Soleno Therapeutics Inc Stock Price, News & Analysis

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.

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.