Soleno Therapeutics Inc Stock Price, News & Analysis

Soleno Therapeutics (NASDAQ: SLNO) reported its third quarter and nine-month financial results on November 10, 2020. Key highlights included updated results from the Phase III DESTINY study of DCCR for Prader Willi Syndrome, demonstrating significant reductions in hyperphagia and improvements in body composition. R&D expenses rose to $4.8 million, and general and administrative expenses increased to $2.3 million. The company posted a net loss of $8.5 million for the quarter, compared to a prior net income of $0.9 million. Cash reserves improved to approximately $56.1 million.

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 (p<0.0001) 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.