Soleno Therapeutics Inc - SLNO STOCK NEWS

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.

Soleno Therapeutics (NASDAQ: SLNO) will host a webinar on May 24, 2021, at the 23rd European Congress of Endocrinology, focusing on DCCR (diazoxide choline) Extended-Release tablets for treating Prader-Willi syndrome (PWS). Key opinion leaders from the UK and France will discuss results from the DESTINY PWS Phase 3 study. PWS affects 1 in 15,000 births, causing severe hyperphagia, which significantly impacts patients' quality of life. Currently, no approved therapies exist for PWS symptoms. DCCR has received Orphan Drug and Fast Track Designations in the U.S. and EU.

Soleno Therapeutics, Inc. (NASDAQ: SLNO) will present a corporate overview at the Oppenheimer Rare & Orphan Disease Summit on May 21, 2021, at 1:15 PM ET. CEO Anish Bhatnagar will lead the presentation, highlighting the company's focus on developing novel therapeutics for rare diseases, particularly its lead candidate, DCCR extended-release tablets, aimed at treating Prader-Willi Syndrome (PWS) in Phase 3 clinical trials. A live audio webcast will be available on the company’s website.

Soleno Therapeutics (NASDAQ: SLNO) reported Q1 2021 results, showing a net loss of $9.0 million ($0.11 per share), compared to a $5.9 million loss in Q1 2020. R&D expenses rose to $7.2 million from $6.7 million, driven by the DCCR program for Prader-Willi Syndrome (PWS). The company is engaging with the FDA on regulatory steps for DCCR and shared positive behavioral outcomes data from ongoing studies. Cash available was about $41.6 million as of March 31, 2021. Soleno aims to submit a marketing application for DCCR as it continues to develop treatments for rare diseases.

Soleno Therapeutics (NASDAQ: SLNO) announced positive behavioral outcomes from its ongoing open-label extension study of DCCR for Prader-Willi Syndrome (PWS) at the Pediatric Academic Societies Annual Meeting. The study analyzed 48 caregiver interviews, revealing 39 behavioral outcomes across seven domains. Notably, 83% reported positive behavior changes with DCCR. The data underlines DCCR's potential as a safe treatment for PWS, addressing significant behavioral issues linked to the disorder. The company aims to collaborate with the FDA on the path forward for DCCR.

Soleno Therapeutics (NASDAQ: SLNO) announced CEO Anish Bhatnagar's participation in a Prader-Willi Syndrome (PWS) DCCR Town Hall on April 14, 2021. The event highlighted the unmet medical needs of PWS patients and the company's commitment to obtaining regulatory approval for DCCR. Bhatnagar discussed insights from the Foundation for Prader-Willi Research regarding patient experiences in clinical trials. DCCR, a novel treatment for PWS, is currently in Phase 3 trials and has received Orphan Drug and Fast Track Designation in the U.S. and EU.