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.
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Soleno Therapeutics, Inc. (NASDAQ: SLNO) announced that CEO Anish Bhatnagar will participate in a fireside chat at the Guggenheim Healthcare Talks on April 3, 2023, at 10:10 AM Eastern Time. This event focuses on genomic medicines and rare diseases. Investors can access a live audio webcast as well as a replay of the discussion on the company's website. Soleno is actively developing innovative therapies for rare diseases, particularly its lead candidate, DCCR extended-release tablets, targeting Prader-Willi syndrome, which is in Phase 3 clinical trials.
Soleno Therapeutics (NASDAQ: SLNO) provided a corporate update and financial results for Q4 and full-year 2022. Enrollment in Study C602 for DCCR treatment of Prader-Willi syndrome is nearing completion, with top-line data expected by Q3 2023. The company secured a $60 million Securities Purchase Agreement with healthcare investors, with the first $10 million contingent upon the completion of enrollment. As of December 31, 2022, Soleno reported $14.6 million in cash. R&D expenses decreased to $15.3 million for the year, while net loss reduced to $24.1 million, or $2.87 per share. Strengthened funding enhances operational capability ahead of critical data announcements.
Soleno Therapeutics, Inc. (NASDAQ: SLNO), a clinical-stage biopharmaceutical company, has announced that CEO Anish Bhatnagar will participate in a fireside chat at Oppenheimer’s 33rd Annual Healthcare Conference on March 14, 2023, at 11:20 AM Eastern Time. This participation highlights Soleno's commitment to transparency and engagement with investors. The event will be accessible via a live audio webcast, available on the company’s website. Soleno specializes in developing novel therapeutics for rare diseases, with its lead candidate, DCCR, currently undergoing Phase 3 clinical trials for Prader-Willi syndrome.
Soleno Therapeutics (NASDAQ: SLNO) announced the publication of results from its Phase 3 DESTINY PWS trial for DCCR (Diazoxide Choline) Extended-Release tablets in treating Prader-Willi Syndrome (PWS) in the peer-reviewed Journal of Clinical Endocrinology and Metabolism. The promising trial outcomes have prompted the initiation of a randomized withdrawal phase in the ongoing extension study C602, potentially paving the way for a New Drug Application submission. PWS affects 1 in 15,000 births, marked by severe hunger and related health issues, underscoring the urgent need for effective treatments.
Soleno Therapeutics (SLNO) announced a funding agreement with Nantahala Capital, Abingworth, and Vivo Capital, securing up to $60 million. The agreement includes $10 million upfront and additional funds upon achieving positive clinical data for DCCR, its treatment for Prader-Willi Syndrome (PWS). DCCR is in a Phase 3 study targeting hyperphagia, a major symptom of PWS. The funding is set to enhance Soleno’s financial standing and support its New Drug Application submission.
Soleno Therapeutics, Inc. (NASDAQ: SLNO) reported its third quarter 2022 corporate update and financial results. The company initiated a randomized withdrawal period for Study C602, assessing DCCR for Prader-Willi syndrome (PWS), with top-line data expected in the first half of 2023. Financially, cash at quarter-end stood at $19.8 million. Research and development expenses were $3.8 million, down from $5.0 million in 2021. Net loss narrowed to $6.1 million, or $0.76 per share, compared to $8.1 million in the prior year.
Soleno Therapeutics (NASDAQ: SLNO) announced the initiation of a randomized withdrawal period for Study C602, focusing on DCCR (Diazoxide Choline) Extended-Release tablets, aimed at treating Prader-Willi syndrome (PWS). This pivotal phase of the study involves 80 patients across 22 sites, evaluating the drug's efficacy against a placebo. Positive discussions with the FDA suggest that data could support a New Drug Application. DCCR, designed to relieve symptoms of PWS, has received both Orphan Drug and Fast Track designations.
Soleno Therapeutics (NASDAQ: SLNO) announced that CEO Anish Bhatnagar will present a corporate overview at the H.C. Wainwright 24th Global Investment Conference from September 12-14, 2022. The conference will take place virtually and at Lotte New York Palace Hotel. The presentation will be available on-demand starting September 12 at 7:00 a.m. ET. Soleno focuses on developing innovative therapies for rare diseases, with its lead candidate, DCCR, currently in Phase 3 trials for Prader-Willi syndrome.
Soleno Therapeutics (NASDAQ: SLNO) reported second quarter 2022 financial results with a focus on DCCR, its lead product for treating Prader-Willi Syndrome (PWS). The FDA acknowledged that a randomized withdrawal phase of Study C602 could address efficacy concerns for an NDA submission. Cash reserves at June 30, 2022, were $24.1 million, sufficient to fund operations through early 2023. R&D expenses decreased from $5.6 million to $3.7 million year-over-year. The net loss narrowed to $6.7 million, down from $11 million in the same quarter of 2021.