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), a biopharmaceutical company, updated on its progress with the FDA regarding its DCCR (diazoxide choline) extended-release tablets for treating Prader-Willi syndrome (PWS). Following a Type C meeting on December 21, 2021, the FDA showed receptiveness to a study design utilizing current participants from the ongoing Study C602 to gather additional clinical data necessary for a New Drug Application (NDA). The company plans to submit a proposal for this study soon. Currently, there are no approved therapies addressing the symptoms of PWS, underscoring the significance of Soleno’s work.
Soleno Therapeutics, Inc. (NASDAQ: SLNO) announced the participation of CEO Anish Bhatnagar in a panel discussion at the LifeSci Partners 11th Annual Corporate Access Event on January 6, 2022. The panel, titled Patient Advocacy: Honing the Skill for Crossover Communications between Patients and Stakeholders, will take place at 2:00 PM ET. A live webcast is available at this link, and a replay can be accessed on the company’s website. Soleno is focused on developing treatments for rare diseases, notably evaluating its lead candidate for Prader-Willi Syndrome.
Soleno Therapeutics (NASDAQ: SLNO) announced the grant of stock options to new VP of Clinical Development, Michael Woloschak, in compliance with Nasdaq rules.
The non-qualified stock option is for 75,000 shares at an exercise price of $0.763, equal to Soleno's stock closing price on November 16, 2021. The options vest over four years, beginning with 1/4 on the one-year anniversary of September 27, 2021, and subsequently 1/48 each month, contingent on continued employment.
Soleno focuses on developing therapies for rare diseases, including its candidate for Prader-Willi Syndrome.
Soleno Therapeutics (SLNO) reported financial results for Q3 and nine months ended September 30, 2021. The company is developing DCCR, a treatment for Prader-Willi syndrome (PWS), with promising data from its open-label extension study, C602. Significant improvements were reported in hyperphagia and PWS-related behaviors after 52 weeks of treatment. Financially, R&D expenses were $5.0 million for Q3 compared to $4.8 million last year. The net loss for Q3 was $8.1 million, slightly down from $8.5 million in 2020. As of September 30, 2021, cash and equivalents totaled approximately $28.2 million.
Soleno Therapeutics, a clinical-stage biopharmaceutical company (NASDAQ: SLNO), announced that CEO Anish Bhatnagar will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on September 30, 2021, at 2:40 PM ET.
A live audio webcast and replay can be accessed on the company’s website. Soleno focuses on developing therapeutics for rare diseases, particularly DCCR extended-release tablets for treating Prader-Willi Syndrome, currently in a Phase 3 clinical program.
Soleno Therapeutics (NASDAQ: SLNO) will have its CEO, Anish Bhatnagar, present a corporate overview at the Oppenheimer Fall Healthcare Life Sciences and MedTech Summit on September 20, 2021, at 1:15 PM ET. A live audio webcast will be accessible via the company's website. Soleno is dedicated to developing therapeutics for rare diseases, with its lead candidate, DCCR extended-release tablets, currently in Phase 3 trials for Prader-Willi Syndrome.
Soleno Therapeutics (NASDAQ: SLNO) announced positive top-line results from its open-label extension study (C602), evaluating DCCR (Diazoxide Choline) for Prader-Willi syndrome (PWS). The study included 115 subjects and demonstrated significant improvements in hyperphagia and PWS-related behaviors over 52 weeks. Improvements in lean body mass and metabolic parameters were also observed. Soleno plans to submit data to the FDA for a New Drug Application in Q3 2021, although additional trials may be needed. The results provide hope for a potential new treatment for PWS.
Soleno Therapeutics (NASDAQ: SLNO) reported a net loss of $11 million for Q2 2021, widening from $7.4 million year-over-year. R&D costs fell slightly to $5.6 million, while general and administrative expenses increased to $2.5 million. The company is focused on advancing DCCR for Prader-Willi syndrome, continuing discussions with the FDA for potential NDA submission. Soleno holds $33.6 million in cash as of June 30, 2021, down from $49.2 million at year-end 2020. They also received patent allowances in various countries extending DCCR protection until at least 2035.
FDA Review on DCCR for Prader-Willi Syndrome
On July 2, 2021, Soleno Therapeutics announced that the FDA will review additional data related to its DCCR (diazoxide choline) extended-release tablets aimed at treating Prader-Willi Syndrome (PWS). The FDA indicated that an additional clinical trial is necessary but is open to assessing existing Phase 3 trial data, with a submission expected by Q3 2021. PWS affects 1 in 15,000 births and lacks approved therapies for its symptoms, notably hyperphagia. DCCR has received Orphan Drug and Fast Track designations.
Soleno Therapeutics (NASDAQ: SLNO) announced that the FDA has granted Orphan Drug Designation to its investigational drug DCCR for treating Glycogen Storage Disease Type 1a (GSD 1a). This designation is a significant milestone, as GSD 1a currently lacks approved therapies. DCCR, which also received Orphan Drug Designation for Prader-Willi syndrome, acts as an ATP-dependent potassium channel agonist, aiming to alleviate symptoms of hypoglycemia and reduce fat synthesis. Orphan Drug Designation offers various incentives, including market exclusivity and tax credits for clinical trials.
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