Soleno Therapeutics Inc Stock Price, News & Analysis

Soleno Therapeutics (NASDAQ: SLNO) announced that CEO Anish Bhatnagar will participate in a fireside chat at the 31st Annual Oppenheimer Healthcare Conference on March 16, 2021, at 1:50 PM ET. The live audio webcast and replay will be available on the company's website.

Soleno focuses on novel therapeutics for rare diseases, with its lead candidate, DCCR extended-release tablets, under Phase 3 development for Prader-Willi Syndrome. For further details, visit www.soleno.life.

Soleno Therapeutics, Inc. (NASDAQ: SLNO) announced an update regarding its DCCR (diazoxide choline) extended-release tablets for Prader-Willi Syndrome (PWS). Following a recent FDA interaction, Soleno submitted additional analyses from its Phase 3 DESTINY PWS trial, which indicated statistically significant improvements. However, the FDA has mandated an additional controlled clinical trial before proceeding with a New Drug Application (NDA). Soleno remains committed to expediting DCCR’s approval process, recognizing DCCR's potential in treating PWS, a rare disease affecting one in 15,000 live births in the U.S.

Soleno Therapeutics (NASDAQ: SLNO) released its Q4 and FY 2020 financial results, highlighting progress in its Phase 3 DESTINY PWS study for the treatment of Prader Willi Syndrome (PWS) with DCCR tablets. The study showed significant improvements in hyperphagia and other key metrics pre-COVID-19. Financially, Q4 net loss narrowed to $2.8 million from $14.6 million YoY. R&D expenses rose to $5.6 million, and total cash stood at $49.2 million by year-end. The company is also collaborating with Vanderbilt University to explore new treatment options.

Soleno Therapeutics (NASDAQ: SLNO) announced a collaboration with Vanderbilt University to develop novel K_ATP channel activators aimed at treating rare diseases. The collaboration will be led by Dr. Craig Lindsley and Dr. Jerod Denton, who will leverage their expertise to develop potential new therapeutics. Soleno's lead candidate, DCCR, has shown promise in Phase 3 trials for Prader-Willi syndrome. The partnership aims to create robust tools for identifying these activators, with expectations to advance successful candidates into clinical trials.

Soleno Therapeutics (NASDAQ: SLNO) hosted a webinar on February 5, 2021, to discuss the progress of its Phase 3 clinical trial for Diazoxide Choline Controlled Release (DCCR) tablets aimed at treating Prader-Willi Syndrome (PWS). The analysis showed statistically significant improvements in the primary and key secondary endpoints before the COVID-19 pandemic. DCCR treatment resulted in a notable decrease in hyperphagia, improving patient lives. The company continues to engage with regulatory authorities as it advances its PWS program.

Soleno Therapeutics, Inc. (NASDAQ: SLNO) will hold a KOL webinar on February 4, 2021, at 12:00 PM ET. The webinar features Dr. Jennifer Miller from the University of Florida discussing treatments for Prader-Willi Syndrome (PWS) and Soleno's Phase III DCCR program, alongside Dr. Theresa Strong from the Foundation for Prader-Willi Research addressing the pandemic's effects on PWS families. This event aims to update stakeholders on ongoing clinical trials and research developments.

Soleno Therapeutics (NASDAQ: SLNO), a clinical-stage biopharmaceutical company, announced a corporate overview presentation at the H.C. Wainwright Virtual BioConnect 2021 Conference from January 11-14, 2021. The presentation will be available on-demand starting January 11, 2021, on the company’s website, www.soleno.life. Soleno is focused on developing novel therapeutics for rare diseases, with its lead candidate, DCCR, targeting Prader-Willi Syndrome.

Soleno Therapeutics plans to submit analyses of clinical data to the FDA for DCCR, designed for treating Prader-Willi Syndrome (PWS). Following a meeting with the FDA, they confirmed that existing studies and external data may support an NDA. The company aims to submit this data in the second half of 2021. PWS affects 1 in 15,000 live births, characterized by insatiable hunger among other symptoms. Currently, there are no approved treatments for PWS, and DCCR has Orphan Drug and Fast Track Designation.

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.