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, 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.
Soleno Therapeutics, Inc. (NASDAQ: SLNO) has priced a public offering of 40 million shares at $0.25 each, with 20 million pre-funded warrants at $0.24, totaling gross proceeds of approximately $14.8 million. The offering includes accompanying warrants exercisable at $0.30 per share. Proceeds will fund research on DCCR tablets for Prader-Willi Syndrome and cover general corporate purposes. The offering is set to close around March 31, 2022, subject to customary conditions. Oppenheimer & Co. Inc. is the sole book-running manager.
Soleno Therapeutics, Inc. (NASDAQ: SLNO) announced its intention to offer and sell shares of common stock and pre-funded warrants in an underwritten public offering. Each share or pre-funded warrant will be sold with an exercisable common warrant. The offering's completion and terms are subject to market conditions. Proceeds will primarily fund research and development of the DCCR tablets for Prader-Willi Syndrome, along with general corporate purposes. Oppenheimer & Co. Inc. is the sole book-running manager for this offering.
Soleno Therapeutics (NASDAQ: SLNO) announced that Running for Research - Prader-Willi Syndrome will fund a clinical study of Diazoxide Choline Extended-Release (DCCR) for early-phase Prader-Willi Syndrome (PWS) patients. The multi-center trial will involve 40 subjects at four U.S. institutions, aiming to assess DCCR's effectiveness in preventing hyperphagia progression. Initial data from ongoing Phase 3 trials indicate potential benefits of DCCR. Running for Research exceeded their funding goals significantly, reflecting strong community support for the study.
Soleno Therapeutics, Inc. (NASDAQ: SLNO), a clinical-stage biopharmaceutical company, announced its CEO Anish Bhatnagar will present a corporate overview at the BIO CEO & Investor Conference on February 15, 2022, at 2:15 PM Eastern Time. The company focuses on developing novel therapeutics for rare diseases. Its lead candidate, DCCR extended-release tablets, is in Phase 3 clinical development for treating Prader-Willi Syndrome (PWS). For more information, visit www.soleno.life.
Soleno Therapeutics (NASDAQ: SLNO) announced the grant of inducement awards to new executives, Scott Madsen and Charles Horn, each receiving non-qualified stock options for 70,000 shares. The options have an exercise price of $0.34 per share, equal to the stock's closing price on January 28, 2022. The options will vest over four years, with 25% vesting each year upon continued employment. Soleno is focused on developing therapeutics for rare diseases, with its lead product, DCCR, in Phase 3 clinical trials for Prader-Willi Syndrome.
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