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Champion Industries, Inc.

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Overview Company News Filings

Pharma Stock Roundup: FDA Nod to SNY, AZN & NVS, JNJ Talc Suits Failure

Akebia announces CHMP positive opinion for XOANACYL

Akebia Therapeutics Announces Positive Opinion of European Medicines Agency for XOANACYL®, an Oral Therapy for Chronic Kidney Disease Licensed to Averoa

AstraZeneca's Imfinzi Gets FDA Nod for Bladder Cancer Indication

The European Commission refers lecanemab decision to Appeal Committee

European Commission Approves Pfizer’s RSV Vaccine ABRYSVO® to Help Protect Adults Aged 18-59 Against RSV Lower Respiratory Tract Disease

BeiGene receives positive CHMP opinion for Tevimbra

BeiGene Receives Positive CHMP Opinion for TEVIMBRA® as a First-Line Treatment for Extensive-Stage Small Cell Lung Cancer

CHMP Recommends Against Approval of Eli Lilly's Kisunla Alzheimer's Drug -- Update

Bristol Myers Gets CHMP Backing for Subcutaneous Opdivo

Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications

Crinetics Pharmaceuticals Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) and Orphan Drug Designation (ODD) for Paltusotine in Acromegaly

Press Release: Valneva Reports Full Year 2024 Results and Provides Business Updates and Outlook

Rxulti® (brexpiprazole) approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older

Regeneron Pharmaceuticals, Inc. (REGN): Hedge Funds Are Bullish On This Oversold Blue Chip Stock Now

WAINZUA (eplontersen) approved in the EU for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy

Theriva™ Biologics Reports Full-Year 2024 Operational Highlights and Financial Results

Bavarian Nordic Publishes Annual Report 2024

Regeneron Gets Positive CHMP Opinion for Multiple Myeloma Drug

KRYS Gets Positive CHMP Opinion for EU Approval of Skin Disease Drug

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One of the best stock trading platforms in Singapore.","ogImage":"https://c1.itigergrowtha.com/portal5/static/media/og-logo.be62fbe1.png","ogUrl":"https://www.itiger.com/stock/CHMP/news"},"companyName":"Tiger Brokers"},"pageData":{"isMobile":false,"isTiger":false,"isTTM":true,"region":"SGP","license":"TBSG","edition":"fundamental","symbol":"CHMP","isAnalysisPage":false},"__swrFallback__":{"@#url:\"https://hq.skytigris.cn/stock_info/detail/global\",params:#delay:false,,method:\"POST\",data:#items:@#symbol:\"CHMP\",,,,,undefined,":{"symbol":"CHMP","market":"US","secType":"STK","nameCN":"Champion Industries, Inc.","latestPrice":0.0001,"timestamp":1744920000000,"preClose":0.0001,"halted":0,"volume":0,"delay":15,"floatShares":0,"shares":55857,"eps":-23.033406,"marketStatus":"Closed Good Friday","change":0,"latestTime":"04-17 16:00:00 EDT Delay","open":0.0001,"high":0.0001,"low":0.0001,"amount":0,"amplitude":0,"askPrice":0,"askSize":0,"bidPrice":0,"bidSize":0,"shortable":3,"etf":0,"otc":true,"ttmEps":-23.033406,"tradingStatus":0,"nextMarketStatus":{"tag":"Pre-Mkt","tradingStatus":1,"beginTime":1745222400000},"marketStatusCode":7,"adr":0,"adrRate":0,"exchange":"EXPERT","adjPreClose":0.0001,"volumeRatio":2.7777835648268714},"@#url:\"https://hq.skytigris.cn/stock_info/fundamental/all\",params:#delay:false,,method:\"POST\",data:#items:@#symbol:\"CHMP\",,,,,undefined,":{"symbol":"CHMP","floatShares":0,"roa":"-1.87%","roe":"-49.45%","lyrEps":-23.033406,"volumeRatio":2.7777835648268714,"shares":55857,"dividePrice":0,"high":0.0001,"amplitude":0,"preClose":0.0001,"low":0.0001,"week52Low":0.0001,"pbRate":"0.00","psRate":"0.00","week52High":0.0001,"institutionHeld":0,"latestPrice":0.0001,"eps":-23.033406,"divideRate":0,"volume":0,"delay":15,"ttmEps":-23.033406,"open":0.0001,"prevYearClose":0.0001,"prevWeekClose":0.0001,"prevMonthClose":0.0001,"prevQuarterClose":0.0001,"fiveDayClose":0.0001,"twentyDayClose":0.0001,"sixtyDayClose":0.0001},"$inf$@#url:\"https://stock-news.skytigris.cn/v2/news/list\",params:#symbols:\"CHMP\",pageSize:20,pageCount:1,lang_content:\"en\",edition:\"fundamental\",,,undefined,":[{"items":[{"id":"2524784382","title":"Pharma Stock Roundup: FDA Nod to SNY, AZN & NVS, JNJ Talc Suits Failure","url":"https://stock-news.laohu8.com/highlight/detail?id=2524784382","media":"Zacks","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524784382?lang=en_us&edition=fundamental","pubTime":"2025-04-04 21:46","pubTimestamp":1743774360,"startTime":"0","endTime":"0","summary":"This week, the FDA approved Sanofi’s SNY hemophilia therapy, fitusiran, Novartis’ NVS Vanrafia for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy and the expanded use of AstraZeneca’s AZN blockbuster cancer drug, Imfinzi. J&J’s JNJ bankruptcy strategy to settle talc lawsuits failed for the third time. The European Commission approved Pfizer’s PFE respiratory syncytial virus vaccine, Abrysvo, for use in adults aged 18 through 59 years.Here's a recap of the week’s most important stories.Texas Court Rejects J&J’s Bankruptcy Attempt to End Talc Suits. A bankruptcy court in Texas rejected J&J’s proposed bankruptcy plan to settle claims related to its talc lawsuits for the third time. In September, J&J, via a subsidiary called Red River Talc, filed for voluntary bankruptcy in the Southern District of Texas after it received the support of around 83% of current claimants for the proposed bankruptcy plan, which was above the 75% required by the U.S. bankruptcy","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://finance.yahoo.com/news/pharma-stock-roundup-fda-nod-134600557.html","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":"yahoofinance","symbols":["IE00B1BXHZ80.USD","LU1430594728.SGD","SNY","SG9999013999.USD","SG9999001176.USD","LU2129689605.HKD","LU1674673691.USD","BK4599","IE00BVYPNW00.USD","NVS","CHMP","PFE","LU1261432733.SGD","IE00BJT1NW94.SGD","LU2112291526.USD","LU0868494617.USD","LU0320765992.SGD","SG9999001440.SGD","AZN","LU0225284248.USD","LU2129689431.USD","LU0070302665.USD","LU0912757837.SGD","BK4533","LU0345770993.USD","LU2602419157.SGD","LU1585245621.USD","LU0345770308.USD","IE00BSNM7G36.USD","LU1267930813.SGD","LU0058720904.USD","JNJ","LU1778281490.HKD","LU1894683264.USD","LU2133065610.SGD","BK4532","LU0306807586.USD","IE00B3PB1722.GBP","IE00BLSP4239.USD","IE00B2B36J28.USD","LU0114720955.EUR","LU0289739699.SGD","LU0985320562.USD","LU2430703178.SGD","LU2592432038.USD","LU1732799900.SGD","LU1280957306.USD","BK4585","LU1244550221.USD","LU0889566641.SGD"],"gpt_icon":1},{"id":"2524259864","title":"Akebia announces CHMP positive opinion for XOANACYL","url":"https://stock-news.laohu8.com/highlight/detail?id=2524259864","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524259864?lang=en_us&edition=fundamental","pubTime":"2025-04-03 20:12","pubTimestamp":1743682322,"startTime":"0","endTime":"0","summary":"Akebia (AKBA) Therapeutics announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positiv...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/akebia-announces-chmp-positive-opinion-for-xoanacyl?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/akebia-announces-chmp-positive-opinion-for-xoanacyl?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["BK4087","BK4139","CHMP","AKBA"],"gpt_icon":0},{"id":"2524725981","title":"Akebia Therapeutics Announces Positive Opinion of European Medicines Agency for XOANACYL®, an Oral Therapy for Chronic Kidney Disease Licensed to Averoa","url":"https://stock-news.laohu8.com/highlight/detail?id=2524725981","media":"GlobeNewswire","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524725981?lang=en_us&edition=fundamental","pubTime":"2025-04-03 20:00","pubTimestamp":1743681600,"startTime":"0","endTime":"0","summary":"CAMBRIDGE, Mass., April 03, 2025  -- Akebia Therapeutics, Inc. , a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the Committee for Medicinal Products for Human Use  of the European Medicines Agency  has adopted a positive opinion recommending the European Commission  to approve XOANACYL  for the treatment of concomitant elevated serum phosphorous and iron deficiency in adult patients with chronic kidney disease .“We congratulate our partner Averoa on a positive step toward securing EMA approval for XOANACYL, and we will continue to support their efforts to deliver a treatment for complications of kidney disease to patients in Europe,” said John P. Butler, Chief Executive Officer of Akebia.The EC will review the CHMP recommendation, and a final decision is expected in approximately two months.About Akebia TherapeuticsAkebia Therapeutics, Inc.is a fully integrated biopharmaceutical company with the purpose to bet","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://finance.yahoo.com/news/akebia-therapeutics-announces-positive-opinion-120000568.html","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":"yahoofinance","symbols":["BK4087","BK4201","BK4139","CHMP","AKBA","MDCO","EC"],"gpt_icon":0},{"id":"2524917146","title":"AstraZeneca's Imfinzi Gets FDA Nod for Bladder Cancer Indication","url":"https://stock-news.laohu8.com/highlight/detail?id=2524917146","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524917146?lang=en_us&edition=fundamental","pubTime":"2025-04-01 21:31","pubTimestamp":1743514260,"startTime":"0","endTime":"0","summary":"AstraZenecaAZN announced that the FDA has approved its blockbuster drug, Imfinzi, for a bladder cancer indication in the United States.Imfinzi is approved in combination with gemcitabine and cisplatin as a neoadjuvant treatment for muscle-invasive bladder cancer , a type of bladder cancer that has spread into the muscle wall of the bladder. The regulatory filing for the drug was reviewed under the FDA’s Priority Review Pathway. This marks the first approval for Imfinzi for a bladder cancer indication.AstraZeneca’s Imfinzi, either as a monotherapy or in combination with chemotherapy, is presently approved for stage III non-small cell lung cancer, extensive-stage small cell lung cancer, locally advanced or metastatic biliary tract cancer and endometrial cancer that is mismatch repair deficient and in combination with Imjudo in unresectable hepatocellular carcinoma in some countries. The drug has also recently been approved for limited-stage small cell lung cancer in the United States and","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://finance.yahoo.com/news/astrazenecas-imfinzi-gets-fda-nod-133100339.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["LU1829250122.USD","DVAX","AZN","LU2456880835.USD","LU0889565916.HKD","BK4532","LU1559883803.SGD","LU2462157665.USD","BK4139","BK4568","LU2236285917.USD","BK4087","BK4585","LU0109394709.USD","BK4007","BK4588","BAYRY","LU0566484027.USD","LU2417539215.USD","CHMP","CORT","LU0320765992.SGD"],"gpt_icon":0},{"id":"2524219948","title":"The European Commission refers lecanemab decision to Appeal Committee","url":"https://stock-news.laohu8.com/highlight/detail?id=2524219948","media":"PR Newswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524219948?lang=en_us&edition=fundamental","pubTime":"2025-04-01 18:17","pubTimestamp":1743502620,"startTime":"0","endTime":"0","summary":"STOCKHOLM, April 1, 2025 /PRNewswire/ --BioArctic AB's   partner Eisai today announced that the European Commission  has decided to refer the marketing authorisation approval decision of lecanemab in the EU to the Appeal Committee.If the marketing authorization application for lecanemab is approved, the approval will apply to all 27 European Union member states, as well as Iceland, Liechtenstein, and Norway. Leqembi is already approved in the US, Japan, China, Great Britain and other markets.Lecanemab is approved in the U.S., Japan, China, United Kingdom, and several other markets for the treatment of mild cognitive impairment  due to Alzheimer's disease  and mild AD dementia. Lecanemab's approvals in these countries, as well as the CHMP's positive opinion in November 2024, were primarily based on Phase 3 data from Eisai's global Clarity AD clinical trial, in which it met its primary endpoint and all key secondary endpoints with statistically significant results. Eisai has also submitt","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/european-commission-refers-lecanemab-decision-101700021.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/european-commission-refers-lecanemab-decision-101700021.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":"yahoofinance","symbols":["BK4585","EC","BRCTF","MCI","BK4087","BK4139","MAA","BK4215","BK4201","CHMP","BK4588"],"gpt_icon":0},{"id":"2524016956","title":"European Commission Approves Pfizer’s RSV Vaccine ABRYSVO® to Help Protect Adults Aged 18-59 Against RSV Lower Respiratory Tract Disease","url":"https://stock-news.laohu8.com/highlight/detail?id=2524016956","media":"Business Wire","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524016956?lang=en_us&edition=fundamental","pubTime":"2025-04-01 15:00","pubTimestamp":1743490800,"startTime":"0","endTime":"0","summary":"ABRYSVO is the first and only RSV vaccine approved in the European Union  for non-pregnant adults aged 18-49. NEW YORK, April 01, 2025----Pfizer Inc.  announced today that the European Commission  has issued a decision amending the marketing authorization for ABRYSVO, the company’s bivalent respiratory syncytial virus  prefusion F  vaccine, to extend the indication to include prevention of lower respiratory tract disease  caused by RSV in individuals 18 through 59 years of age. This expands the previous authorization for individuals aged 60 and older, and ABRYSVO now offers in the EU the broadest RSV vaccine indication, which includes:. Active immunization of individuals 18 years of age and older for the prevention of LRTD caused by RSV. ABOUT RSVRespiratory Syncytial Virus  is a contagious virus and a common cause of respiratory illness worldwide.5 The virus can affect the lungs and breathing passages of an infected individual, potentially causing severe illness or death.6,7,8 There a","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":"b03cb07231ec101993964453ca7b8fef","theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/european-commission-approves-pfizer-rsv-070000511.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["LU0321505868.SGD","BK4550","BK4581","LU0225771236.USD","BK4201","BK4568","LU0058720904.USD","LU0170899867.USD","SGXZ57979304.SGD","EC","BK4599","LU1057294990.SGD","IE00B19Z3581.USD","LU0321505439.SGD","LU1066053197.SGD","CHMP","BK4156","BK4099","IE000M9KFDE8.USD","LU0306807586.USD","LU1883839398.USD","BK4574","LU1894683264.USD","BK4087","LU0456855351.SGD","SG9999002232.USD","BK4585","LU1894683348.USD","SG9999003800.SGD","SG9999001176.SGD","LU0985481810.HKD","LU0289739699.SGD","BK4534","BK4592","PFE","SG9999002224.SGD","LU0868494617.USD","BK4533","IE0002270589.USD","BK4007","BK4588","BK4516","SG9999011175.SGD","LU0234572021.USD","F","LU0122379950.USD","BK4555","IE00BLSP4239.USD","SG9999013999.USD"],"gpt_icon":1},{"id":"2523911154","title":"BeiGene receives positive CHMP opinion for Tevimbra","url":"https://stock-news.laohu8.com/highlight/detail?id=2523911154","media":"TIPRANKS","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2523911154?lang=en_us&edition=fundamental","pubTime":"2025-03-31 18:15","pubTimestamp":1743416138,"startTime":"0","endTime":"0","summary":"BeiGene (ONC) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommen...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/beigene-receives-positive-chmp-opinion-for-tevimbra?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/beigene-receives-positive-chmp-opinion-for-tevimbra?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["ONC","BK4139","BK4087","CHMP"],"gpt_icon":0},{"id":"2523141809","title":"BeiGene Receives Positive CHMP Opinion for TEVIMBRA® as a First-Line Treatment for Extensive-Stage Small Cell Lung Cancer","url":"https://stock-news.laohu8.com/highlight/detail?id=2523141809","media":"Business Wire","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2523141809?lang=en_us&edition=fundamental","pubTime":"2025-03-31 18:00","pubTimestamp":1743415200,"startTime":"0","endTime":"0","summary":"Positive opinion for first-line treatment of extensive-stage small cell lung cancer based on results of RATIONALE-312 study demonstrating statistically significant overall survival benefit for TEVIMBRA in combination with chemotherapy. SAN CARLOS, Calif., March 31, 2025----BeiGene, Ltd. , a global oncology company that intends to change its name to BeOne Medicines Ltd., today announced that the Committee for Medicinal Products for Human Use  of the European Medicines Agency issued a positive opinion recommending approval of TEVIMBRA , in combination with etoposide and platinum chemotherapy, as a first-line treatment for adult patients with extensive-stage small cell lung cancer .\"The aggressive nature of extensive-stage small cell lung cancer makes it an extremely difficult type of lung cancer to treat, and currently available treatments may not adequately control disease progression,\" said Prof. Silvia Novello, M.D., Ph.D., President Women Against Lung Cancer in Europe  and Head of Me","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://finance.yahoo.com/news/beigene-receives-positive-chmp-opinion-100000003.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["CHMP","BK4087","SSI","ONC","BK4139","BK4097","ITT","BK4161","OS","LU0053671581.USD","LU0054578231.USD"],"gpt_icon":0},{"id":"2522502571","title":"CHMP Recommends Against Approval of Eli Lilly's Kisunla Alzheimer's Drug -- Update","url":"https://stock-news.laohu8.com/highlight/detail?id=2522502571","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2522502571?lang=en_us&edition=fundamental","pubTime":"2025-03-28 23:45","pubTimestamp":1743176700,"startTime":"0","endTime":"0","summary":"A key European regulatory committee has recommended against approval of Eli Lilly's Kisunla, saying the benefits of the Alzheimer's disease drug don't outweigh its risks.The European Medicines Agency's Committee for Medicinal Products for Human Use on Friday adopted a negative opinion on Kisunla, citing the risk of potentially fatal events due to amyloid-related imaging abnormalities, involving swelling and potential bleeding in the brain.Eli Lilly, which is seeking European approval of Kisunla for the treatment of early symptomatic Alzheimer's, said it will seek re-examination by CHMP.The Indianapolis drugmaker said it remains confident in the safety and effectiveness of the drug and the value it can bring to patients with early symptomatic Alzheimer's.The U.S. Food and Drug Administration last year approved Kisunla, an antibody drug given as a monthly intravenous infusion that studies show has slowed the progression of the memory-robbing disease.The CHMP last July recommended against","market":"fut","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":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["IE00BJT1NW94.SGD","LU0471298777.SGD","LU2264538146.SGD","LU2089984988.USD","IE00BFTCPJ56.SGD","LU0203202063.USD","SG9999001176.SGD","LU1057294990.SGD","IE0004445239.USD","CHMP","LU1988902786.USD","LU0094547139.USD","LU0256863811.USD","LU1814569148.SGD","BK4599","LU1720051017.SGD","LU0354030511.USD","LU1093756168.USD","LU0198837287.USD","LU2491050071.SGD","LU0109391861.USD","IE00BK4W5M84.HKD","LU0417517546.SGD","LU1868837136.USD","SG9999013999.USD","LU1035775433.USD","LU1267930730.SGD","SG9999015952.SGD","BK4007","LU0640476718.USD","LU0689472784.USD","LU1917777945.USD","LU1804176565.USD","LU1551013425.SGD","SGXZ51526630.SGD","IE00B2B36J28.USD","BK4534","LU1551013342.USD","LU0006306889.USD","SG9999018857.SGD","LLY","LU0097036916.USD","LU0823416689.USD","LU1720051108.HKD","LU2237443978.SGD","LU2357305700.SGD","BK4585","SGXZ99366536.SGD","BK4588","LU0820561818.USD"],"gpt_icon":0},{"id":"2522760905","title":"Bristol Myers Gets CHMP Backing for Subcutaneous Opdivo","url":"https://stock-news.laohu8.com/highlight/detail?id=2522760905","media":"Dow Jones","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2522760905?lang=en_us&edition=fundamental","pubTime":"2025-03-28 20:34","pubTimestamp":1743165240,"startTime":"0","endTime":"0","summary":"Bristol Myers Squibb said a key European regulatory committee is backing a formulation of its blockbuster cancer drug Opdivo that can be injected under the skin.Bristol Myers on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval of a subcutaneous formulation of Opdivo across multiple previously approved adult solid tumors as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy combination therapy, or in combination with chemotherapy or cabozantinib.The Princeton, N.J., biopharmaceutical company said the European Commission, which generally follows CHMP's advice, will now review the recommendation, with a decision expected by June 2.Opdivo, which harnesses the body's own immune system to fight cancer and generated more than $9.3 billion in revenue last year, is currently administered intravenously in Europe.The U.S. Food and Drug Administration approved the subcutaneous formulation of Opdivo late las","market":"sh","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":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4588","LU1868836591.USD","MYE","LU1868836914.USD","IE00BJJMRZ35.SGD","LU0321505439.SGD","LU1868836757.USD","IE0009355771.USD","LU1868837136.USD","LU0306806265.USD","LU1032466523.USD","LU1291159041.SGD","LU1670710588.SGD","CHMP","IE00BJT1NW94.SGD","BMY","LU0237698245.USD","BK4534","LU1093756325.SGD","LU1670710661.SGD","BK4007","LU0868494617.USD","LU2125154778.USD","LU0225284248.USD","BK4087","LU1093756168.USD","LU1571399168.USD","IE00BFTCPJ56.SGD","LU2125154935.USD","LU1585245621.USD","LU1670711123.USD","IE00BSNM7G36.USD","LU0061475181.USD","BK4126","LU1868837300.USD","LU2133065610.SGD","BK4532","LU0306807586.USD","IE00B2B36J28.USD","LU0985481810.HKD","LU1670711040.USD","LU1323610961.USD","LU2242646821.SGD","BK4581","LU0321505868.SGD","IE0002141913.USD","LU0882574055.USD","BK4585","LU1989771016.USD","LU2360032135.SGD"],"gpt_icon":0},{"id":"2522257316","title":"Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo® (nivolumab) Across Multiple Solid Tumor Indications","url":"https://stock-news.laohu8.com/highlight/detail?id=2522257316","media":"Business Wire","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2522257316?lang=en_us&edition=fundamental","pubTime":"2025-03-28 20:00","pubTimestamp":1743163200,"startTime":"0","endTime":"0","summary":"Recommendation is based primarily on results from the Phase 3 CheckMate -67T trial which demonstrated noninferiority in the co-primary endpoints of Cavgd28 and Cminss and consistent efficacy in the secondary endpoint of overall response rate for the subcutaneous formulation of Opdivo vs. its intravenous formulation. A decision on the EU Opdivo extension of marketing authorization is expected by June 2, 2025. \"The positive CHMP opinion is an important step forward in the evolution of immuno-oncology and in the potential of subcutaneous nivolumab to help transform the lives of people living with cancer,\" said Dana Walker, M.D., M.S.C.E., Opdivo global program lead, Bristol Myers Squibb. \"We look forward to bringing the same high-quality care that transformed cancer treatment with an administration method that has the potential to improve the patient experience and efficiency of healthcare systems in Europe.\"","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://finance.yahoo.com/news/bristol-myers-squibb-receives-positive-120000105.html","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":"yahoofinance","symbols":["EC","BK4156","BK4500","LU0061475181.USD","LU1670711040.USD","ALK","IE0002141913.USD","BK4007","LU0306807586.USD","LU1074936037.SGD","CRT","VOD","ORR","LU0321505439.SGD","LU1291159041.SGD","EEA","LU1718418525.SGD","BK4585","LU1093756325.SGD","HSCT","LU1093756168.USD","LU1670710588.SGD","LU1670711123.USD","LU1323610961.USD","BK4559","LU1670710661.SGD","IE0009355771.USD","UK","LU0096364046.USD","IE00BFTCPJ56.SGD","TEN","BK4532","LU0868494617.USD","LU2133065610.SGD","MYE","LU1032466523.USD","BK4534","BK4528","BK4008","LU2242652126.USD","LU0456855351.SGD","BMY","RCC","CHMP","LU1261432733.SGD","LU0882574055.USD","LU1868836914.USD","IE00BJJMRZ35.SGD","LU0237698245.USD"],"gpt_icon":0},{"id":"2522532250","title":"Crinetics Pharmaceuticals Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) and Orphan Drug Designation (ODD) for Paltusotine in Acromegaly","url":"https://stock-news.laohu8.com/highlight/detail?id=2522532250","media":"GlobeNewswire","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2522532250?lang=en_us&edition=fundamental","pubTime":"2025-03-28 04:05","pubTimestamp":1743105900,"startTime":"0","endTime":"0","summary":"SAN DIEGO, March 27, 2025  -- Crinetics Pharmaceuticals, Inc.  today announced that the European Medicines Agency  has validated the Marketing Authorization Application  for paltusotine, the first once-daily, oral, selectively-targeted somatostatin receptor type 2 nonpeptide agonist, for the proposed treatment and long-term maintenance therapy of acromegaly, a serious, rare and progressive endocrine disorder characterized by consistently elevated levels of growth hormone. The MAA will now be reviewed by the Committee for Medicinal Products for Human Use . Additionally, the EMA on February 27, 2025 granted paltusotine Orphan Drug Designation  for the treatment of acromegaly.The EMA grants orphan designation to medicines intended for the treatment, prevention, or diagnosis of life-threatening or chronically debilitating diseases affecting no more than 5 in 10,000 people in the European Union, among other criteria. The medicine must also provide significant benefit to those affected by th","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://finance.yahoo.com/news/crinetics-pharmaceuticals-announces-european-medicines-200500366.html","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":"yahoofinance","symbols":["GH","CRNX","BK4087","BK4535","BK4196","BK4183","BK4588","MDCO","MAA","BK4215","CHMP","BK4551","BK4585","BK4139","ODD"],"gpt_icon":0},{"id":"2520172076","title":"Press Release: Valneva Reports Full Year 2024 Results and Provides Business Updates and Outlook","url":"https://stock-news.laohu8.com/highlight/detail?id=2520172076","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2520172076?lang=en_us&edition=fundamental","pubTime":"2025-03-20 14:00","pubTimestamp":1742450400,"startTime":"0","endTime":"0","summary":"-- Met 2024 growth targets for product sales  and total. -- Strong year-end cash position of EUR168.3 million including sale of. Priority Review Voucher1, successful private placement and 67% reduction. -- Substantial clinical and regulatory progress in 2024; further data. readouts, product approvals and label extensions anticipated in 2025. -- 2025 outlook reflects solid revenue growth and positive commercial cash. flows to support strategic R&D investments with lower operating cash burn. Saint-Herblain , March 20, 2025 -- Valneva SE , a specialty vaccine company, today reported its consolidated financial results for the year ended December 31, 2024 and provided key corporate updates and guidance for its future results. The consolidated financial results are available on the Company's website .-- Product sales reached EUR163.3 million for the year ended December 31,2024 compared to EUR144.6 million in the same period of 2023, an increase. compared to EUR153.7 million for the year ende","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":["BK4139","VALN","BK4087","CHMP","BK4022","BK4539","SII","BK4232","CHIM","BK4135","CEPI","R"],"gpt_icon":0},{"id":"2519007017","title":"Rxulti® (brexpiprazole) approved in the European Union for the treatment of schizophrenia in adolescents aged 13 years and older","url":"https://stock-news.laohu8.com/highlight/detail?id=2519007017","media":"PR Newswire","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2519007017?lang=en_us&edition=fundamental","pubTime":"2025-03-13 16:45","pubTimestamp":1741855500,"startTime":"0","endTime":"0","summary":"Brexpiprazole's indication for the treatment of schizophrenia in adults is extended to include adolescents aged 13 years and older1. Approval follows a positive Committee for Medicinal Products for Human Use  opinion from the European Medicines Agency in January 20252. Treatment with brexpiprazole  significantly reduced the symptoms of schizophrenia as measured by PANSS total score compared to placebo3. WINDSOR, England and VALBY, Denmark, March 13, 2025 /PRNewswire/ --Otsuka Pharmaceutical Europe Ltd.  and H. Lundbeck A/S  today announced that the European Commission  has approved Rxulti for the treatment of schizophrenia in adolescents aged 13 years and older.1 Brexpiprazolewas previously approved in the European Union in 2018 for the treatment of schizophrenia in adults.4. Brexpiprazole was discovered by Otsuka and is being co-developed and co-commercialised under a collaboration and license agreement between Otsuka Pharmaceutical Europe Ltd. a","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/rxulti-brexpiprazole-approved-european-union-084500819.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/rxulti-brexpiprazole-approved-european-union-084500819.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["EC","BK4007","HLUBF","CHMP","BK4201","HLBBF","BK4087"],"gpt_icon":0},{"id":"2518787414","title":"Regeneron Pharmaceuticals, Inc. (REGN): Hedge Funds Are Bullish On This Oversold Blue Chip Stock Now","url":"https://stock-news.laohu8.com/highlight/detail?id=2518787414","media":"Insider Monkey","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2518787414?lang=en_us&edition=fundamental","pubTime":"2025-03-11 07:29","pubTimestamp":1741649368,"startTime":"0","endTime":"0","summary":"We recently compiled a list of the 11 Oversold Blue Chip Stocks to Buy According to Hedge Funds.In this article, we are going to take a look at where Regeneron Pharmaceuticals, Inc.  stands against the other oversold blue chip stocks.As per Franklin Templeton, the US equities have managed to provide strong gains over the past few years, with the S&P 500 repeatedly touching record highs, thanks to the Magnificent Seven’s dominance in AI. Despite elevated valuations, the broader market outlook is positive. Innovation and investment continue at a pace, sales growth has been accelerating, and earnings are expected to see a double-digit rise this year. Also, the US economy has a more business-friendly administration. That being said, there are risks, mainly related to the US trade policy and the expected impact of tariffs on critical sectors, including technology.Amidst such uncertainties, Franklin Templeton believes that investor confidence in the US equities is expected to remain strong. ","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://finance.yahoo.com/news/regeneron-pharmaceuticals-inc-regn-hedge-232928433.html","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":"yahoofinance","symbols":["BK4534","BK4087","BK4588","VOO","PSQ","BK4581","LU1974910355.USD","LU0053666078.USD","LU2023250504.SGD","QLD","REGN","CHMP","LU2468319806.SGD","TSYW.SI","LU0823416689.USD","LU0882574055.USD","USJW.SI","LU2362540622.SGD","TQQQ","BK4559","LU0320765992.SGD","BK4139","BK4585","USAW.SI","LU1917777945.USD","NQmain","NVIW.SI","LU2106854487.HKD","LU0058720904.USD","LU2089984988.USD","MNQmain","LU0889565916.HKD","LU0289739699.SGD","QID","LU2362541513.USD","LU2237438978.USD",".IXIC","LU0109394709.USD","LU2362541273.HKD","SQQQ","LU0114720955.EUR"],"gpt_icon":1},{"id":"2518240670","title":"WAINZUA (eplontersen) approved in the EU for the treatment of hereditary transthyretin-mediated amyloidosis in adults with stage 1 or stage 2 polyneuropathy","url":"https://stock-news.laohu8.com/highlight/detail?id=2518240670","media":"Business Wire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2518240670?lang=en_us&edition=fundamental","pubTime":"2025-03-10 19:00","pubTimestamp":1741604400,"startTime":"0","endTime":"0","summary":"– Second major approval for WAINZUA, which is marketed in the U.S. as WAINUA –。– EU approval based on NEURO-TTRansform Phase 3 results showing WAINZUA demonstrated consistent and sustained benefit improving neuropathy impairment and quality of life versus placebo –。CARLSBAD, Calif., March 10, 2025----Ionis Pharmaceuticals, Inc.  announced today that Ionis and AstraZeneca’s WAINZUA  has been approved in the European Union  for the treatment of hereditary transthyretin-mediated amyloidosis in adult patients with stage 1 or stage 2 polyneuropathy, commonly referred to as hATTR-PN or ATTRv-PN. WAINZUA is the only approved medicine in the EU for the treatment of ATTRv-PN that can be self-administered monthly via an auto-injector.ATTR is caused by the accumulation of liver-derived misfolded TTR protein i","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://finance.yahoo.com/news/wainzua-eplontersen-approved-eu-treatment-110000305.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":"yahoofinance","symbols":["BK4201","BK4156","CM","BK4087","IONS","BK4207","CHMP","BK4139","EC","PN"],"gpt_icon":0},{"id":"2517070113","title":"Theriva™ Biologics Reports Full-Year 2024 Operational Highlights and Financial Results","url":"https://stock-news.laohu8.com/highlight/detail?id=2517070113","media":"GlobeNewswire","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517070113?lang=en_us&edition=fundamental","pubTime":"2025-03-07 05:10","pubTimestamp":1741295400,"startTime":"0","endTime":"0","summary":"– Enrollment completed in VIRAGE Phase 2b clinical trial of VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC); topline data expected in Q2 2025 – – VCN-01 development bolstered by FDA award","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/2025/03/06/3038631/0/en/Theriva-Biologics-Reports-Full-Year-2024-Operational-Highlights-and-Financial-Results.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4087","CHMP","DSMC"],"gpt_icon":0},{"id":"2517960965","title":"Bavarian Nordic Publishes Annual Report 2024","url":"https://stock-news.laohu8.com/highlight/detail?id=2517960965","media":"GlobeNewswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517960965?lang=en_us&edition=fundamental","pubTime":"2025-03-05 14:50","pubTimestamp":1741157400,"startTime":"0","endTime":"0","summary":"Audited results confirm full-year revenue of DKK 5,716 million and EBITDA of DKK 1,603 million.Two new early-stage pipeline programs, Lyme disease and Epstein-Barr Virus , introduced.COPENHAGEN, Denmark, March 5, 2025 – Bavarian Nordic A/S  today published its Annual Report for 2024. The consolidated, audited results were in line with the preliminary results announced on February 3, 2025. The full report is attached as a PDF file and can be found on the Company's website, www.bavarian-nordic.com.In February, the U.S. Food and Drug Administration  approved VIMKUNYA, the first virus-like particle single-dose chikungunya vaccine in the US for persons 12 years of age and older. Upon approval, Bavarian Nordic received a Priority Review Voucher, which the Company intends to monetize when appropriate.Bavarian Nordic reported DKK 5,716 million in revenue in 2024, within the range of the latest guidance of DKK 5,400-5,800 million. The revenue was comprised of DKK 3,206 million from Public Prepa","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://finance.yahoo.com/news/bavarian-nordic-publishes-annual-report-065000248.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":"yahoofinance","symbols":["BK4139","CHMP","BK4087","BVNKF","BVNRY"],"gpt_icon":0},{"id":"2516944666","title":"Regeneron Gets Positive CHMP Opinion for Multiple Myeloma Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2516944666","media":"Zacks","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516944666?lang=en_us&edition=fundamental","pubTime":"2025-03-04 04:00","pubTimestamp":1741032000,"startTime":"0","endTime":"0","summary":"Regeneron Pharmaceuticals, Inc. REGN obtained positive opinion for its pipeline candidate linvoseltamab from the European Medicines Agency’s  Committee for Medicinal Products for Human Use .The CHMP recommended conditional marketing authorization of linvoseltamab to treat adults with relapsed and refractory (R/R) multiple myeloma . The recommendation is specific to those who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.A final decision is expected in the coming months.Regeneron’s shares have lost 30.5% in the past year compared with the medical-biomedical genetics industry’s decline of 6.7%.Regeneron Pharmaceuticals Stock Price, Consensus and EPS Surprise. Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote. REGN’s oncology franchise got a boost with the European Commission","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://finance.yahoo.com/news/regeneron-gets-positive-chmp-opinion-200000419.html","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":"yahoofinance","symbols":["LU1066051498.USD","BK4532","RHHBY","BK4087","LU2106854487.HKD","LU1974910355.USD","CHMP","LU1917777945.USD","IE00BKVL7J92.USD","LU1839511570.USD","LU1430594728.SGD","BK4585","LU1585245621.USD","LU0109394709.USD","LU2089984988.USD","LU2362541513.USD","LU2468319806.SGD","IE00BZ1G4Q59.USD","BK4139","IE00B19Z3B42.SGD","BK4007","IE00B7SZLL34.SGD","REGN","IE00B19Z3581.USD","LU2087621335.USD","BK4550","IE0002270589.USD","LU0053666078.USD","LU0320765992.SGD","LU1066053197.SGD","BK4566","BMRN","LU2237438978.USD","LU0234570918.USD","BK4094","LU0882574055.USD","LU0114720955.EUR","LU0823416689.USD","IE00BSNM7G36.USD","LU0289739699.SGD","BK4568","FL","BK4583","03165","LU2023250504.SGD","GILD","LU2362540622.SGD","LU0889565916.HKD","IE00B3T34201.USD","LU0058720904.USD"],"gpt_icon":0},{"id":"2516656745","title":"KRYS Gets Positive CHMP Opinion for EU Approval of Skin Disease Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2516656745","media":"Zacks","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516656745?lang=en_us&edition=fundamental","pubTime":"2025-03-03 23:59","pubTimestamp":1741017540,"startTime":"0","endTime":"0","summary":"Krystal BiotechKRYS announced that the European Medicines Agency'sCommittee for Medicinal Products for Human Use  has adopted a positive opinion recommending the approval of Vyjuvek for the treatment of wounds in patients with dystrophic epidermolysis bullosa . The intended DEB patient population includes those who have mutations in the COL7A1 gene starting from birth.DEB is a rare and severe monogenic disease that affects the skin and mucosal tissues. It is caused by one or more mutations in a gene called COL7A1. Vyjuvekis a non-invasive, topical, redosable gene therapy designed to deliver two copies of theCOL7A1 gene when applied directly to DEB wounds.In the past three months, shares of Krystal Biotech have plunged 18.3% compared with the industry’s 0.6% decline.More on CHMP’s Positive Opinion on Vyjuvek’s EU Approval. The positive CHMP opinion recommending the approval of Vyjuvekfor the DEB indication in the EU is based on the results of Krystal Biotech’s phase I/II GEM-1 and phase","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://finance.yahoo.com/news/krys-gets-positive-chmp-opinion-155900015.html","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":"yahoofinance","symbols":["LU2065170008.USD","IE00BZ1G4Q59.USD","LU2065169927.USD","LU0058720904.USD","IE0002270589.USD","IE00B19Z3581.USD","LU0109394709.USD","LU0289739699.SGD","CHMP","IE00B19Z3B42.SGD","BK4550","BK4588","KRYS","LU0234570918.USD","LU1430594728.SGD","LU1066053197.SGD","LU2065171402.SGD","LU2468319806.SGD","LU0320765992.SGD","BK4583","BK4585","LU2087621335.USD","LU1571399168.USD","IE00B7SZLL34.SGD","IE00B3T34201.USD","BK4087","IE00BSNM7G36.USD","LU1585245621.USD","BMRN","LU2065171311.SGD","BK4156","BK4566","LU1839511570.USD","LU0889565916.HKD","BK4139","BK4578","BK4532","FOLD","LU1066051498.USD","GILD","IE00BKVL7J92.USD","BK4568","LU2089984988.USD"],"gpt_icon":0}],"pageSize":20,"totalPage":7,"pageCount":1,"totalSize":126,"code":"91000000","status":"200"}],"@#url:\"https://hq.skytigris.cn/fundamental/corporate_actions/details/CHMP\",params:#limit:5,,,undefined,":[],"@#url:\"https://hq.skytigris.cn/fundamental/dividend/history\",params:#symbol:\"CHMP\",market:\"US\",,,undefined,":[],"@#url:\"https://hq.skytigris.cn/fundamental/estimate/recommendation\",params:#symbol:\"CHMP\",market:\"US\",delay:false,,,undefined,":{}}}