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 (NASDAQ: SLNO) announced a significant update regarding its DCCR (diazoxide choline) extended-release tablets for Prader-Willi syndrome. After discussions with the FDA, the company confirmed that data from a proposed randomized withdrawal phase of Study C602 may satisfy the agency's concerns and support a New Drug Application (NDA) submission. This phase will commence shortly, with top-line data anticipated in Q1 2023. DCCR is currently the only candidate targeting hyperphagia associated with PWS, a condition affecting 1 in 15,000 U.S. births.
Soleno Therapeutics (NASDAQ: SLNO) presented key findings at the 11th International Prader-Willi Syndrome Organisation Conference in July 2022. The studies highlighted the long-term safety and efficacy of Diazoxide Choline Extended-Release (DCCR) tablets in patients with Prader-Willi Syndrome (PWS). Analysis of caregiver interviews revealed that over 65% reported positive changes in food-related behaviors, with 88% of participants experiencing improvements across various behavioral domains. DCCR has received Orphan Drug and Fast Track designations, supporting its potential as a therapeutic option for PWS.
Soleno Therapeutics announced positive clinical outcomes for its drug DCCR in treating Prader-Willi syndrome (PWS). Presented at ENDO 2022, findings revealed significant hormonal and cardiometabolic improvements after one year of treatment in 82 patients, including enhanced body composition, reduced leptin levels, and improved insulin sensitivity. Safety data highlighted common adverse events consistent with previous studies. DCCR shows potential as a meaningful therapy for PWS, addressing key symptoms while no approved treatments currently exist for the disorder.
Soleno Therapeutics, Inc. (NASDAQ: SLNO) announced participation in ENDO 2022, taking place June 11-14, 2022, in Atlanta, Georgia. The company will present two significant studies on Diazoxide Choline Extended-Release (DCCR) tablets for Prader-Willi Syndrome (PWS). The first is an oral presentation on hormonal and cardiometabolic changes on June 12, 2022, from 11 AM to 12:30 PM ET, presented by Dr. Eric Felner. The second, a poster session on long-term safety, will also occur on June 12, at 1 PM ET, presented by Dr. Michael Woloschak. Presentation materials will be available on the company's website.
Soleno Therapeutics (NASDAQ: SLNO) will present multiple studies at the 2022 European Congress of Endocrinology in Milan, Italy, from May 21-24. The presentations include updates on the long-term safety of Diazoxide Choline Extended-Release (DCCR) in treating Prader-Willi syndrome (PWS). Key presentations are scheduled for May 21 and May 22, with notable findings by Dr. Evelien Gevers and the DESTINY PWS Investigators. Further details and copies of the posters will be available on Soleno's website post-presentation.
Soleno Therapeutics, a clinical-stage biopharmaceutical firm, announced CEO Anish Bhatnagar will present a corporate overview at the H.C. Wainwright Global Investment Conference from May 23-26, 2022. The presentation will be available on-demand starting May 24 at 7 AM ET on the company’s website. Soleno focuses on developing therapeutics for rare diseases, with its lead candidate, DCCR, a treatment for Prader-Willi syndrome, currently in Phase 3 clinical trials.
Soleno Therapeutics (NASDAQ: SLNO) provided a corporate update and financial results for Q1 2022, reporting a net loss of approximately $5.7 million, down from $9.0 million in Q1 2021. The company is focused on obtaining FDA alignment for a New Drug Application for DCCR, its lead candidate for Prader-Willi Syndrome (PWS). Soleno closed a $15 million public offering, enhancing its financial position with $29 million in cash as of March 31, 2022. R&D expenses decreased to $4 million from $7.2 million, while general and administrative costs also fell.
Soleno Therapeutics (NASDAQ: SLNO) announced effective results from its DESTINY PWS study on diazoxide choline extended-release (DCCR) tablets for Prader-Willi Syndrome (PWS). Key findings presented at two 2022 pediatric meetings show significant reductions in hyperphagia and behavioral issues among patients treated with DCCR over 52 weeks. Statistical improvements were noted in HQ-CT total scores and various behavioral domains (p<0.001). CEO Anish Bhatnagar highlighted confidence in DCCR as a potential treatment, with data submitted to the FDA for a New Drug Application.
Soleno Therapeutics (NASDAQ: SLNO) announced the closing of a public offering, selling 40 million shares at $0.25 each, generating approximately $14.8 million in gross proceeds. Additionally, investors could purchase pre-funded warrants for $0.24 each, allowing for the purchase of 20 million shares. Proceeds will primarily fund research and development for DCCR tablets, aimed at treating Prader-Willi Syndrome (PWS). The offering was registered with the SEC and co-managed by Oppenheimer & Co., Inc. and Laidlaw & Company.
Soleno Therapeutics (NASDAQ: SLNO) announced its fourth quarter and full-year financial results for 2021. The company received FDA meeting minutes regarding data adequacy for a potential NDA submission for DCCR in treating Prader-Willi syndrome (PWS). Soleno plans to initiate a new study with currently enrolled participants. The company closed a $15 million public offering on March 31, 2022. Financially, R&D expenses were $3.8 million for Q4 2021, down from $5.6 million year-over-year, while the net loss for the year increased to $30.9 million from $24.6 million. As of December 31, 2021, cash reserves decreased to $21.3 million.