Latest news with #VYKAT™XR
Yahoo
21-05-2025
- Business
- Yahoo
Soleno Therapeutics to Participate in Upcoming June Conferences
REDWOOD CITY, Calif., May 21, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. ('Soleno') (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it will participate in the following investor conferences in June: Jefferies Global Healthcare ConferencePresentation Date: Wednesday, June 4, 2025 at 10:30 AM ETPresentation Format: Corporate PresentationWebcast: Here Goldman Sachs 46th Healthcare ConferencePresentation Date: Tuesday, June 10, 2025 at 8:40 AM ETPresentation Format: Corporate PresentationWebcast: Here A replay of both events will be available in the Investors section on the Company's website at About Soleno Therapeutics, Inc. Soleno is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The Company's first commercial product, VYKAT™ XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children four years of age and older with Prader-Willi syndrome. For more information, please visit Corporate Contact:Brian RitchieLifeSci Advisors, LLC212-915-2578
Yahoo
20-05-2025
- Health
- Yahoo
Soleno Therapeutics Announces Data Presentation Showing that Resumption of Treatment with VYKAT(TM) XR after a Randomized Withdrawal Period was Associated with Significant Improvements in Hyperphagia and Behavioral Symptoms in Participants with Prader-Willi Syndrome
REDWOOD CITY, Calif., May 20, 2025 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (NASDAQ: SLNO), a biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced data presented from its clinical development program of VYKAT™ XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, at the Pediatric Endocrine Society (PES) Annual Meeting 2025, which was held May 15-18 in National Harbor, Maryland, USA. The presentation showed that resumption of VYKAT XR treatment in participants with PWS following a 16-week randomized withdrawal was associated with significant improvements in both hyperphagia and behavioral symptoms. 'We are pleased to share the results from our ongoing clinical development program for VYKAT XR,' said Anish Bhatnagar, M.D., Chairman and Chief Executive Officer of Soleno Therapeutics. 'These results support the effectiveness of VYKAT XR in managing the critical symptoms of PWS and highlight the importance of long-term, continuous treatment.' Data Presented at the 2025 Pediatric Endocrine Society (PES) Annual Meeting Following long-term open label treatment with VYKAT XR for approximately 3 years (C602-OLE) and 16 weeks of randomized withdrawal (C602-RWP), participants who were randomized to placebo and restarted VYKAT XR in the open-label Study C614 showed improvements in hyperphagia by 13 weeks, with continued benefit through one year. Specifically, these participants showed a 6.3-point reduction in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) total score at one year —returning to levels similar to their pre-withdrawal baseline. Behavioral improvements were also demonstrated through one year, with improvements across all six domains assessed. About PWSThe Prader-Willi Syndrome Association USA estimates that PWS occurs in one in every 15,000 live births. The hallmark symptom of this disorder is hyperphagia, a chronic and life-threatening condition characterized by feelings of intense, persistent hunger, food pre-occupation, and an extreme drive to seek and consume food, which can severely diminish the quality of life for individuals with PWS and their families. Additional characteristics of PWS include behavioral problems, cognitive disabilities, low muscle tone, short stature (when not treated with growth hormone), the accumulation of excess body fat, developmental delays, and incomplete sexual development. Hyperphagia can lead to significant mortality (e.g., stomach rupture, choking, accidental death due to food seeking behavior) and longer term, co-morbidities such as diabetes, obesity, and cardiovascular disease. About VYKAT XR VYKAT XR was approved by the U.S. Food and Drug Administration (FDA) on March 26, 2025, and is now commercially available to U.S. patients. VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). IMPORTANT SAFETY INFORMATION ContraindicationsUse of VYKAT XR is contraindicated in patients who have a known hypersensitivity to diazoxide, other components of VYKAT XR, or to thiazides. Warnings and Precautions HyperglycemiaHyperglycemia, including diabetic ketoacidosis, has been reported. Before initiating VYKAT XR, test fasting plasma glucose (FPG) and HbA1c; optimize blood glucose in patients who have hyperglycemia. During treatment, regularly monitor fasting glucose (FPG or fasting blood glucose) and HbA1c. Monitor fasting glucose more frequently during the first few weeks of treatment in patients with risk factors for hyperglycemia. Risk of Fluid OverloadEdema, including severe reactions associated with fluid overload, has been reported. Monitor for signs or symptoms of edema or fluid overload. VYKAT XR has not been studied in patients with compromised cardiac reserve and should be used with caution in these patients. Adverse ReactionsThe most common adverse reactions (incidence ≥10% and at least 2% greater than placebo) included hypertrichosis, edema, hyperglycemia, and rash. Please see the full Prescribing Information, including Medication Guide. About Soleno Therapeutics, is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases. The company's first commercial product, VYKAT XR (diazoxide choline) extended-release tablets, formerly known as DCCR, is a once-daily oral treatment for hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome. For more information, please visit Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical facts contained in this press release are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as "may," "will," "should," "expect," "plan," "anticipate," "could," "intend," "target," "project," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these terms or other similar expressions. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, including those described in the company's prior press releases and in the periodic reports it files with the SEC. The events and circumstances reflected in the company's forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, the company does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Corporate Contact:Brian RitchieLifeSci Advisors, LLC212-915-2578 Media Contact:Soleno Therapeuticsmedia@ #2Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
07-05-2025
- Business
- Yahoo
Vivo Capital Closes Its Public Fund with Commitments of Over $740 Million
PALO ALTO, Calif., May 07, 2025--(BUSINESS WIRE)--Vivo Capital ("Vivo" or "the Firm"), a leading global investment firm focused exclusively on healthcare and life sciences, has closed the third cycle of its Vivo Opportunity Fund and its affiliates (the "Public Fund") with over $740 million in commitments. The Public Fund invests in preclinical and clinical stage life sciences businesses that are developing or commercializing novel therapies for unmet medical needs. Vivo Opportunity Fund is an evergreen fund with three-year investment cycles. The third cycle of Vivo Opportunity Fund will follow the same strategy as its first and second cycles, leveraging Vivo's deep scientific and technical capabilities to invest in small- and mid-cap biotechnology and life sciences companies. The aim of these investments is to capture value from breakthroughs and clinical milestones. The first two cycles of Vivo Opportunity Fund have successfully invested in companies that went on to announce significant milestones, such as regulatory approvals, or that were subsequently acquired by global pharmaceutical companies. Recent examples include Verona Pharmaceuticals and its Ohtuvayre™ treatment for chronic obstructive pulmonary disease (approved by the FDA in 2024), Geron Corporation's drug RYTELO™ for low-risk myelodysplastic syndrome (approved by the FDA in 2024), Avadel Pharmaceuticals and its Lumryz™ for narcolepsy (approved by the FDA in 2023) and, most recently, Soleno Therapeutics, which announced in March 2025 that its VYKAT™ XR treatment for Prader-Willi Syndrome has been approved for use by the FDA. This represents the first approved drug to treat the hallmark symptoms of this disease. Vivo-backed companies that were acquired by major pharmaceutical businesses include Sierra Oncology (acquired by GSK for $1.9 billion in 2022), Gracell Therapeutics (acquired by AstraZeneca for $1.2 billion in 2023), RayzeBio, Inc. (acquired by Bristol-Myers Squibb for $4.1 billion in 2024), Chinook Therapeutics (acquired by Novartis for $3.2 billion in 2023) and Kadmon (acquired by Sanofi for $1.9 billion in 2021). Kevin Dai, Managing Director at Vivo Capital, said: "As with its predecessors, the third cycle of the Vivo Opportunity Fund brings a venture capital mindset to the public markets, combining our long-term capital with our deep industry knowledge and experience to capture value for our investors. This strategy supports our approach of looking for the best opportunities across the entire healthcare spectrum."
Business Wire
07-05-2025
- Business
- Business Wire
Vivo Capital Closes Its Public Fund with Commitments of Over $740 Million
PALO ALTO, Calif.--(BUSINESS WIRE)--Vivo Capital ('Vivo' or 'the Firm'), a leading global investment firm focused exclusively on healthcare and life sciences, has closed the third cycle of its Vivo Opportunity Fund and its affiliates (the 'Public Fund') with over $740 million in commitments. The Public Fund invests in preclinical and clinical stage life sciences businesses that are developing or commercializing novel therapies for unmet medical needs. Vivo Opportunity Fund is an evergreen fund with three-year investment cycles. The third cycle of Vivo Opportunity Fund will follow the same strategy as its first and second cycles, leveraging Vivo's deep scientific and technical capabilities to invest in small- and mid-cap biotechnology and life sciences companies. The aim of these investments is to capture value from breakthroughs and clinical milestones. The first two cycles of Vivo Opportunity Fund have successfully invested in companies that went on to announce significant milestones, such as regulatory approvals, or that were subsequently acquired by global pharmaceutical companies. Recent examples include Verona Pharmaceuticals and its Ohtuvayre™ treatment for chronic obstructive pulmonary disease (approved by the FDA in 2024), Geron Corporation's drug RYTELO™ for low-risk myelodysplastic syndrome (approved by the FDA in 2024), Avadel Pharmaceuticals and its Lumryz™ for narcolepsy (approved by the FDA in 2023) and, most recently, Soleno Therapeutics, which announced in March 2025 that its VYKAT™ XR treatment for Prader-Willi Syndrome has been approved for use by the FDA. This represents the first approved drug to treat the hallmark symptoms of this disease. Vivo-backed companies that were acquired by major pharmaceutical businesses include Sierra Oncology (acquired by GSK for $1.9 billion in 2022), Gracell Therapeutics (acquired by AstraZeneca for $1.2 billion in 2023), RayzeBio, Inc. (acquired by Bristol-Myers Squibb for $4.1 billion in 2024), Chinook Therapeutics (acquired by Novartis for $3.2 billion in 2023) and Kadmon (acquired by Sanofi for $1.9 billion in 2021). Kevin Dai, Managing Director at Vivo Capital, said: 'As with its predecessors, the third cycle of the Vivo Opportunity Fund brings a venture capital mindset to the public markets, combining our long-term capital with our deep industry knowledge and experience to capture value for our investors. This strategy supports our approach of looking for the best opportunities across the entire healthcare spectrum.' Dr. Gaurav Aggarwal, Managing Partner at Vivo Capital, said: 'Vivo has been investing in healthcare and life sciences for almost 30 years, demonstrating consistency and supporting innovation across market cycles. We are extremely grateful to the entrepreneurs who enable the innovations we identify and for the support for Vivo Opportunity Fund that has been shown by our existing and new partners alike. We aim to repay this trust and confidence by consistently finding attractive opportunities across the public markets.' Since its founding in 1996, Vivo's mission has been to find and support the most promising healthcare companies globally to solve impactful healthcare issues. The Public Fund is part of the Firm's wide aperture approach to identifying healthcare opportunities across geographies, stages of development and sub-sectors, and complements the venture capital and growth equity/buyout strategies that comprise Vivo's multi-fund investment platform. About Vivo Capital Founded in 1996, Vivo Capital is a leading global healthcare investment firm with a diverse, multi-fund investment platform spanning venture capital, growth equity, buyout, and public equities. The Firm has approximately $5.3 billion in regulatory assets under management and has invested in over 430 public and private companies globally. Headquartered in Palo Alto, California, with additional offices in Asia, the Vivo team consists of more than 75 multi-disciplinary professionals. Vivo invests broadly in healthcare across multiple sub-sectors, including biotechnology, pharmaceuticals, medical devices, and healthcare services, with a focus on the largest healthcare markets globally.
