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 (NASDAQ: SLNO) will host a webinar on May 24, 2021, at the 23rd European Congress of Endocrinology, focusing on DCCR (diazoxide choline) Extended-Release tablets for treating Prader-Willi syndrome (PWS). Key opinion leaders from the UK and France will discuss results from the DESTINY PWS Phase 3 study. PWS affects 1 in 15,000 births, causing severe hyperphagia, which significantly impacts patients' quality of life. Currently, no approved therapies exist for PWS symptoms. DCCR has received Orphan Drug and Fast Track Designations in the U.S. and EU.
Soleno Therapeutics, Inc. (NASDAQ: SLNO) will present a corporate overview at the Oppenheimer Rare & Orphan Disease Summit on May 21, 2021, at 1:15 PM ET. CEO Anish Bhatnagar will lead the presentation, highlighting the company's focus on developing novel therapeutics for rare diseases, particularly its lead candidate, DCCR extended-release tablets, aimed at treating Prader-Willi Syndrome (PWS) in Phase 3 clinical trials. A live audio webcast will be available on the company’s website.
Soleno Therapeutics (NASDAQ: SLNO) reported Q1 2021 results, showing a net loss of $9.0 million ($0.11 per share), compared to a $5.9 million loss in Q1 2020. R&D expenses rose to $7.2 million from $6.7 million, driven by the DCCR program for Prader-Willi Syndrome (PWS). The company is engaging with the FDA on regulatory steps for DCCR and shared positive behavioral outcomes data from ongoing studies. Cash available was about $41.6 million as of March 31, 2021. Soleno aims to submit a marketing application for DCCR as it continues to develop treatments for rare diseases.
Soleno Therapeutics (NASDAQ: SLNO) announced positive behavioral outcomes from its ongoing open-label extension study of DCCR for Prader-Willi Syndrome (PWS) at the Pediatric Academic Societies Annual Meeting. The study analyzed 48 caregiver interviews, revealing 39 behavioral outcomes across seven domains. Notably, 83% reported positive behavior changes with DCCR. The data underlines DCCR's potential as a safe treatment for PWS, addressing significant behavioral issues linked to the disorder. The company aims to collaborate with the FDA on the path forward for DCCR.
Soleno Therapeutics (NASDAQ: SLNO) announced CEO Anish Bhatnagar's participation in a Prader-Willi Syndrome (PWS) DCCR Town Hall on April 14, 2021. The event highlighted the unmet medical needs of PWS patients and the company's commitment to obtaining regulatory approval for DCCR. Bhatnagar discussed insights from the Foundation for Prader-Willi Research regarding patient experiences in clinical trials. DCCR, a novel treatment for PWS, is currently in Phase 3 trials and has received Orphan Drug and Fast Track Designation in the U.S. and EU.
Soleno Therapeutics (NASDAQ: SLNO) announced that CEO Anish Bhatnagar will participate in a fireside chat at the 31st Annual Oppenheimer Healthcare Conference on March 16, 2021, at 1:50 PM ET. The live audio webcast and replay will be available on the company's website.
Soleno focuses on novel therapeutics for rare diseases, with its lead candidate, DCCR extended-release tablets, under Phase 3 development for Prader-Willi Syndrome. For further details, visit www.soleno.life.
Soleno Therapeutics, Inc. (NASDAQ: SLNO) announced an update regarding its DCCR (diazoxide choline) extended-release tablets for Prader-Willi Syndrome (PWS). Following a recent FDA interaction, Soleno submitted additional analyses from its Phase 3 DESTINY PWS trial, which indicated statistically significant improvements. However, the FDA has mandated an additional controlled clinical trial before proceeding with a New Drug Application (NDA). Soleno remains committed to expediting DCCR’s approval process, recognizing DCCR's potential in treating PWS, a rare disease affecting one in 15,000 live births in the U.S.
Soleno Therapeutics (NASDAQ: SLNO) released its Q4 and FY 2020 financial results, highlighting progress in its Phase 3 DESTINY PWS study for the treatment of Prader Willi Syndrome (PWS) with DCCR tablets. The study showed significant improvements in hyperphagia and other key metrics pre-COVID-19. Financially, Q4 net loss narrowed to $2.8 million from $14.6 million YoY. R&D expenses rose to $5.6 million, and total cash stood at $49.2 million by year-end. The company is also collaborating with Vanderbilt University to explore new treatment options.
Soleno Therapeutics (NASDAQ: SLNO) announced a collaboration with Vanderbilt University to develop novel KATP channel activators aimed at treating rare diseases. The collaboration will be led by Dr. Craig Lindsley and Dr. Jerod Denton, who will leverage their expertise to develop potential new therapeutics. Soleno's lead candidate, DCCR, has shown promise in Phase 3 trials for Prader-Willi syndrome. The partnership aims to create robust tools for identifying these activators, with expectations to advance successful candidates into clinical trials.
Soleno Therapeutics (NASDAQ: SLNO) hosted a webinar on February 5, 2021, to discuss the progress of its Phase 3 clinical trial for Diazoxide Choline Controlled Release (DCCR) tablets aimed at treating Prader-Willi Syndrome (PWS). The analysis showed statistically significant improvements in the primary and key secondary endpoints before the COVID-19 pandemic. DCCR treatment resulted in a notable decrease in hyperphagia, improving patient lives. The company continues to engage with regulatory authorities as it advances its PWS program.
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