Soleno Therapeutics Inc - SLNO STOCK NEWS

Soleno Therapeutics (NASDAQ: SLNO) has officially launched VYKAT™ XR (diazoxide choline) extended-release tablets in the U.S. market, with first prescriptions already delivered to patients. The FDA-approved treatment, specifically designed for hyperphagia in Prader-Willi syndrome (PWS) patients aged four and older, received authorization on March 26, 2025.

VYKAT XR stands as the only FDA-approved treatment for hyperphagia, which is the primary cause of mortality in PWS patients. The company reports strong initial interest in the medication and has implemented Soleno ONE™, a comprehensive support program to facilitate access for patients, caregivers, and healthcare providers.

Healthcare professionals can initiate prescriptions through www.VykatXRHCP.com, while support is available via the dedicated hotline 1-833-SOLENO-1.

Soleno Therapeutics (NASDAQ: SLNO) has received FDA approval for VYKAT XR (diazoxide choline), the first approved therapy for treating hyperphagia in adults and children aged 4 and older with Prader-Willi syndrome (PWS). The drug will be available in the U.S. starting April 2025.

The approval was based on a Phase 3 multi-center, randomized, double-blind, placebo-controlled trial where patients who switched to placebo showed significant worsening of hyperphagia compared to those remaining on VYKAT XR. The safety profile was established through four years of data across multiple studies.

The most common adverse reactions (≥10% and 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash. To support patient access, Soleno has launched Soleno One, a comprehensive patient support program accessible through VykatXR.com.

Soleno Therapeutics (NASDAQ: SLNO) provided its Q4 and full-year 2024 financial results, highlighting significant developments for DCCR (diazoxide choline extended-release tablets) in treating Prader-Willi syndrome (PWS). The FDA granted Priority Review and Breakthrough Therapy Designation, with a PDUFA date of March 27, 2025.

Key financial highlights include:

• Cash position of $318.6 million as of December 31, 2024
• Secured up to $200 million loan agreement with Oxford Finance
• Completed $158.7 million public offering at $46.00 per share
• Net loss of $(175.9) million or $(4.38) per share for 2024

The company strengthened its commercial organization for DCCR's anticipated launch, with leadership positions filled and strategic investments in commercial programs underway. R&D expenses increased to $78.6 million and G&A expenses rose to $105.9 million for 2024, including significant non-cash stock-based compensation.

Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company focused on rare disease therapeutics, has announced its participation in two major investor conferences this February. The company will present at the Guggenheim SMID Cap Biotech Conference on February 6, 2025, at 2:00 PM ET in a fireside chat format, and at the Oppenheimer 35th Annual Healthcare Life Sciences Conference on February 11, 2025, at 2:40 PM ET as a corporate presentation.

Both presentations will be available via webcast, with replay options accessible through the Investors section of Soleno's website at www.soleno.life.

Soleno Therapeutics (NASDAQ: SLNO) has secured a $200 million debt financing agreement with Oxford Finance The deal includes an initial draw of $50 million at closing, with an additional $100 million available in three tranches contingent on FDA approval of DCCR for Prader-Willi syndrome and commercial milestones. The remaining $50 million will be available upon mutual consent.

The loan features a 48-month interest-only period and 60-month total term, with possible 12-month extensions if specific milestones are met by September 2026. Interest accrues at 1-month term SOFR plus 5.50%. Following the initial draw, Soleno's pro-forma cash position stands at $334.7 million as of September 30, 2024.

Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company focused on rare disease therapeutics, has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The company's management will engage in a fireside chat on Thursday, December 5, 2024, at 9:00 AM Eastern Time. Interested parties can access both the live audio webcast and replay through the Investors section of Soleno's website at www.soleno.life.

Soleno Therapeutics announced that the FDA has extended the review period for DCCR (diazoxide choline) extended-release tablets for treating Prader-Willi syndrome (PWS) in patients four years and older with hyperphagia. The new PDUFA target action date is pushed back by three months to March 27, 2025. The extension follows the FDA's determination that responses to recent information requests constituted a major amendment to the NDA. The FDA did not cite any safety, efficacy, or manufacturing concerns. The drug has received Breakthrough, Fast Track, and Orphan Drug Designations.

Soleno Therapeutics (NASDAQ: SLNO) announced two upcoming oral presentations at the 62nd Annual European Society for Paediatric Endocrinology Meeting 2024 in Liverpool, UK. The presentations will showcase data from their DCCR clinical development program for Prader-Willi syndrome (PWS) treatment. The first presentation focuses on food control parameters and hyperphagia reduction, while the second discusses long-term efficacy results from the DESTINY PWS and C602 studies. PWS affects one in 15,000 live births, with hyperphagia as its hallmark symptom, causing intense hunger and food-seeking behavior. Currently, there are no approved therapies for PWS's hyperphagia, metabolic, cognitive, or behavioral aspects.

Soleno Therapeutics (NASDAQ: SLNO) reported key developments in Q3 2024, including FDA acceptance of their New Drug Application for DCCR tablets treating Prader-Willi syndrome, with Priority Review and a PDUFA date of December 27, 2024. The company reported a net loss of $76.6 million ($1.83 per share) compared to $10.9 million in Q3 2023. R&D expenses were $30.1 million, while G&A expenses reached $49.2 million. The company maintains a strong balance sheet with $284.7 million in cash and equivalents, preparing for potential commercial launch.