Soleno Therapeutics Inc Stock Price, News & Analysis

Soleno Therapeutics (NASDAQ: SLNO) reported second quarter 2022 financial results with a focus on DCCR, its lead product for treating Prader-Willi Syndrome (PWS). The FDA acknowledged that a randomized withdrawal phase of Study C602 could address efficacy concerns for an NDA submission. Cash reserves at June 30, 2022, were $24.1 million, sufficient to fund operations through early 2023. R&D expenses decreased from $5.6 million to $3.7 million year-over-year. The net loss narrowed to $6.7 million, down from $11 million in the same quarter of 2021.

Soleno Therapeutics (NASDAQ: SLNO) announced a significant update regarding its DCCR (diazoxide choline) extended-release tablets for Prader-Willi syndrome. After discussions with the FDA, the company confirmed that data from a proposed randomized withdrawal phase of Study C602 may satisfy the agency's concerns and support a New Drug Application (NDA) submission. This phase will commence shortly, with top-line data anticipated in Q1 2023. DCCR is currently the only candidate targeting hyperphagia associated with PWS, a condition affecting 1 in 15,000 U.S. births.

Soleno Therapeutics (NASDAQ: SLNO) presented key findings at the 11th International Prader-Willi Syndrome Organisation Conference in July 2022. The studies highlighted the long-term safety and efficacy of Diazoxide Choline Extended-Release (DCCR) tablets in patients with Prader-Willi Syndrome (PWS). Analysis of caregiver interviews revealed that over 65% reported positive changes in food-related behaviors, with 88% of participants experiencing improvements across various behavioral domains. DCCR has received Orphan Drug and Fast Track designations, supporting its potential as a therapeutic option for PWS.

Soleno Therapeutics announced positive clinical outcomes for its drug DCCR in treating Prader-Willi syndrome (PWS). Presented at ENDO 2022, findings revealed significant hormonal and cardiometabolic improvements after one year of treatment in 82 patients, including enhanced body composition, reduced leptin levels, and improved insulin sensitivity. Safety data highlighted common adverse events consistent with previous studies. DCCR shows potential as a meaningful therapy for PWS, addressing key symptoms while no approved treatments currently exist for the disorder.

Soleno Therapeutics, Inc. (NASDAQ: SLNO) announced participation in ENDO 2022, taking place June 11-14, 2022, in Atlanta, Georgia. The company will present two significant studies on Diazoxide Choline Extended-Release (DCCR) tablets for Prader-Willi Syndrome (PWS). The first is an oral presentation on hormonal and cardiometabolic changes on June 12, 2022, from 11 AM to 12:30 PM ET, presented by Dr. Eric Felner. The second, a poster session on long-term safety, will also occur on June 12, at 1 PM ET, presented by Dr. Michael Woloschak. Presentation materials will be available on the company's website.

Soleno Therapeutics (NASDAQ: SLNO) will present multiple studies at the 2022 European Congress of Endocrinology in Milan, Italy, from May 21-24. The presentations include updates on the long-term safety of Diazoxide Choline Extended-Release (DCCR) in treating Prader-Willi syndrome (PWS). Key presentations are scheduled for May 21 and May 22, with notable findings by Dr. Evelien Gevers and the DESTINY PWS Investigators. Further details and copies of the posters will be available on Soleno's website post-presentation.

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.