Latest news with #VykatXR
Yahoo
30-03-2025
- Business
- Yahoo
Why Soleno Therapeutics Inc. (SLNO) Went Up Last Week?
We recently published a list of . In this article, we are going to take a look at where Soleno Therapeutics Inc. (NASDAQ:SLNO) stands against other stocks that outperformed broader market last week. Wall Street's main indices traded lower week-on-week as investor sentiment continued to be dragged by the ongoing trade tensions globally. The tech-heavy Nasdaq was down by 2.59 percent versus its level on March 21. Meanwhile, the S&P 500 declined by 1.5 percent and the Dow Jones dropped by 0.956 percent. Ten individual stocks, on the other hand, managed to stay stronger, three of which were particularly notable as funds flocking to gold assets spilled over into their stocks. In this article, we listed last week's 10 top performers and detailed the reasons behind their gains. To come up with the list, we considered only the stocks with a $2-billion market capitalization and $5 million trading volume. A clinical-stage biopharmaceutical company's boardroom, emphasizing the importance of decision-making for the lead candidate development of a once-daily oral tablet. Soleno Therapeutics soared by 46.6 percent week-on-week to end at $71.99 on Friday versus the $49.11 close on March 21, after securing the approval of the Food and Drug Administration (FDA) for its diazoxide cholin—to be called Vykat XR—which aims to treat extreme hunger in patients with Prader-Willi syndrome. The syndrome is a rare genetic disorder caused by abnormalities in chromosome 15. Its symptoms include extreme hunger, low muscle tone, developmental delays, and behavioral challenges. Meanwhile, extreme hunger poses a threat to people with the syndrome and can lead to severe obesity and associated health complications. FDA's approval followed a three-month delay after the agency classified responses from Soleno as a 'major amendment' to its new drug application, requiring additional time to review. Overall, SLNO ranks 1st on our list of stocks that outperformed broader market last week. While we acknowledge the potential of SLNO as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. If you are looking for an AI stock that is as promising as SLNO but trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
29-03-2025
- Business
- Yahoo
Why Soleno Therapeutics Inc. (SLNO) Surged On Thursday?
We recently published a list of . In this article, we are going to take a look at where Soleno Therapeutics Inc. (NASDAQ:SLNO) stands against other stocks that jumped, defying market uncertainties on Thursday. The stock market extended losses on Thursday, with all the major indices ending in the red as investors continued to sell off positions to minimize risks from the ongoing trade tensions globally. The tech-heavy Nasdaq fell the hardest, down 0.53 percent, followed by the Dow Jones at 0.37 percent, and the S&P 500 at 0.33 percent. The broader market decline was mainly weighed down by shares in automakers following President Donald Trump's announcement of a 25-percent tariff on all vehicles imported to the US. Meanwhile, 10 companies defied a broader market pessimism amid fresh company developments that buoyed buying appetite. Two gold miners were particularly notable as investors sought safer assets amid the economic uncertainties. In this article, we listed Thursday's 10 best performers and detailed the reasons behind their gains. To come up with the list, we considered only the stocks with a $2-billion market capitalization and $5 million in trading volume. A clinical-stage biopharmaceutical company's boardroom, emphasizing the importance of decision-making for the lead candidate development of a once-daily oral tablet. Soleno Therapeutics jumped by 37.61 percent on Thursday to end at $67.39 apiece as investors cheered news that it secured the approval of the Food and Drug Administration (FDA) for its diazoxide cholin—to be called Vykat XR—which aims to treat extreme hunger in patients with Prader-Willi syndrome. The syndrome is a rare genetic disorder caused by abnormalities in chromosome 15. Its symptoms include low muscle tone, developmental delays, and behavioral challenges. Meanwhile, extreme hunger poses a threat to people with the syndrome and can lead to severe obesity and associated health complications. FDA's approval followed a three-month delay after the agency classified responses from Soleno as a 'major amendment' to its new drug application, requiring additional time to review. Overall, SLNO ranks 2nd on our list of stocks that jumped, defying market uncertainties on Thursday. While we acknowledge the potential of SLNO as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. If you are looking for an AI stock that is as promising as SLNO but trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
29-03-2025
- Business
- Yahoo
Why Soleno Therapeutics Inc. (SLNO) Went Up On Friday?
We recently published a list of . In this article, we are going to take a look at where Soleno Therapeutics Inc. (NASDAQ:SLNO) stands against other firms that end Friday strong. Wall Street's main indices finished the trading week in the negative territory as investor sentiment was weighed down by economic uncertainties brought about by the ongoing trade tensions globally. The tech-heavy Nasdaq fell the heaviest, by 2.70 percent, followed by the S&P 500, by 1.97 percent, and the Dow Jones, by 1.69 percent. Despite the broader market downturn, 10 individual stocks showed a strong performance during the trading session, with three companies particularly notable for hitting new all-time highs. In this article, we listed Friday's top performers and detailed the reasons behind their gains. To come up with the list, we considered only the stocks with a $2-billion market capitalization and $5 million in trading volume. A clinical-stage biopharmaceutical company's boardroom, emphasizing the importance of decision-making for the lead candidate development of a once-daily oral tablet. Soleno Therapeutics jumped for a second day on Friday, adding another 6.83 percent to its valuation to end at $71.99 apiece after securing the approval of the Food and Drug Administration (FDA) for its diazoxide cholin—to be called Vykat XR—which aims to treat extreme hunger in patients with Prader-Willi syndrome. The syndrome is a rare genetic disorder caused by abnormalities in chromosome 15. Its symptoms include extreme hunger, low muscle tone, developmental delays, and behavioral challenges. Meanwhile, extreme hunger poses a threat to people with the syndrome and can lead to severe obesity and associated health complications. FDA's approval followed a three-month delay after the agency classified responses from Soleno as a 'major amendment' to its new drug application, requiring additional time to review. Overall, SLNO ranks 3rd on our list of firms that end Friday strong. While we acknowledge the potential of SLNO as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and doing so within a shorter time frame. If you are looking for an AI stock that is as promising as SLNO but trades at less than 5 times its earnings, check out our report about the cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey.
Yahoo
27-03-2025
- Health
- Yahoo
Soleno wins FDA approval for Prader-Willi hyperphagia treatment
Soleno Therapeutics has won US Food and Drug Administration (FDA) approval for diazoxide choline – which will be branded as Vykat XR – to treat extreme hunger in patients with Prader-Willi syndrome. This approval follows a three-month delay from the FDA. In November 2024, the agency classified responses from Soleno as a 'major amendment' to its new drug application (NDA), requiring additional time to review. However, the agency did not raise concerns about the drug's safety, efficacy, or manufacturing. Prader-Willi syndrome is a rare genetic disorder caused by abnormalities in chromosome 15. Symptoms include low muscle tone, developmental delays, and behavioural challenges. Extreme hunger – known as hyperphagia, is one of the most serious and defining characteristics of the disorder and can lead to severe obesity and associated health complications if unmanaged. Vykat XR is now the only FDA-approved treatment specifically addressing hyperphagia in Prader-Willi syndrome. The FDA approval of Vykat XR was based on data from the Phase III Study C602-RWP clinical trial (NCT03714373). Efficacy was demonstrated during a 16-week randomised withdrawal study period. Patients who switched to a placebo demonstrated a statistically significant worsening of hyperphagia compared to those who remained on Vykat XR. The drug was also studied in the Phase III DESTINY-PWS trial (NCT03440814), which enrolled 127 individuals with genetically confirmed Prader-Willi syndrome. The trial did not demonstrate a statistically significant difference in hyperphagia reduction overall, but Soleno reported 'nominally significant' reductions in fat mass, and general improvements in condition as assessed by investigators. Vykat XR is set to launch in the US in April 2025, according to Soleno's 26 March announcement. Vykat XR – an extended-release tablet containing a crystalline salt formulation of diazoxide – works by activating the adenosine triphosphate (ATP)-sensitive potassium (KATP) channel, which plays a role in hunger regulation. The approval was welcomed by the Prader-Willi Syndrome Association: 'Today marks a historic day for the PWS community. The FDA's approval of Vykat XR represents a monumental step forward in addressing the longstanding unmet needs of individuals living with PWS and their families,' said Stacy Ward, CEO of the Association. Soleno also has its eyes set on Europe, having announced previously that it plans to file for approval of Vykat XR in the EU in the first half of 2025. According to GlobalData's Pharma Intelligence Center, Vykat XR is set to generate $876m in sales by 2030. GlobalData is the parent company of Pharmaceutical Technology. "Soleno wins FDA approval for Prader-Willi hyperphagia treatment" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
Yahoo
26-03-2025
- Health
- Yahoo
US FDA approves first treatment for rare genetic disorder Prader-Willi syndrome
By Sneha S K (Reuters) -The U.S. Food and Drug Administration on Wednesday approved Soleno Therapeutics' drug to treat a rare genetic disorder, making it the first treatment available for patients who experience feelings of intense and persistent hunger. The drug, to be called Vykat XR, treats hyperphagia, the hallmark symptom of the Prader-Willi syndrome, a genetic disorder caused by full or partial deletions on chromosome 15 that affect the regulation of gene expression, or how genes turn on and off. The debilitating condition, which affects about 50,000 people in the U.S., impacts everyday aspects of life, such as eating, behavior and mood. Starting in April 2025, Soleno plans to make the drug available in the U.S. for patients aged four years and older who have PWS with hyperphagia. The drug will have an annual average cost of $466,200 and will be dosed as per patients' weight, the company said. The syndrome's symptoms appear immediately, with infants born with low muscle tone and an inability to breastfeed. As patients grow older, children develop hyperphagia, a feeling of insatiable hunger persisting even after meals. This could occur as early as age four but, on average, starts at about age eight and then continues into adulthood. The increased appetite can lead to rapid weight gain and, if not controlled, obesity and related problems such as respiratory difficulties and heart disease. The company estimates the average lifespan of people with the disease is between 21 and 29 years. The drug is a once-daily oral pill designed to target a specific pathway in the brain to help reduce hyperphagia by decreasing the secretion of a peptide that is known to regulate appetite. LONG-AWAITED APPROVAL The long-awaited approval comes after the FDA's extended review of the drug and mixed results from a late-stage trial on its efficacy. The approval was based on data from the study and a randomized withdrawal study. In the late-stage trial involving 127 patients, the drug helped reduce feelings of intense hunger in the group of patients who had severe hyperphagia. The drug, however, did not show a statistically significant change in hyperphagia compared to the placebo group in the study. A long-term follow-up study in patients who had completed the late-stage trial showed the drug significantly reduced hyperphagia after at least one year of treatment. Justice Faith, a 21-year-old from Minneapolis, Minnesota, with PWS, said she is "very excited" that a treatment option may be available soon for hyperphagia. "My experience with hyperphagia, like everyone with PWS, is different from others," she said in an emailed statement ahead of the approval. An increased interest and awareness about food, as well as a generalized increase in anxiety, develop in people with PWS around childhood. Hyperphagia can also lead to a range of disruptive food-related behaviors, including aggressive food seeking. "There are a lot of questions about food, 'When are we going to have lunch? Are you sure it's time for lunch?' It's just non-stop," said Jennifer Miller, professor of pediatric endocrinology at the University of Florida. She was also a principal investigator on the trials for Vykat XR. "One of the patients, when I first started doing this 26 years ago, said to me, 'Imagine the hungriest you've ever been. That's how I feel all the time. I never ever feel like I've eaten.' That's why I started (treating patients), because of that comment," Miller said. Anthony Holland, president of the International Prader-Willi Syndrome Organisation said the IPWSO will work closely with the company as well as other global health bodies to expand access to the drug worldwide. "One of the tasks of our organization will be to campaign for its use more widely," Holland said.
