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Urogen Pharma Ltd.

7.37

+2.2343.39%

Post-market: 7.640.2700+3.66%19:59 EDT

Volume:20.72M

Turnover:150.50M

Market Cap:339.81M

PE:-2.42

High:8.25

Open:5.33

Low:5.23

Close:5.14

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Overview Company News Filings

UroGen Pharma Ltd. Announces Inducement Grants of Restricted Stock Units to New Employees

Urogen Pharma Ltd : Oppenheimer Cuts Target Price to $10 From $36

THOMSON REUTERS

Oppenheimer Remains a Buy on Urogen Pharma (URGN)

UroGen Pharma Is Maintained at Buy by Guggenheim

Urogen Pharma Ltd : Guggenheim Cuts Target Price to $15 From $40

THOMSON REUTERS

UroGen Pharma Shares Fall After HC Wainwright Downgrade

MT Newswires Live

UroGen Pharma Is Maintained at Neutral by Goldman Sachs

UroGen's FDA Stumble Connected to Trial Concerns -- Market Talk

BUZZ-UroGen Pharma falls as FDA panel narrowly votes against bladder cancer drug

HC Wainwright Downgrades UroGen Pharma to Neutral From Buy

MT Newswires Live

UroGen Pharma Cut to Neutral From Buy by HC Wainwright & Co.

Sector Update: Health Care Stocks Slide Wednesday Afternoon

MT Newswires Live

UroGen Pharma Shares Fall After US FDA Committee Vote on Bladder Cancer Drug

MT Newswires Live

UroGen Pharma down over 50% after resuming trading

UroGen Pharma announces outcome of ODAC meeting for UGN-102

UroGen Pharma Awaits FDA Decision on UGN-102 for Recurrent Bladder Cancer, Following Narrow ODAC Vote

Scotiabank Keeps Their Buy Rating on Urogen Pharma (URGN)

UroGen Falls to 52-Week Low, FDA Document Indicates Cancer Drug Study Disagreement

UroGen Pharma down after FDA posts UGN-102 briefing documents

TD remains confident in approval after UroGen briefing docs

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Announces Inducement Grants of Restricted Stock Units to New Employees","url":"https://stock-news.laohu8.com/highlight/detail?id=2541426852","media":"Reuters","labels":["executive"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2541426852?lang=en_us&edition=fundamental","pubTime":"2025-06-06 20:00","pubTimestamp":1749211220,"startTime":"0","endTime":"0","summary":"PRINCETON, N.J.---- UroGen Pharma Ltd. , a biotech company focused on innovative treatments for urothelial and specialty cancers, has announced the issuance of inducement restricted stock units  to 27 newly hired employees. These grants are part of the company's 2019 Inducement Plan and are aligned with Nasdaq Listing Rule 5635, serving as a material inducement for employment with UroGen. The RSUs involve up to 118,000 ordinary shares, which will vest equally over a three-year period, contingent upon the employees' continued service with the company. This initiative is linked to the ongoing commercialization efforts for Jelmyto and the advancement of UroGen's product pipeline.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Urogen Pharm","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:20250606:nNDLYBFtt:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"executive","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["URGN","BK4139"],"gpt_icon":0},{"id":"2540771873","title":"Urogen Pharma Ltd : Oppenheimer Cuts Target Price to $10 From $36","url":"https://stock-news.laohu8.com/highlight/detail?id=2540771873","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2540771873?lang=en_us&edition=fundamental","pubTime":"2025-06-03 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released today, Leland Gershell from Oppenheimer reiterated a Buy rating on Urogen Pharma (URGN – Research Report), with a price target...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/oppenheimer-remains-a-buy-on-urogen-pharma-urgn-2?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/blurbs/oppenheimer-remains-a-buy-on-urogen-pharma-urgn-2?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":["OPY","BK4127","URGN","BK4139"],"gpt_icon":0},{"id":"2537130297","title":"UroGen Pharma Is Maintained at Buy by Guggenheim","url":"https://stock-news.laohu8.com/highlight/detail?id=2537130297","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537130297?lang=en_us&edition=fundamental","pubTime":"2025-05-23 22:55","pubTimestamp":1748012100,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/URGN/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  May 23, 2025 10:55 ET (14:55 GMT)","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"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":["URGN"],"gpt_icon":0},{"id":"2537133822","title":"Urogen Pharma Ltd : Guggenheim Cuts Target Price to $15 From $40","url":"https://stock-news.laohu8.com/highlight/detail?id=2537133822","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537133822?lang=en_us&edition=fundamental","pubTime":"2025-05-23 19:02","pubTimestamp":1747998178,"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:20250523:nFWN3RV1GH: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":["URGN","BK4139"],"gpt_icon":0},{"id":"2537929734","title":"UroGen Pharma Shares Fall After HC Wainwright Downgrade","url":"https://stock-news.laohu8.com/highlight/detail?id=2537929734","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537929734?lang=en_us&edition=fundamental","pubTime":"2025-05-23 02:20","pubTimestamp":1747938035,"startTime":"0","endTime":"0","summary":"UroGen Pharma's (URGN) shares fell 6% in recent Thursday trading after HC Wainwright downgraded the stock to neutral from buy.Intraday volume topped 2.53 million shares versus the daily average of 939,720.Price: 3.92, Change: -0.25, Percent Change: -6.00","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"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":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["URGN"],"gpt_icon":0},{"id":"2537947227","title":"UroGen Pharma Is Maintained at Neutral by Goldman Sachs","url":"https://stock-news.laohu8.com/highlight/detail?id=2537947227","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537947227?lang=en_us&edition=fundamental","pubTime":"2025-05-22 22:35","pubTimestamp":1747924500,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/URGN/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  May 22, 2025 10:35 ET (14:35 GMT)","market":"hk","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"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":["URGN"],"gpt_icon":0},{"id":"2537995941","title":"UroGen's FDA Stumble Connected to Trial Concerns -- Market Talk","url":"https://stock-news.laohu8.com/highlight/detail?id=2537995941","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537995941?lang=en_us&edition=fundamental","pubTime":"2025-05-22 21:14","pubTimestamp":1747919640,"startTime":"0","endTime":"0","summary":"0914 ET - An FDA advisory committee raised concerns about clinical trial design before narrowly voting no on whether the benefits of UroGen Pharma's UGN-102 outweighed its risks in treating recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer. A key factor was the single-arm design of the Phase 3 trail of UGN-102, which lacked a concurrent control arm, D. Boral analyst Jason Kolbert says in a research note. The FDA isn't bound by the committee's recommendation and will continue its review, Kolbert says. Based on the meeting dialogue and the data package that UroGen submitted, the chances of FDA approval for UGN-102 are actually better than the market seems to be indicating with recent share declines, Oppenheimer analysts say in a note. ","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":"-1","news_top_title":"UroGen's FDA Stumble Connected to Trial Concerns -- Market Talk","news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","URGN"],"gpt_icon":0},{"id":"2537194969","title":"BUZZ-UroGen Pharma falls as FDA panel narrowly votes against bladder cancer drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2537194969","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537194969?lang=en_us&edition=fundamental","pubTime":"2025-05-22 20:47","pubTimestamp":1747918022,"startTime":"0","endTime":"0","summary":"BUZZ-UroGen Pharma falls as FDA panel narrowly votes against bladder cancer drug ** U.S.-listed shares of biopharma firm UroGen Pharma UR8.F, URGN.O fall 3.4% to $4.03 premarket** URGN said on Tuesday that U.S. FDA advisers narrowly voted against its experimental drug for a type of bladder cancer** The drug, UGN-102, is under review for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer** \"While we are disappointed by  outcome, we continue to believe our clinical data support UGN-102 for the treatment of recurrent LG-IR-NMIBC, a disease with no FDA-approved therapies,\" said CEO Liz Barrett** Brokerage Oppenheimer says \"the committee expressed concern around the regulatory precedent that might be set should '102 be approved off its current dataset that relies on a single arm study for efficacy\"** FDA to decide on URGN's drug by June 13 ** Oppenheimer says that a lack of randomized comparisons limits assessments of efficacy and safety** As of last close, U.S.","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:20250522:nL4N3RU10B:1","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":["URGN","BK4139"],"gpt_icon":0},{"id":"2537943170","title":"HC Wainwright Downgrades UroGen Pharma to Neutral From Buy","url":"https://stock-news.laohu8.com/highlight/detail?id=2537943170","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537943170?lang=en_us&edition=fundamental","pubTime":"2025-05-22 19:33","pubTimestamp":1747913589,"startTime":"0","endTime":"0","summary":"UroGen Pharma (URGN) has an average rating of overweight and mean price target of $31, according to analysts polled by FactSet.(MT Newswires covers equity, commodity and economic research from major b","market":"sg","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"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":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["URGN"],"gpt_icon":0},{"id":"2537943881","title":"UroGen Pharma Cut to Neutral From Buy by HC Wainwright & Co.","url":"https://stock-news.laohu8.com/highlight/detail?id=2537943881","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537943881?lang=en_us&edition=fundamental","pubTime":"2025-05-22 19:17","pubTimestamp":1747912620,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/URGN/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  May 22, 2025 07:17 ET (11:17 GMT)","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"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":["URGN"],"gpt_icon":0},{"id":"2537539609","title":"Sector Update: Health Care Stocks Slide Wednesday Afternoon","url":"https://stock-news.laohu8.com/highlight/detail?id=2537539609","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537539609?lang=en_us&edition=fundamental","pubTime":"2025-05-22 01:56","pubTimestamp":1747850190,"startTime":"0","endTime":"0","summary":"Health care stocks declined Wednesday afternoon, with the NYSE Health Care Index falling 1% and the Health Care Select Sector SPDR Fund  dropping 1.3%.The iShares Biotechnology ETF  slumped 1.6%.In corporate news, UnitedHealth  allegedly paid thousands of dollars in bonuses to nursing homes where it installed its own medical teams and pressured them to help cut care expenses for residents, The Guardian reported. UnitedHealth shares were falling 5%.UroGen Pharma  shares tumbled 47% after it said its UGN-102 bladder cancer drug failed to receive the backing of a US Food and Drug Administration advisory committee.Akoya Biosciences  shares jumped 25% after it said in a Wednesday filing that it received an unsolicited acquisition proposal from an undisclosed third party, which offered $1.40 in cash for each Akoya common share.","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://www.mtnewswires.com/","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":"mtnewswires_news","symbols":["URGN","LU1934455863.HKD","SGXZ99366536.SGD","UNH","LU0965509101.SGD","LU0738911758.USD","LU1551013342.USD","LU1674673428.USD","LU1035773651.USD","LU1732799900.SGD","LU0553294199.USD","LU0320765059.SGD","LU1551013425.SGD","LU0187121727.USD","LU0289739699.SGD","LU2111349929.HKD","BK4588","LU0094547139.USD","LU2361044865.SGD","LU1084165304.USD","IE00B19Z9P08.USD","BK4532","LU1119994496.HKD","IBB","IE0002270589.USD","IE0002141913.USD","IE00BWXC8680.SGD","LU0661504455.SGD","LU2089984988.USD","LU2125154935.USD","IE00B19Z8W00.USD","LU0077335932.USD","LU0211327993.USD","LU0251132253.USD","LU0545039389.USD","LU2362541513.USD","LU0316494557.USD","LU0211326755.USD","LU0048584097.USD","AKYA","LU2461242641.AUD","LU1066051498.USD","IE00BKVL7J92.USD","SGXZ51526630.SGD","XLV","LU1267930227.SGD","LU2357305700.SGD","LU1323610961.USD","BK4154","LU0345770308.USD"],"gpt_icon":1},{"id":"2537953629","title":"UroGen Pharma Shares Fall After US FDA Committee Vote on Bladder Cancer Drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2537953629","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537953629?lang=en_us&edition=fundamental","pubTime":"2025-05-22 01:51","pubTimestamp":1747849895,"startTime":"0","endTime":"0","summary":"UroGen Pharma  shares tumbled 48% in recent Wednesday trading after the company said its UGN-102 bladder cancer drug failed to receive the backing of a US Food and Drug Administration advisory committee.The new drug application for UGN-102 is currently under review by the FDA with a decision expected on June 13, the company said Wednesday in a statement.\"While we are disappointed by today's outcome, we continue to believe our clinical data support UGN-102 for the treatment of recurrent LG-IR-NMIBC, a disease with no FDA-approved therapies,\" UroGen Pharma Chief Executive Officer Liz Barrett said in the statement.\"The FDA carefully considers the independent advice\" from the Oncologic Drugs Advisory Committee, and \"we look forward to working with the FDA as they complete their review of the application for UGN-102,\" Barrett said.UGN-102, or mitomycin, is designed to treat recurrent low-grade intermediate-risk non-muscle invasive bladder cancer.Price: 3.91, Change: -3.63, Percent Change: -","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":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["URGN","BK4139"],"gpt_icon":0},{"id":"2537958361","title":"UroGen Pharma down over 50% after resuming trading","url":"https://stock-news.laohu8.com/highlight/detail?id=2537958361","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537958361?lang=en_us&edition=fundamental","pubTime":"2025-05-22 01:00","pubTimestamp":1747846828,"startTime":"0","endTime":"0","summary":"Shares of UroGen Pharma (URGN) have resumed trading and are down $3.96, or 52%, to $3.59 after the Oncologic Drugs Advisory Committee of the U.S. F...","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/urogen-pharma-down-over-50-after-resuming-trading?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/urogen-pharma-down-over-50-after-resuming-trading?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","URGN"],"gpt_icon":0},{"id":"2537930463","title":"UroGen Pharma announces outcome of ODAC meeting for UGN-102","url":"https://stock-news.laohu8.com/highlight/detail?id=2537930463","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537930463?lang=en_us&edition=fundamental","pubTime":"2025-05-22 00:25","pubTimestamp":1747844711,"startTime":"0","endTime":"0","summary":"UroGen Pharma (URGN) announced the outcome of the meeting of the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration, which...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/urogen-pharma-announces-outcome-of-odac-meeting-for-ugn-102?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/urogen-pharma-announces-outcome-of-odac-meeting-for-ugn-102?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["URGN","BK4139"],"gpt_icon":0},{"id":"2537377239","title":"UroGen Pharma Awaits FDA Decision on UGN-102 for Recurrent Bladder Cancer, Following Narrow ODAC Vote","url":"https://stock-news.laohu8.com/highlight/detail?id=2537377239","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2537377239?lang=en_us&edition=fundamental","pubTime":"2025-05-22 00:17","pubTimestamp":1747844237,"startTime":"0","endTime":"0","summary":"UroGen Pharma Ltd., a biotech company specializing in treatments for urothelial and specialty cancers, has announced that the Oncologic Drugs Advisory Committee  of the U.S. Food and Drug Administration  has reviewed their new drug application  for UGN-102  for intravesical solution. The committee narrowly voted 4 to 5 against the benefit/risk profile of UGN-102 as favorable for the treatment of recurrent low-grade intermediate-risk non-muscle invasive bladder cancer . Despite this, UroGen remains optimistic about their clinical data and is committed to working with the FDA as the NDA continues under review. The FDA's final decision is expected by June 13, 2025, per the Prescription Drug User Fee Act  timeline.Disclaimer: This news brief was created by Public Technologies  using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, invest","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:20250521:nNDL9GxTMv:1","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":["BK4139","URGN"],"gpt_icon":0},{"id":"2536134611","title":"Scotiabank Keeps Their Buy Rating on Urogen Pharma (URGN)","url":"https://stock-news.laohu8.com/highlight/detail?id=2536134611","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2536134611?lang=en_us&edition=fundamental","pubTime":"2025-05-20 19:16","pubTimestamp":1747739761,"startTime":"0","endTime":"0","summary":"Scotiabank analyst George Farmer reiterated a Buy rating on Urogen Pharma (URGN – Research Report) today and set a price target of $23.00. The comp...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/scotiabank-keeps-their-buy-rating-on-urogen-pharma-urgn?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["rate","earning"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/scotiabank-keeps-their-buy-rating-on-urogen-pharma-urgn?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":["URGN"],"gpt_icon":0},{"id":"2536476342","title":"UroGen Falls to 52-Week Low, FDA Document Indicates Cancer Drug Study Disagreement","url":"https://stock-news.laohu8.com/highlight/detail?id=2536476342","media":"Dow Jones","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2536476342?lang=en_us&edition=fundamental","pubTime":"2025-05-17 03:24","pubTimestamp":1747423440,"startTime":"0","endTime":"0","summary":"UroGen Pharma shares fell to a 52-week low after a Food and Drug Administration document indicated disagreements with the company about certain aspects of studies of bladder cancer drug UGN-102.The stock declined 26% to $7.25 Friday and is down about 31% this year. Its intraday low was $6.46.The FDA posted a briefing document for Wednesday's advisory committee meeting. The agency said that because the Envision trial lacked a concurrent control arm, the primary endpoints of complete response and duration of response are difficult to interpret. The agency said it recommended a randomized trial design several times.UroGen said on April 26 that updated results from a study of UGN-102 for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer \"demonstrated a compelling probability of remaining in complete response of 80.6% at 18 months in patients who achieved a complete response at three months .\". The company has noted that the existing standard of care for LG-IR-NMIBC i","market":"other","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":"UroGen Falls to 52-Week Low, FDA Document Indicates Cancer Drug Study Disagreement","news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["URGN","BK4139"],"gpt_icon":0},{"id":"2536344929","title":"UroGen Pharma down after FDA posts UGN-102 briefing documents","url":"https://stock-news.laohu8.com/highlight/detail?id=2536344929","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2536344929?lang=en_us&edition=fundamental","pubTime":"2025-05-17 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posted...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/urogen-pharma-down-after-fda-posts-ugn-102-briefing-documents?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/urogen-pharma-down-after-fda-posts-ugn-102-briefing-documents?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["URGN","BK4139"],"gpt_icon":0},{"id":"2536344967","title":"TD remains confident in approval after UroGen briefing 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