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) 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.
Soleno Therapeutics, Inc. (NASDAQ: SLNO) will hold a KOL webinar on February 4, 2021, at 12:00 PM ET. The webinar features Dr. Jennifer Miller from the University of Florida discussing treatments for Prader-Willi Syndrome (PWS) and Soleno's Phase III DCCR program, alongside Dr. Theresa Strong from the Foundation for Prader-Willi Research addressing the pandemic's effects on PWS families. This event aims to update stakeholders on ongoing clinical trials and research developments.
Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company, announced a corporate overview presentation at the H.C. Wainwright Virtual BioConnect 2021 Conference from January 11-14, 2021. The presentation will be available on-demand starting January 11, 2021, on the company’s website, www.soleno.life. Soleno is focused on developing novel therapeutics for rare diseases, with its lead candidate, DCCR, targeting Prader-Willi Syndrome.
Soleno Therapeutics plans to submit analyses of clinical data to the FDA for DCCR, designed for treating Prader-Willi Syndrome (PWS). Following a meeting with the FDA, they confirmed that existing studies and external data may support an NDA. The company aims to submit this data in the second half of 2021. PWS affects 1 in 15,000 live births, characterized by insatiable hunger among other symptoms. Currently, there are no approved treatments for PWS, and DCCR has Orphan Drug and Fast Track Designation.
Soleno Therapeutics (NASDAQ: SLNO) reported its third quarter and nine-month financial results on November 10, 2020. Key highlights included updated results from the Phase III DESTINY study of DCCR for Prader Willi Syndrome, demonstrating significant reductions in hyperphagia and improvements in body composition. R&D expenses rose to $4.8 million, and general and administrative expenses increased to $2.3 million. The company posted a net loss of $8.5 million for the quarter, compared to a prior net income of $0.9 million. Cash reserves improved to approximately $56.1 million.
Soleno Therapeutics (NASDAQ: SLNO) announced body composition data from its Phase III trial, DESTINY PWS, for Diazoxide Choline Controlled Release (DCCR) tablets aimed at treating Prader-Willi Syndrome (PWS). Presented by Dr. Parisa Salehi at ObesityWeek 2020, findings showed a significant reduction in fat mass (p=0.0027) and leptin levels (p<0.0001) in DCCR-treated patients. The study involved 127 participants and demonstrated promising effects on hyperphagia and metabolic components of PWS. Soleno maintains focus on advancing DCCR for regulatory approval.
Soleno Therapeutics (NASDAQ: SLNO) announced that body composition data from its Phase III trial, DESTINY PWS, will be presented at ObesityWeek® 2020. The presentation focuses on DCCR tablets for treating Prader-Willi Syndrome (PWS) and is scheduled for November 3, 2020. PWS is a rare genetic disorder affecting one in 15,000 births, characterized by insatiable hunger and related health complications. DCCR has received Orphan Drug and Fast Track Designation in the U.S. for PWS. Currently, there are no approved treatments for this condition, making DCCR's development critical.
Soleno Therapeutics (NASDAQ: SLNO) announced its Q2 2020 results, reporting a net loss of approximately $7.4 million, or $0.16 per share, compared to a loss of $10.0 million, or $0.31 per share, in Q2 2019. The company highlighted top-line results from the Phase III DESTINY PWS study of DCCR for Prader Willi Syndrome, noting no statistical significance in primary endpoints but positive trends in severe hyperphagia subgroups. Soleno raised $53.7 million through a public offering and had cash reserves of $62.5 million by June 30, 2020, positioning for future growth.
Soleno Therapeutics (NASDAQ: SLNO) announced its addition to the Russell 3000® Index as of June 29, 2020. This inclusion reflects the company's market capitalization and enhances visibility and liquidity for its shares. The Russell 3000® Index encompasses the 4,000 largest U.S. stocks, and membership also implies automatic inclusion in the Russell 1000® or Russell 2000® Index.
The CEO, Anish Bhatnagar, expressed optimism about this development, citing that it will benefit the ongoing program for Diazoxide Choline Controlled Release tablets for Prader-Willi Syndrome.
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