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.
News about Soleno Therapeutics, Inc. (NASDAQ: SLNO) centers on its work as a biopharmaceutical company developing and commercializing novel therapeutics for rare diseases, with a primary focus on Prader-Willi syndrome (PWS) and hyperphagia. Company press releases highlight clinical, regulatory, commercial, and corporate developments related to its first commercial product, VYKAT XR (diazoxide choline) extended-release tablets.
Readers following SLNO news can find updates on VYKAT XR, a once-daily oral treatment indicated for hyperphagia in adults and pediatric patients 4 years of age and older with PWS. News items include details of the Phase 3 clinical program, such as the randomized withdrawal study published in the Journal of Clinical Endocrinology and Metabolism, which Soleno reports supported FDA approval as the first treatment for hyperphagia in people living with PWS.
Soleno’s news flow also covers financial results and launch metrics for VYKAT XR, including product revenue from U.S. sales, patient start forms, prescriber adoption, coverage levels, and commentary on achieving profitability and positive cash flow. Investors can track announcements about preliminary and full-quarter results, conference call schedules, and corporate presentations.
Additional news topics include capital allocation and corporate actions, such as the Board-authorized $100 million accelerated share repurchase agreement, amendments to loan facilities, and Board and Audit Committee changes. The company also issues communications on safety and regulatory matters, including an 8-K describing a serious adverse event reported in the FDA’s FAERS database and Soleno’s assessment of that case.
For those monitoring SLNO, this news stream provides insight into Soleno’s rare disease strategy, the commercial trajectory of VYKAT XR in PWS, and key corporate and regulatory milestones disclosed through press releases and SEC-referenced communications.
Soleno Therapeutics (NASDAQ: SLNO) announced body composition data from its Phase III trial, DESTINY PWS, for Diazoxide Choline Controlled Release (DCCR) tablets aimed at treating Prader-Willi Syndrome (PWS). Presented by Dr. Parisa Salehi at ObesityWeek 2020, findings showed a significant reduction in fat mass (p=0.0027) and leptin levels (p0.0001) in DCCR-treated patients. The study involved 127 participants and demonstrated promising effects on hyperphagia and metabolic components of PWS. Soleno maintains focus on advancing DCCR for regulatory approval.
Soleno Therapeutics (NASDAQ: SLNO) announced that body composition data from its Phase III trial, DESTINY PWS, will be presented at ObesityWeek® 2020. The presentation focuses on DCCR tablets for treating Prader-Willi Syndrome (PWS) and is scheduled for November 3, 2020. PWS is a rare genetic disorder affecting one in 15,000 births, characterized by insatiable hunger and related health complications. DCCR has received Orphan Drug and Fast Track Designation in the U.S. for PWS. Currently, there are no approved treatments for this condition, making DCCR's development critical.
Soleno Therapeutics (NASDAQ: SLNO) announced its Q2 2020 results, reporting a net loss of approximately $7.4 million, or $0.16 per share, compared to a loss of $10.0 million, or $0.31 per share, in Q2 2019. The company highlighted top-line results from the Phase III DESTINY PWS study of DCCR for Prader Willi Syndrome, noting no statistical significance in primary endpoints but positive trends in severe hyperphagia subgroups. Soleno raised $53.7 million through a public offering and had cash reserves of $62.5 million by June 30, 2020, positioning for future growth.
Soleno Therapeutics (NASDAQ: SLNO) announced its addition to the Russell 3000® Index as of June 29, 2020. This inclusion reflects the company's market capitalization and enhances visibility and liquidity for its shares. The Russell 3000® Index encompasses the 4,000 largest U.S. stocks, and membership also implies automatic inclusion in the Russell 1000® or Russell 2000® Index.
The CEO, Anish Bhatnagar, expressed optimism about this development, citing that it will benefit the ongoing program for Diazoxide Choline Controlled Release tablets for Prader-Willi Syndrome.
Soleno Therapeutics (Nasdaq: SLNO) has successfully closed its public offering of 34,848,484 shares at $1.65 per share, raising approximately $53.7 million net proceeds. The offering included 4,545,454 shares from the underwriters’ option. Guggenheim Securities served as the sole book-running manager, with Oppenheimer & Co. and Laidlaw & Company as managers. This offering was conducted under a shelf registration statement filed with the SEC. The funds will support Soleno's development of therapeutics, especially its lead candidate for Prader-Willi Syndrome, currently in Phase III trials.
Soleno Therapeutics, Inc. (Nasdaq: SLNO) has announced a public offering of 30,303,030 shares at $1.65 each, aiming to raise approximately $50 million. The underwriters have an option to purchase an additional 4,545,454 shares. Proceeds will primarily support the late-stage clinical development of DCCR tablets for Prader-Willi Syndrome. The offering is based on a shelf registration statement declared effective by the SEC. Guggenheim Securities is the lead manager for the offering, expected to close around June 26, 2020.
Soleno Therapeutics, Inc. (Nasdaq: SLNO) announced plans for an underwritten public offering of its common stock, with the potential for underwriters to purchase an additional 15% of the shares. The offering is contingent on market conditions and details regarding size and terms are not yet confirmed. Guggenheim Securities, LLC will act as the sole book-running manager for the offering. The securities are being registered with the SEC, and the company is focused on developing treatments for rare diseases, including its lead candidate for Prader-Willi Syndrome.
Soleno Therapeutics (SLNO) announced results from its Phase III trial, DESTINY PWS (C601), evaluating DCCR for treating Prader-Willi Syndrome (PWS). The study did not meet its primary endpoint for hyperphagia but showed significant improvements in a subgroup with severe hyperphagia, achieving a mean change of -9.67 (p=0.0124). Additionally, improvements were noted in two of three key secondary endpoints, including reduced body fat mass. An ongoing extension study (C602) revealed a 48% reduction in hyperphagia after six months of DCCR treatment. The safety profile of DCCR aligned with prior studies, with 83.3% of patients experiencing treatment-emergent adverse events.
Soleno Therapeutics (NASDAQ: SLNO) provided a corporate update and reported financial results for Q1 2020, highlighting the completion of enrollment in the Phase III DESTINY PWS study for DCCR in Prader Willi Syndrome. A total of 127 subjects were randomized across 29 sites. Despite a net loss of $5.9 million for Q1 2020, down from $7.0 million in Q1 2019, R&D expenses rose to $6.7 million due to increased activities for DCCR. As of March 31, cash and equivalents were approximately $15.1 million. Top-line data is expected by the end of the current quarter.