Welcome to our dedicated page for Soleno Therapeutics news (Ticker: SLNO), a resource for investors and traders seeking the latest updates and insights on Soleno Therapeutics stock.
News about Soleno Therapeutics, Inc. (NASDAQ: SLNO) centers on its work as a biopharmaceutical company developing and commercializing novel therapeutics for rare diseases, with a primary focus on Prader-Willi syndrome (PWS) and hyperphagia. Company press releases highlight clinical, regulatory, commercial, and corporate developments related to its first commercial product, VYKAT XR (diazoxide choline) extended-release tablets.
Readers following SLNO news can find updates on VYKAT XR, a once-daily oral treatment indicated for hyperphagia in adults and pediatric patients 4 years of age and older with PWS. News items include details of the Phase 3 clinical program, such as the randomized withdrawal study published in the Journal of Clinical Endocrinology and Metabolism, which Soleno reports supported FDA approval as the first treatment for hyperphagia in people living with PWS.
Soleno’s news flow also covers financial results and launch metrics for VYKAT XR, including product revenue from U.S. sales, patient start forms, prescriber adoption, coverage levels, and commentary on achieving profitability and positive cash flow. Investors can track announcements about preliminary and full-quarter results, conference call schedules, and corporate presentations.
Additional news topics include capital allocation and corporate actions, such as the Board-authorized $100 million accelerated share repurchase agreement, amendments to loan facilities, and Board and Audit Committee changes. The company also issues communications on safety and regulatory matters, including an 8-K describing a serious adverse event reported in the FDA’s FAERS database and Soleno’s assessment of that case.
For those monitoring SLNO, this news stream provides insight into Soleno’s rare disease strategy, the commercial trajectory of VYKAT XR in PWS, and key corporate and regulatory milestones disclosed through press releases and SEC-referenced communications.
Soleno Therapeutics announced that data from the randomized withdrawal period of Study C602, focusing on DCCR (diazoxide choline) extended-release tablets in Prader-Willi Syndrome (PWS), will be presented at ENDO 2024. The presentation will occur on June 2, 2024, at the Annual Meeting of the Endocrine Society in Boston.
The study's results indicate that withdrawing DCCR worsens hyperphagia (excessive hunger) and increases weight and BMI in patients with PWS. The presentation, titled 'Withdrawal of DCCR (Diazoxide Choline) Extended-Release Tablets Worsens Hyperphagia and Increases Weight and BMI in a 16-week Double-blind, Placebo-controlled, Randomized Withdrawal Period in Patients with Prader Willi Syndrome,' will be delivered by Dr. Evelien Gevers from Barts Health NHS Trust and Queen Mary University London.
Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company, announced CEO Anish Bhatnagar will participate in two upcoming investor conferences. The Jefferies Global Healthcare Conference is set for June 5, 2024, at 11:30 AM ET, and the Goldman Sachs 45th Annual Global Healthcare Conference on June 11, 2024, at 4:00 PM ET. Live audio webcasts and replays will be available on the company's website.
On May 15, 2024, Soleno Therapeutics launched an initiative in honor of Prader-Willi Syndrome (PWS) Awareness Day. PWS is a genetic disease affecting one in 15,000 births globally, characterized by symptoms like hypotonia, hyperphagia, and intellectual disability. The campaign features a Times Square billboard showcasing nearly 100 individuals from the PWS community. A new website, www.Support4PWS.com, aims to boost awareness and support. CEO Dr. Anish Bhatnagar emphasized the company's commitment to the PWS community. The initiative aligns with May being PWS Awareness Month and National PWS Awareness Day on May 15.
Soleno Therapeutics provided a corporate update and reported its first-quarter financial results for 2024. The company closed a public offering, received Breakthrough Therapy Designation from the FDA for Diazoxide Choline Extended-Release for Prader-Willi syndrome, planned an NDA submission for mid-2024, published a peer-reviewed paper, and expanded its leadership team. Financially, Soleno had significant cash reserves, with increased research and development expenses, higher general and administrative expenses, and obligations for future commercial milestones. The net loss for the quarter was $21.4 million.
Soleno Therapeutics, Inc. announced a public offering of 3,000,000 shares of common stock at $46.00 per share, expected to yield approximately $138.0 million in gross proceeds. The company granted the underwriters a 30-day option to purchase up to 450,000 additional shares. The offering is set to close around May 7, 2024, with plans to utilize the proceeds for research and development of DCCR tablets for Prader-Willi Syndrome treatment, and general corporate purposes.
Soleno Therapeutics, a clinical-stage biopharmaceutical company, announced a proposed public offering of common stock. The company intends to offer shares to fund research and development efforts, including advancing DCCR tablets for the treatment of Prader-Willi Syndrome. The offering is subject to market conditions, with the net proceeds to be used for various corporate purposes.
Soleno Therapeutics announced the publication of a comparison study showing significant improvements in hyperphagia and PWS-related behaviors with DCCR treatment for Prader-Willi syndrome. The study demonstrated positive results from the Phase 3 trials, indicating the potential of DCCR to enhance the quality of life for PWS patients.
Soleno Therapeutics has received Breakthrough Therapy Designation from the U.S. FDA for DCCR in Prader-Willi Syndrome (PWS), marking the first ever for a drug developed for PWS. The designation is based on Phase 3 data, with plans for an NDA submission in mid-2024.
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