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89Bio, Inc.

9.62

-0.4200-4.18%

Volume:4.55M

Turnover:44.03M

Market Cap:1.40B

PE:-2.92

High:9.99

Open:9.88

Low:9.46

Close:10.04

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Overview Company News Filings

BRIEF-89Bio Announces Inducement Grants Under Nasdaq Listing Rule

89Bio Inc. Announces New Stock Option Inducement Grants for Employees Under 2023 Inducement Plan

89Bio Inc. Concluded Their Annual Stockholders Meeting

89bio price target lowered to $30 from $31 at BofA

89Bio Inc : Bofa Global Research Cuts Price Objective to $30 From $31

THOMSON REUTERS

89Bio Announces Inducement Grants Under Nasdaq Listing Rule 5635(C)(4)

THOMSON REUTERS

89bio Q1 EPS $(0.49) Beats $(0.50) Estimate

BRIEF-89bio Q1 Net Income USD -71.275 Million Vs. IBES Estimate USD -73.6 Million

89Bio Reports First Quarter 2025 Financial Results and Corporate Updates

THOMSON REUTERS

89Bio Inc - Phase 3 Entrust Trial Fully Enrolled, Topline Data Expected in 1Q 2026

THOMSON REUTERS

Press Release: 89bio Reports First Quarter 2025 Financial Results and Corporate Updates

Why Vertiv Holdings Shares Are Trading Higher By 17%; Here Are 20 Stocks Moving Premarket

Vaxcyte Stock Plummets 56% in a Month: Here's the Reason

VRTX Secures Nod for Expanded Use of CF Drug Kaftrio in Europe

FDA Grants Three Fast Track Tags to Allogene's Autoimmune Disease Drug

BMRN's PKU Drug Palynziq Meets Goal in Late-Stage Pediatric Study

LXRX Stock Moves Up 30% in a Week: What is Driving This Rally?

FDA Accepts Merck's Filing for Subcutaneous Version of Keytruda

FDA Accepts Sanofi's Filing for Multiple Sclerosis Drug Tolebrutinib

Elevation Oncology Plunges 42% on Ending Development of Lead Drug

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Announces New Stock Option Inducement Grants for Employees Under 2023 Inducement Plan","url":"https://stock-news.laohu8.com/highlight/detail?id=2541898971","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2541898971?lang=en_us&edition=fundamental","pubTime":"2025-06-07 04:05","pubTimestamp":1749240318,"startTime":"0","endTime":"0","summary":"San Francisco, June 06, 2025 - 89bio, Inc. , a clinical-stage biopharmaceutical company, has announced the approval of non-qualified stock options for three new employees. This decision, made by the Compensation Committee of the Company's Board of Directors, involves the issuance of options to purchase a total of 61,100 shares of 89bio's common stock. These inducement grants, effective June 3, 2025, are part of the 2023 Inducement Plan and align with Nasdaq Listing Rule 5635. 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IBES Estimate USD -73.6 Million","url":"https://stock-news.laohu8.com/highlight/detail?id=2532887754","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2532887754?lang=en_us&edition=fundamental","pubTime":"2025-05-02 04:05","pubTimestamp":1746129945,"startTime":"0","endTime":"0","summary":"May 01  - 89bio Q1 operating income USD -75.909 million vs. IBES estimate USD -77 million.Q1 pretax profit USD -71.138 million vs. IBES estimate USD -78.8 million","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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250501:nPLXBE62B3:1","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":["BK4139","BK4585","ETNB"],"gpt_icon":0},{"id":"2532887501","title":"89Bio Reports First Quarter 2025 Financial Results and Corporate Updates","url":"https://stock-news.laohu8.com/highlight/detail?id=2532887501","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2532887501?lang=en_us&edition=fundamental","pubTime":"2025-05-02 04:05","pubTimestamp":1746129902,"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:20250501:nTUA8NZP4C: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":["BK4585","BK4139","ETNB"],"gpt_icon":0},{"id":"2532880538","title":"89Bio Inc - Phase 3 Entrust Trial Fully Enrolled, Topline Data Expected in 1Q 2026","url":"https://stock-news.laohu8.com/highlight/detail?id=2532880538","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2532880538?lang=en_us&edition=fundamental","pubTime":"2025-05-02 04:05","pubTimestamp":1746129900,"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:20250501:nPLXBE62B3:6","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","BK4585","ETNB"],"gpt_icon":0},{"id":"2532887217","title":"Press Release: 89bio Reports First Quarter 2025 Financial Results and Corporate Updates","url":"https://stock-news.laohu8.com/highlight/detail?id=2532887217","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2532887217?lang=en_us&edition=fundamental","pubTime":"2025-05-02 04:05","pubTimestamp":1746129900,"startTime":"0","endTime":"0","summary":"-- Topline histology data from ENLIGHTEN-Fibrosis and ENLIGHTEN-Cirrhosis Phase 3 trials are expected in 1H 2027 and in 2028, respectively; each trial is designed to support accelerated approval to treat patients with metabolic dysfunction-associated steatohepatitis  --. -- Cash, cash equivalents, and marketable securities totaled $638.8 million as of March 31, 2025; completed follow-on equity offering in 1Q 2025 with gross proceeds of $287.5 million --. SAN FRANCISCO, May 01, 2025  -- 89bio, Inc. , a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today reported its financial results for the first quarter ended March 31, 2025, and provided corporate updates.","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":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["ETNB","BK4139","BK4585"],"gpt_icon":0},{"id":"2529050530","title":"Why Vertiv Holdings Shares Are Trading Higher By 17%; Here Are 20 Stocks Moving Premarket","url":"https://stock-news.laohu8.com/highlight/detail?id=2529050530","media":"Benzinga","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2529050530?lang=en_us&edition=fundamental","pubTime":"2025-04-23 19:01","pubTimestamp":1745406097,"startTime":"0","endTime":"0","summary":" ","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://www.benzinga.com/25/04/44945232/why-vertiv-holdings-shares-are-trading-higher-by-17-here-are-20-stocks-moving-premarket","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":["ENPH","MRIN","NDRA","AGMH","BGI","BK4147","NG","TSYW.SI","FRGE","BK4588","PSQ","LU0823414478.USD","BK4519","LU2357305700.SGD","TQQQ","LU1093756325.SGD","BK4094","JYD","IE00BN0W2T93.GBP","VRT","IE00BMPRXR70.SGD","SNOA","LU1548497426.USD","BCTX","BK4139","MNQmain","LU2506951792.HKD","NVIW.SI","USJW.SI","BK4082","BK4212","AGRI","USAW.SI","PEGA","QLD","BK4118","ETNB","BK4543","SEDG","SQQQ","BTOG","GAIA","BK4112","QID","NTHI","NQmain",".IXIC"],"gpt_icon":1},{"id":"2526543593","title":"Vaxcyte Stock Plummets 56% in a Month: Here's the Reason","url":"https://stock-news.laohu8.com/highlight/detail?id=2526543593","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2526543593?lang=en_us&edition=fundamental","pubTime":"2025-04-11 01:07","pubTimestamp":1744304820,"startTime":"0","endTime":"0","summary":"Vaxcyte PCVX is a clinical-stage biotech focused on developing vaccines to prevent or treat bacterial infectious diseases.In the past month, PCVX's shares have nosedived 56%. This downside came after Vaxcyte reported mixed results from a phase II study on its investigational pneumococcal conjugate vaccine  in healthy infants.Adding to this headwind, the broader biotech/drug sector is feeling the pressure from the resignation of a senior FDA official instrumental in driving biotech innovation, which has raised alarms around the agency’s ability to maintain momentum on innovation and regulatory clarity.Vaxcyte’s shares have plummeted more than 62% year to date compared with the industry’s 8% decline, as seen in the chart below. During this timeframe, the stock has also underperformed the broader Medical sector and the S&P 500 Index. The company’s shares are also trading below its 50 and 200-day moving averages.Vaxcyte intends to report full post-dose 4 booster data for VAX-24 by the end ","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/vaxcyte-stock-plummets-56-month-170700030.html","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":"yahoofinance","symbols":["BK4588","LU1894683348.USD","SG9999002232.USD","BK4550","PFE","LU0985481810.HKD","IE00B19Z3B42.SGD","LU0289739699.SGD","SG9999013999.USD","LU0566484027.USD","LU0225284248.USD","LU0170899867.USD","ANIP","SGXZ57979304.SGD","LU0306807586.USD","IE00B19Z3581.USD","IE00BLSP4239.USD","BK4139","LU0053671581.USD","LU0321505868.SGD","ETNB","BK4007","BK4534","BK4592","LU0122379950.USD","IE000M9KFDE8.USD","LU1559883803.SGD","LU0234572021.USD","LU1023059063.AUD","LU0306806265.USD","LU0456855351.SGD","PCVX","SG9999001176.SGD","IE0009354923.USD","LU1066053197.SGD","BK4599","LU1057294990.SGD","BK4585","LU0225771236.USD","LU0058720904.USD","LU0868494617.USD","LU1883839398.USD","SG9999011175.SGD","BK4533","IE00BLSP4452.SGD","BK4581","LU1066051498.USD","IE0002270589.USD","BK4568"],"gpt_icon":1},{"id":"2525437894","title":"VRTX Secures Nod for Expanded Use of CF Drug Kaftrio in Europe","url":"https://stock-news.laohu8.com/highlight/detail?id=2525437894","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2525437894?lang=en_us&edition=fundamental","pubTime":"2025-04-08 18:55","pubTimestamp":1744109700,"startTime":"0","endTime":"0","summary":"Vertex Pharmaceuticals VRTX announced that the European Commission  has expanded the label of its blockbuster cystic fibrosis  drug, Kaftrio, to treat all patients aged two years and older who have at least one non-class I mutation in the CFTR gene.This approval was expected as the EMA’s Committee for Medicinal Products for Human Use  issued a positive opinion recommending Kaftrio’s approval in February for the above indication. With this expanded label, nearly 4,000 more CF patients living in the region are now eligible for treatment with the drug.Kaftrio is already approved for use in CF patients aged two years and older who have at least one F508del mutation in the CFTR gene.The drug is marketed by Vertex for similar indications in the United States under the trade name Trikafta.Year to date, shares of Vertex have gained 18% against the industry’s 7% decline.Estimates for 89bio’s loss per share have narrowed from $2.51 to $1.98 for 2025 in the","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/vrtx-secures-nod-expanded-cf-105500149.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":["LU2324357040.USD","BK4567","LU1035775433.USD","IE00B19Z9P08.USD","LU0417517546.SGD","BK4093","IE00BFTCPJ56.SGD","LU0823416689.USD","BK4007","BK4023","LU1093756168.USD","SG9999013999.USD","BK4568","IE00BJJMRZ35.SGD","ANIP","BK4588","VERX","SG9999001176.USD","LU0320765992.SGD","EC","BK4201","BK4139","LU1559883803.SGD","IE00B894F039.SGD","LU0757428866.USD","IE00BZ9MQY76.HKD","LU2462157665.USD","LU1585245621.USD","LU2417539215.USD","IE0002141913.USD","SG9999001176.SGD","VRTX","BK4533","BK4551","LU0109394709.USD","IE00BJT1NW94.SGD","LU2236285917.USD","SGXZ57979304.SGD","LU1430594728.SGD","LU2362540622.SGD","CF","IE0002270589.USD","LU2237438978.USD","IE00B19Z3B42.SGD","LU2456880835.USD","LU0289739699.SGD","ETNB","LU2362541273.HKD"],"gpt_icon":1},{"id":"2525318890","title":"FDA Grants Three Fast Track Tags to Allogene's Autoimmune Disease Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2525318890","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2525318890?lang=en_us&edition=fundamental","pubTime":"2025-04-08 18:46","pubTimestamp":1744109160,"startTime":"0","endTime":"0","summary":"Allogene Therapeutics ALLO announced that the FDA has granted three fast track designations to its investigational CRISPR-based allogeneic CAR-T therapy, ALLO-329.These designations apply to three autoimmune diseases — systemic lupus erythematosus , idiopathic inflammatory myopathy  and diffuse systemic sclerosis .How Does the Fast Track Tag Benefit ALLO’s Drug Development?Fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions, meet an unmet medical need, or offer a potential advantage over existing treatments. Per the FDA, the purpose of granting this designation is to ‘get important new drugs to the patient earlier.’。In the past 60 days, estimates for CytomX Therapeutics’ 2025 EPS have improved from a loss of 31 cents to a profit of 25 cents. During the same timeframe, estimates for loss per share for 2026 have","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/fda-grants-three-fast-track-104600523.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":["FAST","BK4007","ETNB","CTMX","BK4588","BK4505","ANIP","ALLO","BK4104","BK4139","IE00BFXG0V08.USD","IIM","SLE","IE00BYQQ9H92.USD","IE00B5TLWC47.USD","BK4077","BK4585","BK4567"],"gpt_icon":0},{"id":"2524260088","title":"BMRN's PKU Drug Palynziq Meets Goal in Late-Stage Pediatric Study","url":"https://stock-news.laohu8.com/highlight/detail?id=2524260088","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524260088?lang=en_us&edition=fundamental","pubTime":"2025-04-03 22:14","pubTimestamp":1743689640,"startTime":"0","endTime":"0","summary":"BioMarin BMRN has announced positive results from the phase III PEGASUS study evaluating Palynziq  in adolescents aged 12-17 years with phenylketonuria .The study achieved its primary endpoint – patients treated with Palynziq achieved a statistically significant lowering in blood phenylalanine  levels compared to diet alone. The safety results were also consistent with the known profile of the drug.Palynziq is already approved in the United States to reduce blood Phe concentration in adults aged 18 years and older with PKU. The drug is currently the only enzyme therapy to treat the disease in this age group.PKU is a rare genetic disorder that prevents the body from breaking down Phe, an amino acid found in protein-rich foods, leading to toxic levels that can cause severe neurological damage. While newborn screening enables early diagnosis, lifelong dietary management is challenging, creating demand for innovative treatments like those developed by BioMarin.In the past 60 days, estimate","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/bmrns-pku-drug-palynziq-meets-141400981.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":["IE0002270589.USD","SSI","IE00B7SZLL34.SGD","BK4007","BK4139","ANIP","CTMX","IE00B19Z3B42.SGD","IE00B19Z3581.USD","BK4566","ETNB","BK4585","BMRN"],"gpt_icon":0},{"id":"2524460415","title":"LXRX Stock Moves Up 30% in a Week: What is Driving This Rally?","url":"https://stock-news.laohu8.com/highlight/detail?id=2524460415","media":"Zacks","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524460415?lang=en_us&edition=fundamental","pubTime":"2025-04-02 22:18","pubTimestamp":1743603480,"startTime":"0","endTime":"0","summary":"Shares of Lexicon Pharmaceuticals LXRX have jumped 30% after signing a licensing deal for its pre-clinical obesity drug LX9851 with pharma giant Novo Nordisk NVO last week.Per the deal terms, Lexicon will complete certain preclinical activities before Novo Nordisk takes over the development, manufacturing and commercialization of LX9851. NVO will also be responsible for LX9851’s investigational new drug  filing.In return, LXRX is eligible to receive $75 million as an upfront payment from NVO. Including milestone payments, the deal is worth up to $1 billion. Lexicon will also earn tiered royalties on potential net sales of the drug.Post the above setback, LXRX decided to discontinue developing the drug for the T1D indication and announced plans to reduce its workforce by 60%.A couple of better-ranked stocks from the sector are ANI Pharmaceuticals ANIP and 89bio ETNB. ANIP sports a Zacks Rank #1  at present and ETNB carries a Zacks Rank #2","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/lxrx-stock-moves-30-week-141800883.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":["LU1093756168.USD","BK4007","ETNB","BK4588","IE00BZ1G4Q59.USD","ANIP","BK4139","LU0154236417.USD","LXRX","BK4599","BK4532","NVO","BK4585","LU1093756325.SGD","IE00BKVL7J92.USD"],"gpt_icon":1},{"id":"2523685649","title":"FDA Accepts Merck's Filing for Subcutaneous Version of Keytruda","url":"https://stock-news.laohu8.com/highlight/detail?id=2523685649","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2523685649?lang=en_us&edition=fundamental","pubTime":"2025-03-28 23:20","pubTimestamp":1743175200,"startTime":"0","endTime":"0","summary":"Merck MRK announced that the FDA has accepted its regulatory filing seeking approval for the subcutaneous  formulation of the blockbuster drug Keytruda .This filing seeks the agency’s nod for the SC version across all solid tumor indications for which the drug’s intravenous  version is already approved.A final decision is expected by Sept. 23, 2025.The regulatory filing is supported by data from the pivotal phase III 3475A-D77 study that evaluated Keytruda SC against the IV version  for the first-line treatment of adult patients with metastatic non-small cell lung cancer. As announced by Merck in November, the study achieved its primary endpoints, showing that the treatment with the SC version of the drug was at least as effective as the IV version.An approval of the SC version also benefits both patients and physicians. Delivering a drug SC instead of IV can significantly reduce administrat","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/fda-accepts-mercks-filing-subcutaneous-152000184.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":["LU1066051811.HKD","IE000M9KFDE8.USD","IE00BN8TJ469.HKD","SG9999014575.USD","CTMX","IE00BSNM7G36.USD","IE00BLSP4239.USD","LU1023059063.AUD","LU1037948897.HKD","LU1983299246.USD","ETNB","SG9999001176.SGD","IE00BJT1NW94.SGD","LU1585245621.USD","LU1941712264.USD","LU0320765646.SGD","LU0965509283.SGD","BK4139","IE00BJJMRZ35.SGD","LU0985320562.USD","MRK","LU1989772840.SGD","LU0058720904.USD","LU1066053197.SGD","BK4585","LU1989772923.USD","BK4516","LU2023250843.SGD","SG9999002224.SGD","LU0266013472.USD","ANIP","LU1066051498.USD","BK4550","LU0070302665.USD","LU0965509010.AUD","LU1037948541.HKD","LU0208291251.USD","LU1116320737.USD","IE0002141913.USD","LU1093756325.SGD","LU1934455863.HKD","LU0289739699.SGD","SG9999015358.SGD","LU2361044865.SGD","SG9999015341.SGD","LU0861579265.USD","LU0320765489.SGD","LU2112291526.USD","IE00B4R5TH58.HKD"],"gpt_icon":0},{"id":"2522079582","title":"FDA Accepts Sanofi's Filing for Multiple Sclerosis Drug Tolebrutinib","url":"https://stock-news.laohu8.com/highlight/detail?id=2522079582","media":"Zacks","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2522079582?lang=en_us&edition=fundamental","pubTime":"2025-03-25 19:56","pubTimestamp":1742903760,"startTime":"0","endTime":"0","summary":"Sanofi SNY announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis  and slow disability accumulation independent of relapse activity in adults.The filing has been granted priority review by the FDA, bringing down the review period by four months. A final decision is expected by Sept. 28, 2025.The FDA filing is supported by data from three late-stage studies — one  in nrSPMS and two  in relapsing MS . Data from these studies showed that patients treated with tolebrutinib delayed the time to onset of six-month confirmed disability progression when compared to placebo. A similar regulatory filing for the drug is currently under review by the EMA, which is also supported by data from these studies.Per Sanofi, the above results make tolebrutinib the first and the only brain-penetrant BTK inhibitor to treat both the above MS indications. If approved, tolebruti","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/fda-accepts-sanofis-filing-multiple-115600487.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":["BK4534","LU0098860793.USD","LU1162221912.USD","LU2028103732.USD","LU0971096721.USD","LU1363072403.SGD","LU0314104364.USD","LU2111349929.HKD","LU1548497426.USD","BK4581","IE00BZ1G4Q59.USD","LU1989772840.SGD","LU0106831901.USD","IE0031619046.USD","LU1732799900.SGD","LU2357305700.SGD","MG","LU1074936037.SGD","BK4123","IE00B66KJ199.SGD","LU0158827781.USD","IE00B19Z4B17.USD","IE00BKVL7J92.USD","LU2089283258.USD","LU2023251221.USD","LU0225283273.USD","BK4516","BK4504","ANIP","IE00BFXG1179.USD","CTMX","LU0795875169.SGD","SNY","LU1668664300.SGD","LU0912757837.SGD","BK4585","SNYNF","LU1720051108.HKD","BK4139","LU0320765646.SGD","LU0158827948.USD","LU1732800096.USD","LU1720051017.SGD","ETNB","LU0106261372.USD","LU0267386448.USD","BK4588","LU2271345857.HKD","LU2133065610.SGD"],"gpt_icon":0},{"id":"2521940256","title":"Elevation Oncology Plunges 42% on Ending Development of Lead Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2521940256","media":"Zacks","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2521940256?lang=en_us&edition=fundamental","pubTime":"2025-03-22 01:03","pubTimestamp":1742576580,"startTime":"0","endTime":"0","summary":"Shares of Elevation Oncology ELEV plunged more than 40% yesterday after reporting disappointing data from a phase I study on its lead pipeline drug EO-3021 for treating advanced, unresectable or metastatic gastric and gastroesophageal junction  cancers.Data from the study showed that patients who were treated with ELEV’s lead drug showed an objective response rate  of 22.2% —out of 36 evaluable patients, there was one complete response and seven partial responses.Following the disappointing study results, Elevation Oncology decided not to pursue further clinical development of EO-3021. Instead, the company will now shift its focus to solid tumor candidate EO-1022, for which an investigational new drug  filing with the FDA is expected next year. As a result of this decision, ELEV is now without a pipeline candidate in clinical development. These factors were likely responsible for the significant drop in share price.In the past 60 days, estimates for CytomX Therapeutics’ 2025 EPS have 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