming treatment following a withdrawal period.

After approximately 3 years of open-label treatment and a 16-week randomized withdrawal period, patients who restarted VYKAT XR showed notable improvements within 13 weeks. Key findings include a 6.3-point reduction in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score at one year, returning to pre-withdrawal baseline levels. The study also reported improvements across all six behavioral domains assessed.

Soleno Therapeutics (NASDAQ: SLNO) announced upcoming poster presentations for VYKAT™ XR (diazoxide choline) extended-release tablets at the Pediatric Endocrine Society (PES) Meeting 2025. The presentations will focus on the drug's clinical development program for treating hyperphagia associated with Prader-Willi syndrome (PWS). Two posters will be presented by Dr. Jack Yanovski on May 17, 2025. The first presentation examines long-term effects of VYKAT XR on lean body mass in PWS patients. The second discusses improvements in hyperphagia and behavioral symptoms after resuming treatment following a 16-week randomized withdrawal period in Study C614.