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.
Soleno Therapeutics, Inc. (symbol: SLNO) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapeutics for the treatment of rare diseases. The company's lead candidate, DCCR (Diazoxide Choline Controlled-Release) Tablets, is a once-daily oral medication currently in its Phase 3 clinical development program for Prader-Willi Syndrome (PWS). PWS is a rare genetic disorder characterized by chronic hunger, leading to severe obesity, among other complications.
Soleno Therapeutics has achieved significant milestones, including the FDA's Breakthrough Therapy Designation for DCCR, indicating promising preliminary data. This designation aims to expedite the development and review process of DCCR, reflecting the drug's potential to offer substantial improvements over existing therapies.
Financially, Soleno is well-positioned, with cash and cash equivalents amounting to approximately $169.7 million as of December 31, 2023, bolstered by a successful public offering and warrant exercises. The company continues to invest significantly in research and development, with expenses reaching $25.2 million for the year ended December 31, 2023, primarily driven by clinical trial costs and manufacturing efforts in preparation for NDA submission.
Soleno's strategic partnerships and acquisitions, including the 2016 merger with Essentialis, have enhanced its pipeline and development capabilities. The company is obligated to pay up to $21.2 million to former Essentialis stockholders upon achieving specific commercial milestones for DCCR sales.
The clinical data supporting DCCR is robust, with extensive research from five Phase 1 studies in healthy volunteers and three Phase 2 studies, including one focused on PWS patients. The data suggests DCCR's potential in addressing hyperphagia, aggressive behaviors, and other metabolic parameters associated with PWS.
With a strengthened leadership team and a clear focus on advancing DCCR through regulatory processes, Soleno Therapeutics aims to provide a new treatment option for PWS patients. For the latest updates and more detailed information, visit the company's official website at www.soleno.life.
Soleno Therapeutics (SLNO) announced a funding agreement with Nantahala Capital, Abingworth, and Vivo Capital, securing up to $60 million. The agreement includes $10 million upfront and additional funds upon achieving positive clinical data for DCCR, its treatment for Prader-Willi Syndrome (PWS). DCCR is in a Phase 3 study targeting hyperphagia, a major symptom of PWS. The funding is set to enhance Soleno’s financial standing and support its New Drug Application submission.
Soleno Therapeutics, Inc. (NASDAQ: SLNO) reported its third quarter 2022 corporate update and financial results. The company initiated a randomized withdrawal period for Study C602, assessing DCCR for Prader-Willi syndrome (PWS), with top-line data expected in the first half of 2023. Financially, cash at quarter-end stood at $19.8 million. Research and development expenses were $3.8 million, down from $5.0 million in 2021. Net loss narrowed to $6.1 million, or $0.76 per share, compared to $8.1 million in the prior year.
Soleno Therapeutics (NASDAQ: SLNO) announced the initiation of a randomized withdrawal period for Study C602, focusing on DCCR (Diazoxide Choline) Extended-Release tablets, aimed at treating Prader-Willi syndrome (PWS). This pivotal phase of the study involves 80 patients across 22 sites, evaluating the drug's efficacy against a placebo. Positive discussions with the FDA suggest that data could support a New Drug Application. DCCR, designed to relieve symptoms of PWS, has received both Orphan Drug and Fast Track designations.
Soleno Therapeutics (NASDAQ: SLNO) announced that CEO Anish Bhatnagar will present a corporate overview at the H.C. Wainwright 24th Global Investment Conference from September 12-14, 2022. The conference will take place virtually and at Lotte New York Palace Hotel. The presentation will be available on-demand starting September 12 at 7:00 a.m. ET. Soleno focuses on developing innovative therapies for rare diseases, with its lead candidate, DCCR, currently in Phase 3 trials for Prader-Willi syndrome.
Soleno Therapeutics (NASDAQ: SLNO) reported second quarter 2022 financial results with a focus on DCCR, its lead product for treating Prader-Willi Syndrome (PWS). The FDA acknowledged that a randomized withdrawal phase of Study C602 could address efficacy concerns for an NDA submission. Cash reserves at June 30, 2022, were $24.1 million, sufficient to fund operations through early 2023. R&D expenses decreased from $5.6 million to $3.7 million year-over-year. The net loss narrowed to $6.7 million, down from $11 million in the same quarter of 2021.
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.
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