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Tag: Soleno Therapeutics

  • Soleno (SLNO) Stock Climbs In Pre-Hour Following Key FDA Decision

    Soleno (SLNO) Stock Climbs In Pre-Hour Following Key FDA Decision

    Following a major regulatory approval, Soleno Therapeutics, Inc. (NASDAQ: SLNO) stock has seen a sharp increase in value. SLNO shares were trading at $67.40 as of the recent pre-market check, representing a remarkable 37.64% rise. Following the U.S. Food and Drug Administration’s (FDA) approval of the company’s most recent medication for Prader-Willi syndrome (PWS), the stock has been rising.

    VYKAT XR is approved by the FDA

    Soleno Therapeutics’ VYKAT XR (diazoxide choline) extended-release tablets were officially approved by the FDA. Previously known as DCCR, this newly approved medication is designed to treat hyperphagia, an insatiable hunger disorder, in PWS children aged four and above. By April 2025, Soleno expects VYKAT XR to be commercially accessible in the US, providing a much-needed treatment alternative for individuals with the disease.

    A Revolution in the PWS Community

    For PWS patients and their families, the approval of VYKAT XR is a revolutionary development. The quality of life for both patients and caregivers has been greatly impacted by hyperphagia, which is thought to be the most incapacitating feature of the disease and has historically needed ongoing supervision and food restriction. The introduction of VYKAT XR provides new hope for managing this critical symptom, alleviating some of the burdens faced by families who have long struggled with the condition.

    Scientific Rigor and Safety Profile

    The FDA’s decision was supported by extensive clinical research and well-controlled studies demonstrating the efficacy and safety of VYKAT XR. Data from the clinical program indicated that patients who transitioned to a placebo experienced a statistically significant worsening of hyperphagia compared to those who continued with VYKAT XR. On average, participants had been on the medication for 3.3 years prior to the randomized withdrawal phase.

    VYKAT XR has demonstrated a well-established safety profile based on more than four years of safety data from several clinical investigations. Hypertrichosis, edema, hyperglycemia, and rash were the most often reported adverse effects, occurring in at least 10% of patients and at a rate 2% higher than placebo. These results support the medication’s ability to offer PWS patients significant comfort while keeping a tolerable safety level.

  • FDA Regulatory News Sends Soleno Therapeutics (SLNO) Shares Higher

    FDA Regulatory News Sends Soleno Therapeutics (SLNO) Shares Higher

    Following a substantial regulatory update, shares of Soleno Therapeutics, Inc. (NASDAQ: SLNO) are soaring on U.S. stock charts today. SLNO stock is trading 15.67% higher at $55.10 as of the last check during current session. Investor interest has been piqued by the company’s emphasis on treating Prader-Willi syndrome (PWS), which has improved stock performance.

    FDA Review on DCCR Therapy for PWS

    Soleno Therapeutics has received an update from the U.S. Food and Drug Administration (FDA) on rules pertaining to its New Drug Application (NDA) for extended-release DCCR (diazoxide choline) tablets. The FDA Review Division concluded that it might not be necessary to hold an advisory committee meeting at this time.

    However, as the review process moves further, the review team will continue to determine whether or not a meeting of this kind is truly required. With a December 27, 2024, Prescription Drug User Fee Act, or PDUFA target action date, DCCR has been awarded Priority Review status for its investigation as a possible therapy for PWS, a rare genetic condition.

    Effects of Prader-Willi syndrome on individuals

    According to the Prader-Willi Syndrome Association USA, the condition affects one in every fifteen live births. Hyperphagia, a potentially deadly disorder characterized by intense hunger and an obsession with eating, is the primary symptom of the sickness.

    In addition to behavioral issues, poor muscle tone, cognitive impairments, developmental delays, and co-morbidities including diabetes and cardiovascular disease, people with PWS also have various consequences. The discovery of DCCR is highly significant because there are currently no licensed medicines to address these incapacitating symptoms.

    DCCR’s Promise in Treating PWS

    DCCR is a novel, extended-release formulation of diazoxide choline, a compound previously used to treat various rare conditions, though not yet approved for PWS. Soleno (SLNO) has secured extensive patent protection for DCCR, which has demonstrated promising results in clinical trials.

    In the Phase 3 clinical development program, DCCR showed efficacy in reducing hyperphagia and improving other symptoms such as aggressive behaviors and fat mass, offering hope to individuals living with PWS.

  • Soleno Therapeutics (SLNO) Stock Gains Traction With Recent Regulatory Approvals

    Soleno Therapeutics (SLNO) Stock Gains Traction With Recent Regulatory Approvals

    Soleno Therapeutics, Inc. (NASDAQ: SLNO) stock is witnessing a remarkable surge of 19.95% in its shares, trading at $45.45 as of the last check during current market. This noteworthy upswing of SLNO stock on the US charts is directly attributable to regulatory greenlights.

    Today, Soleno Therapeutics (SLNO) announced that diazoxide choline has been designated as a breakthrough therapy by the U.S. Food and Drug Administration (FDA). This classification is for the therapeutic intervention of adults and children four years of age and older with hyperphagia and genetically proven Prader-Willi syndrome (PWS).

    The conferment of this designation underscores the Agency’s discernment that, based on an evaluation of preliminary data emanating from the Phase 3 clinical development program, diazoxide choline exhibits the potential for substantial enhancement on clinically significant endpoint(s) compared to existing therapies.

    This milestone, marked by the grant of Breakthrough Therapy Designation, signifies a significant advancement for Soleno Therapeutics’ DCCR clinical development initiative, notably as the first such designation for a drug aimed at PWS treatment.

    This pivotal designation serves as affirmation of the FDA’s recognition of PWS as a severe medical condition and indicates the promising prospects of DCCR as a safe and efficacious therapeutic intervention for PWS. SLNO remains steadfast in its commitment to preparing the NDA submission for DCCR in PWS, with an anticipated timeframe around mid-2024.

    The FDA’s Breakthrough Therapy Designation is tailored to accelerate the development and evaluation processes of drugs in the U.S. designated for the treatment of severe medical conditions, particularly when initial clinical data suggests significant improvements over existing therapies on clinically relevant parameters.

    By bestowing Breakthrough Therapy Designation, the FDA facilitates comprehensive guidance and institutional dedication involving senior management in a proactive, collaborative, interdisciplinary review process, potentially enabling priority review and other measures to expedite assessment.

    Diazoxide choline holds Orphan Drug Designation for PWS in both the U.S. and E.U., along with Fast Track Designation in the U.S.

  • Proposed Public Offering: Soleno Therapeutics Inc. (SLNO) stock Crumbles After Hours

    Proposed Public Offering: Soleno Therapeutics Inc. (SLNO) stock Crumbles After Hours

    On March 28, Soleno Therapeutics Inc. (SLNO) took a harsh hit and crumbled down in the after-hours session. This downfall comes from the company’s latest news regarding a proposed public offering of its common stock.

    SLNO stock was already trading in the red during the regular session but the public offering news escalated its fall in the after hours. At the close of the regular session, the stock had a value of $0.2876 per share with a loss of 3.68%. In intraday trading, the stock fluctuated between $0.2850 and $0.3100 at a volume of 945.9K shares. Following the announcement, the stock plunged deep in the after-hours to lose a huge 23.50%. Hence, SLNO stock was trading at a value of $0.2200 per share in the after hours. The volume of the session remained active with 679.74K shares exchanged.

    The rare diseases novel therapeutics developer, Soleno Therapeutics Inc. is focused on metabolic and neurobehavioral disorders. Founded in 1999, the company has a market capitalization of $23.83 million with its 79.81 million outstanding shares. Currently, SLNO stands on a year-to-date loss of 29.85% while it lost 76.81% last year.

    SLNO’s Public Offering

    On Monday, the company announced its intention of offering its common stock shares in an underwritten public offering. Moreover, the offering will also include pre-funded warrants for the purchase of SLNO common stock. One share of common stock or a pre-funded warrant will be sold together with a common warrant for buying a common share which will be immediately exercisable.

    The company plans to use the net proceeds from the offering for funding its ongoing R&D efforts focused on its lead candidate along with general corporate purposes. Furthermore, the book-running manager for the offering is Oppenheimer & Co. Inc.

    The terms, conditions, and size of the actual offering were not shared.

    Source: BIN.ua

    DCCR tablets Updates

    Diazoxide Choline Extended-Release tablets (DCCR) is the company’s lead product candidate for Prader-Willi Syndrome (PWS).

    On March 09, the company announced that Running for Research – Prader-Willi Syndrome (RFR) will fund an investigator-sponsored clinical study of DCCR in early phase PWS patients. The RFR is an organization that raises private donations for advancing the science around PWS.

    Expected to be a multi-center trial, the study will evaluate the effects of DCCR in pre-hyperphagic patients with PWS.

    SLNO’s Recent Participation

    On February 15, SLNO participated in BIO CEO & Investor Conference. The company’s Chief Executive Officer Anish Bhatnagar M.D. presented a corporate overview of the company at the conference.