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Soleno Therapeutics

69.98

+0.05000.07%

Post-market: 66.00-3.9800-5.69%19:55 EDT

Volume:1.24M

Turnover:85.92M

Market Cap:3.21B

PE:-15.99

High:70.51

Open:69.96

Low:68.34

Close:69.93

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Overview Company News Filings

BUZZ-Soleno falls after FDA rejects peer Applied's genetic disease drug

Soleno Therapeutics to Participate in Piper Sandler 36th Annual Healthcare Conference

Soleno Tumbles 17% as FDA Extends Review Timeline for Prader-Willi Treatment

Soleno Therapeutics Shares Down 2.9% After Co Announces US FDA Extension of Review Period for Genetic Disorder Treatment

THOMSON REUTERS

BUZZ-Soleno Therapeutics falls as FDA extends review of genetic disorder drug

Soleno Therapeutics Says FDA Extends DCCR NDA Review Citing 'Major Amendment'

MT Newswires Live

BRIEF-Soleno Therapeutics Announces FDA Extension Of Review Period For DCCR

Soleno Therapeutics Shares Slide 13% Premarket After Co Announces US FDA Extension of Review Period for Genetic Disorder Treatment

THOMSON REUTERS

Soleno Therapeutics announces U.S.. FDA to ended review period for NDA

Soleno Therapeutics Inc - New Pdufa Target Action Date Set for March 27, 2025

THOMSON REUTERS

Soleno Therapeutics Announces FDA Extension of Review Period for Dccr (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome

THOMSON REUTERS

Soleno Therapeutics Inc - FDA Did Not Cite Safety, Efficacy or Manufacturing Concerns

THOMSON REUTERS

Soleno: FDA Determined That Responses to Recent Information Requests Constituted a Major Amendment to Nda for Dccr Extended-Release Tablets

THOMSON REUTERS

Soleno Therapeutics Announces FDA Extension of Review Period for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome

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Soleno Therapeutics Announces Oral Presentations Featuring Diazoxide Choline Extended-Release (Dccr) Tablets in Prader-Willi Syndrome at Espe 2024

THOMSON REUTERS

Soleno Therapeutics Announces Oral Presentations featuring Diazoxide Choline Extended-Release (DCCR) Tablets in Prader-Willi Syndrome at ESPE 2024

Here's Why We're Not At All Concerned With Soleno Therapeutics' (NASDAQ:SLNO) Cash Burn Situation

Simply Wall St.

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brokerage Baird** On Friday, FDA rejects APLT's drug to treat galactosemia, a rare genetic metabolic disease** Baird says SLNO's drug DCCR meets FDA's standard of substantial evidence of effectiveness at face value** In SLNO's study, in consultation with the FDA, DCCR met the main goal, whereas APLT's drug missed the main goal in its study - brokerage** SLNO has FDA's breakthrough designation for DCCR, while APLT does not - Baird** SLNO has a stronger application for approval and more external validation from the FDA - brokerage** FDA will decide on SLNO's drug by Mar. 27** YTD, SLNO up 28.8%  ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241129:nL3N3N013G:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU0320765992.SGD","APLT","LU0109394709.USD","SLNO","BK4139","LU0889565916.HKD"],"gpt_icon":0},{"id":"2486291248","title":"Soleno Therapeutics to Participate in Piper Sandler 36th Annual Healthcare Conference","url":"https://stock-news.laohu8.com/highlight/detail?id=2486291248","media":"GlobeNewswire","labels":["conferences"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486291248?lang=en_us&edition=fundamental","pubTime":"2024-11-27 21:00","pubTimestamp":1732712400,"startTime":"0","endTime":"0","summary":"REDWOOD CITY, Calif., Nov.  27, 2024  (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc.(“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.globenewswire.com/news-release/2024/11/27/2988164/0/en/Soleno-Therapeutics-to-Participate-in-Piper-Sandler-36th-Annual-Healthcare-Conference.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"conferences","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["SLNO","BK4137","PWS","BK4139","HCSG"],"gpt_icon":0},{"id":"2486002847","title":"Soleno Tumbles 17% as FDA Extends Review Timeline for Prader-Willi Treatment","url":"https://stock-news.laohu8.com/highlight/detail?id=2486002847","media":"GuruFocus.com","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486002847?lang=en_us&edition=fundamental","pubTime":"2024-11-26 23:08","pubTimestamp":1732633682,"startTime":"0","endTime":"0","summary":"Following the U.S. Food and Drug Administration extending the review period for the company's New Drug Application  for diazoxide choline extended-release tablets, Soleno Therapeutics  saw its shares fall 17% in premarket trade Tuesday.GuruFocus has detected 3 Warning Sign with SLNO.The treatment aims at hyperphagia in patients four years of age and above with Prader-Willi syndrome. The FDA's decision that responds to recent information requests significantly changed the NDA qualifies the review extension.The government has thus established a new Prescription Drug User Fee Act  action deadline of March 27, 2025, so shifting the schedule by three months. The FDA did not express worries about the safety, efficacy, or manufacture of the medicine in spite of the delay Originally turning in the NDA on June 27, 2024, Soleno had it approved in August under Priority Review status.This article first appeared on","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/i00gJ_aFxHHLjDZatWAysQ--~B/aD0zNjc7dz01NTA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/us.finance.gurufocus/107289ced6e8b2ded9f6d7c330bf5ada","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/i00gJ_aFxHHLjDZatWAysQ--~B/aD0zNjc7dz01NTA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/us.finance.gurufocus/107289ced6e8b2ded9f6d7c330bf5ada"],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/soleno-tumbles-17-fda-extends-150802132.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["SLNO","BK4139"],"gpt_icon":0},{"id":"2486009164","title":"Soleno Therapeutics Shares Down 2.9% After Co Announces US FDA Extension of Review Period for Genetic Disorder Treatment","url":"https://stock-news.laohu8.com/highlight/detail?id=2486009164","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486009164?lang=en_us&edition=fundamental","pubTime":"2024-11-26 22:35","pubTimestamp":1732631710,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241126:nL3N3MX19C:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["SLNO","BK4139"],"gpt_icon":0},{"id":"2486066930","title":"BUZZ-Soleno Therapeutics falls as FDA extends review of genetic disorder drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2486066930","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486066930?lang=en_us&edition=fundamental","pubTime":"2024-11-26 22:18","pubTimestamp":1732630681,"startTime":"0","endTime":"0","summary":"BUZZ-Soleno Therapeutics falls as FDA extends review of genetic disorder drug ** Shares of drug developer Soleno Therapeutics SLNO.O fall ~6% to $54 premarket  ** Co says U.S. FDA has extended review of its experimental drug to treat Prader–Willi syndrome, a rare genetic disorder** The condition causes affected individuals to develop extreme hunger, which leads to chronic overeating, or hyperphagia, and obesity  ** FDA determined that co's responses to recent information requests constituted major amendment to marketing application for the drug, diazoxide choline extended-release tablets ** The health regulator will now give its decision by March 27, 2025, compared with its previous action date of Dec. 27 this year** FDA did not cite any safety, efficacy or manufacturing concerns, SLNO says** Up to last close, stock up ~42% YTD  ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241126:nL3N3MX16V:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","SLNO"],"gpt_icon":0},{"id":"2486500511","title":"Soleno Therapeutics Says FDA Extends DCCR NDA Review Citing 'Major Amendment'","url":"https://stock-news.laohu8.com/highlight/detail?id=2486500511","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486500511?lang=en_us&edition=fundamental","pubTime":"2024-11-26 22:03","pubTimestamp":1732629831,"startTime":"0","endTime":"0","summary":"Soleno Therapeutics  said Tuesday the US Food and Drug Administration has extended its review period for the New Drug Application of DCCR by three months after determining that recent responses to the FDA's information requests represent a \"major amendment.\"The company said the FDA, which set a new target action date of March 27, did not raise concerns about the drug's safety, efficacy, or manufacturing.The NDA, submitted in June and accepted with priority review in August, seeks approval for diazoxide choline extended-release tablets, known as DCCR, for the treatment of hyperphagia in individuals aged four and older with Prader-Willi syndrome, Soleno said.Diazoxide choline has previously received Breakthrough and Fast Track designations in the US, and the Orphan Drug designation in the US and EU, the company added.Shares of the company were down more than 5% in recent Tuesday premarket activity.Price: 54.00, Change: -3.22, Percent Change: -5.63","market":"sg","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["SLNO","BK4139"],"gpt_icon":0},{"id":"2486700800","title":"BRIEF-Soleno Therapeutics Announces FDA Extension Of Review Period For DCCR","url":"https://stock-news.laohu8.com/highlight/detail?id=2486700800","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486700800?lang=en_us&edition=fundamental","pubTime":"2024-11-26 21:43","pubTimestamp":1732628588,"startTime":"0","endTime":"0","summary":"BRIEF-Soleno Therapeutics Announces FDA Extension Of Review Period For DCCRNov 26 (Reuters) - Soleno Therapeutics Inc SLNO.O:SOLENO THERAPEUTICS ANNOUNCES FDA EXTENSION OF REVIEW PERIOD FOR DCCR (DIAZ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241126:nTUAZGBWM:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["SLNO","BK4139"],"gpt_icon":0},{"id":"2486442008","title":"Soleno Therapeutics Shares Slide 13% Premarket After Co Announces US FDA Extension of Review Period for Genetic Disorder Treatment","url":"https://stock-news.laohu8.com/highlight/detail?id=2486442008","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486442008?lang=en_us&edition=fundamental","pubTime":"2024-11-26 21:38","pubTimestamp":1732628298,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241126:nFWN3MX081:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["SLNO","BK4139"],"gpt_icon":0},{"id":"2486008775","title":"Soleno Therapeutics announces U.S.. FDA to ended review period for NDA","url":"https://stock-news.laohu8.com/highlight/detail?id=2486008775","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486008775?lang=en_us&edition=fundamental","pubTime":"2024-11-26 21:35","pubTimestamp":1732628139,"startTime":"0","endTime":"0","summary":"Soleno Therapeutics (SLNO) announced that the U.S. Food and Drug Administration, FDA, has extended the review period for the New Drug Application, ...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/soleno-therapeutics-announces-u-s-fda-to-ended-review-period-for-nda?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/soleno-therapeutics-announces-u-s-fda-to-ended-review-period-for-nda?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["BK4139","SLNO"],"gpt_icon":0},{"id":"2486600839","title":"Soleno Therapeutics Inc - New Pdufa Target Action Date Set for March 27, 2025","url":"https://stock-news.laohu8.com/highlight/detail?id=2486600839","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486600839?lang=en_us&edition=fundamental","pubTime":"2024-11-26 21:30","pubTimestamp":1732627800,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241126:nTUAZGBWM:2","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["SLNO","BK4139"],"gpt_icon":0},{"id":"2486008831","title":"Soleno Therapeutics Announces FDA Extension of Review Period for Dccr (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome","url":"https://stock-news.laohu8.com/highlight/detail?id=2486008831","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486008831?lang=en_us&edition=fundamental","pubTime":"2024-11-26 21:30","pubTimestamp":1732627800,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241126:nTUAZGBWM:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["SLNO","BK4139"],"gpt_icon":0},{"id":"2486008399","title":"Soleno Therapeutics Inc - FDA Did Not Cite Safety, Efficacy or Manufacturing Concerns","url":"https://stock-news.laohu8.com/highlight/detail?id=2486008399","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486008399?lang=en_us&edition=fundamental","pubTime":"2024-11-26 21:30","pubTimestamp":1732627800,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241126:nTUAZGBWM:3","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","SLNO"],"gpt_icon":0},{"id":"2486008392","title":"Soleno:  FDA Determined That Responses to Recent Information Requests Constituted a Major Amendment to Nda for Dccr Extended-Release Tablets","url":"https://stock-news.laohu8.com/highlight/detail?id=2486008392","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486008392?lang=en_us&edition=fundamental","pubTime":"2024-11-26 21:30","pubTimestamp":1732627800,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241126:nTUAZGBWM:4","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","SLNO"],"gpt_icon":0},{"id":"2486084930","title":"Soleno Therapeutics Announces FDA Extension of Review Period for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome","url":"https://stock-news.laohu8.com/highlight/detail?id=2486084930","media":"GlobeNewswire","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2486084930?lang=en_us&edition=fundamental","pubTime":"2024-11-26 21:30","pubTimestamp":1732627800,"startTime":"0","endTime":"0","summary":"PDUFA target action date extended by three months to March 27, 2025REDWOOD CITY, Calif., Nov.  26, 2024  (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage bioph","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.globenewswire.com/news-release/2024/11/26/2987503/0/en/Soleno-Therapeutics-Announces-FDA-Extension-of-Review-Period-for-DCCR-Diazoxide-Choline-Extended-Release-Tablets-in-Prader-Willi-Syndrome.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["SLNO","PWS","BK4139"],"gpt_icon":0},{"id":"2485209994","title":"Here are 4 biotech stocks that could get a boost from Trump's new regulatory climate","url":"https://stock-news.laohu8.com/highlight/detail?id=2485209994","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2485209994?lang=en_us&edition=fundamental","pubTime":"2024-11-23 21:44","pubTimestamp":1732369440,"startTime":"0","endTime":"0","summary":"Biotech-stock investing has one tough test for success - and it's about to get easier. The key to successful biotech investing is straightforward: Own stocks of companies that get drugs approved. That hasn't been so easy. But the U.S. Food & Drug Administration  has become more flexible about granting new drug approvals, and drugs for rare diseases in particular - which could boost the shares of the four promising biotech firms discussed below.\"Right now, the FDA is at peak flexibility,\" Baird biotech analyst Brian Skorney said in a recent interview. \"The FDA has demonstrated more flexibility every year, over the past 10 years.\". \"There are plenty of drugs that generate a lot of revenue even though there are questions about whether they really work,\" Skorney said.Instead of using clinical benefit as the benchmark, the FDA approved Oxbryta based on studies that showed it reduced a biomarker for the disorder, Skorney said. \"It was a controversial approval decision because of questions ab","market":"sg","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["IE00BBT3K403.USD","LU0306807586.USD","BK4550","IE0002270589.USD","LU1894683264.USD","PTCT","LU0889565916.HKD","LU0109394709.USD","BK4599","PWS","BHVN","BK4568","BK4534","LU0225284248.USD","LU0306806265.USD","SG9999011175.SGD","PFE","BK4585","IE00B19Z3B42.SGD","CMS","LU0058720904.USD","LU0985481810.HKD","LU0321505439.SGD","LU2346227817.USD","IE00B19Z3581.USD","BK4007","LU0321505868.SGD","LU1066053197.SGD","SG9999003800.SGD","BK4592","LU1883839398.USD","SG9999002224.SGD","IE00BLSP4452.SGD","LU0234572021.USD","IE00BLSP4239.USD","LU0456855351.SGD","LU1023059063.AUD","APLT","BK4139","BK4208","SGXZ57979304.SGD","SG9999002232.USD","LU1093756325.SGD","LU1066051498.USD","LU0225771236.USD","LU1894683348.USD","LU2637428348.USD","IE000M9KFDE8.USD","BK4581","SLNO"],"gpt_icon":1},{"id":"2484717309","title":"Here are 4 biotech stocks that could get a boost from Trump's new regulatory climate","url":"https://stock-news.laohu8.com/highlight/detail?id=2484717309","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484717309?lang=en_us&edition=fundamental","pubTime":"2024-11-20 03:04","pubTimestamp":1732043040,"startTime":"0","endTime":"0","summary":"Biotech-stock investing has one tough test for success - and it's about to get easier. The key to successful biotech investing is straightforward: Own stocks of companies that get drugs approved. That hasn't been so easy. But the U.S. Food & Drug Administration  has become more flexible about granting new drug approvals, and drugs for rare diseases in particular - which could boost the shares of the four promising biotech firms discussed below.\"Right now, the FDA is at peak flexibility,\" Baird biotech analyst Brian Skorney said in a recent interview. \"The FDA has demonstrated more flexibility every year, over the past 10 years.\". \"There are plenty of drugs that generate a lot of revenue even though there are questions about whether they really work,\" Skorney said.Instead of using clinical benefit as the benchmark, the FDA approved Oxbryta based on studies that showed it reduced a biomarker for the disorder, Skorney said. \"It was a controversial approval decision because of questions ab","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU1057294990.SGD","SG9999003800.SGD","LU1066053197.SGD","PWS","PFE","LU1023059063.AUD","PTCT","SG9999002232.USD","BK4568","IE00B19Z3B42.SGD","BHVN","BK4581","BK4139","LU0321505868.SGD","BK4585","LU0868494617.USD","LU0109394709.USD","LU0320765992.SGD","LU1883839398.USD","LU2637428348.USD","BK4588","IE00BLSP4239.USD","LU0122379950.USD","SG9999001176.USD","SG9999011175.SGD","CMS","LU1093756325.SGD","LU1093756168.USD","SLNO","BK4534","SGXZ57979304.SGD","LU2346227817.USD","SG9999002224.SGD","LU0306807586.USD","BK4533","LU0289739699.SGD","LU0985481810.HKD","LU0456855351.SGD","IE000M9KFDE8.USD","LU0225771236.USD","IE00B19Z3581.USD","IE00BBT3K403.USD","IE0002270589.USD","LU1894683264.USD","LU0058720904.USD","LU0889565916.HKD","LU0170899867.USD","APLT","LU0321505439.SGD","SG9999001176.SGD"],"gpt_icon":1},{"id":"2484621244","title":"Biotech-stock investing has one tough test for success - and it's about to get easier","url":"https://stock-news.laohu8.com/highlight/detail?id=2484621244","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484621244?lang=en_us&edition=fundamental","pubTime":"2024-11-18 20:41","pubTimestamp":1731933660,"startTime":"0","endTime":"0","summary":"Here are 4 biotech stocks that could get a boost from a more open FDA regulatory climate. The key to successful biotech investing is straightforward: Own stocks of companies that get drugs approved. That hasn't been so easy. But the U.S. Food & Drug Administration  has become more flexible about granting new drug approvals, and drugs for rare diseases in particular - which could boost the shares of the four promising biotech firms discussed below.\"Right now, the FDA is at peak flexibility,\" Baird biotech analyst Brian Skorney said in a recent interview. \"The FDA has demonstrated more flexibility every year, over the past 10 years.\". \"There are plenty of drugs that generate a lot of revenue even though there are questions about whether they really work,\" Skorney said.Instead of using clinical benefit as the benchmark, the FDA approved Oxbryta based on studies that showed it reduced a biomarker for the disorder, Skorney said. \"It was a controversial approval decision because of questions","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU0289739699.SGD","LU0456855351.SGD","BK4007","LU0321505868.SGD","LU0225771236.USD","LU1894683264.USD","BK4139","LU0320765992.SGD","LU1066053197.SGD","LU1093756168.USD","LU0306806265.USD","BK4592","LU0306807586.USD","LU0985481810.HKD","LU0122379950.USD","LU0234572021.USD","SG9999011175.SGD","SLNO","LU0868494617.USD","BK4588","LU2346227817.USD","LU1883839398.USD","SG9999013999.USD","IE00BLSP4452.SGD","APLT","LU0170899867.USD","BK4208","LU0225284248.USD","IE00B19Z3B42.SGD","LU0109394709.USD","CMS","BHVN","BK4581","PTCT","SG9999001176.SGD","PWS","LU0321505439.SGD","SG9999002224.SGD","BK4568","IE0002270589.USD","LU1066051498.USD","LU1894683348.USD","SGXZ57979304.SGD","SG9999001176.USD","BK4550","PFE","IE00BLSP4239.USD","IE000M9KFDE8.USD","LU1023059063.AUD","LU1093756325.SGD"],"gpt_icon":1},{"id":"2483833763","title":"Soleno Therapeutics Announces Oral Presentations Featuring Diazoxide Choline Extended-Release (Dccr) Tablets in Prader-Willi Syndrome at Espe 2024","url":"https://stock-news.laohu8.com/highlight/detail?id=2483833763","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2483833763?lang=en_us&edition=fundamental","pubTime":"2024-11-15 05:05","pubTimestamp":1731618302,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20241114:nTUAC2HV9R:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["SLNO","BK4139"],"gpt_icon":0},{"id":"2483133089","title":"Soleno Therapeutics Announces Oral Presentations featuring Diazoxide Choline Extended-Release (DCCR) Tablets in Prader-Willi Syndrome at ESPE 2024","url":"https://stock-news.laohu8.com/highlight/detail?id=2483133089","media":"GlobeNewswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2483133089?lang=en_us&edition=fundamental","pubTime":"2024-11-15 05:05","pubTimestamp":1731618300,"startTime":"0","endTime":"0","summary":"REDWOOD CITY, Calif., Nov.  14, 2024  (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatmen","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.globenewswire.com/news-release/2024/11/14/2981587/0/en/Soleno-Therapeutics-Announces-Oral-Presentations-featuring-Diazoxide-Choline-Extended-Release-DCCR-Tablets-in-Prader-Willi-Syndrome-at-ESPE-2024.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["PWS","SLNO","BK4139"],"gpt_icon":1},{"id":"2482772889","title":"Here's Why We're Not At All Concerned With Soleno Therapeutics' (NASDAQ:SLNO) Cash Burn Situation","url":"https://stock-news.laohu8.com/highlight/detail?id=2482772889","media":"Simply Wall St.","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2482772889?lang=en_us&edition=fundamental","pubTime":"2024-11-12 18:38","pubTimestamp":1731407886,"startTime":"0","endTime":"0","summary":"Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the right price. For example, Soleno Therapeutics  shareholders have done very well over the last year, with the share price soaring by 168%. But while history lauds those rare successes, those that fail are often forgotten; who remembers Pets.com?So notwithstanding the buoyant share price, we think it's well worth asking whether Soleno Therapeutics' cash burn is too risky. For the purpose of this article, we'll define cash burn as the amount of cash the company is spending each year to fund its growth . We'll start by comparing its cash burn with its cash reserves in order to calculate its cash runway.How Is Soleno Therapeutics' Cash Burn Changing Over Time?Soleno Therapeutics has a market capitalisation of US$2.5b and burnt through US$52m last year, which is 2.1% of the company's market value. That means it could easily issue a few 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