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Organon & Co

13.68

+0.01500.11%

Volume:316.43K

Turnover:4.32M

Market Cap:3.59B

PE:17.25

High:13.68

Open:13.67

Low:13.66

Close:13.66

52wk High:13.79

52wk Low:5.69

Shares:262.60M

Float Shares:243.00M

Volume Ratio:0.53

T/O Rate:0.13%

Dividend:0.08

Dividend Rate:0.59%

EPS(TTM):0.7929

EPS(LYR):0.7200

ROE:24.04%

ROA:5.67%

PB:3.57

PE(LYR):18.99

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Overview Company News Filings

Press Release: Organon to Report Second Quarter 2026 Results in Its Regularly Scheduled Form 10-Q Filing

Organon to Present New Pooled Phase 3 Analysis of VTAMA in Atopic Dermatitis at 2026 Pediatric Dermatology Meeting

Jefferies Quarterly Profit Misses Estimates as Asset Management Weighs

Jefferies Quarterly Profit More than Doubles on Dealmaking, Equities Strength

Organon, Shanghai Henlius Biotech Launch Denosumab Biosimilars in Canada

MT Newswires Live

Organon Closes Deal to License Sebela Pharmaceuticals' Miudella Intrauterine Device

MT Newswires Live

Organon completes global MIUDELLA copper IUD licensing deal with Sebela

Organon Completes Agreement to License Miudella®, Sebela Pharmaceuticals’ Hormone-Free Intrauterine Device

THOMSON REUTERS

Organon & Co - Miudella Expected to Be Commercially Available in Late 2026

THOMSON REUTERS

Organon and Samsung Bioepis expand commercialization agreement for Pyzchiva

Organon, Samsung Bioepis expand Canada commercialization pact for ustekinumab biosimilar PYZCHIVA

Organon & Co - Pyzchiva Expected to Launch in Canada in 2026

THOMSON REUTERS

Organon & Co - Agreement Expands Biosimilar Collaboration in Canada to Six Products

THOMSON REUTERS

Organon & Co - to Obtain Commercialization Rights to Pyzchiva in Canada

THOMSON REUTERS

Organon and Samsung Bioepis Expand Agreement to Commercialize Pyzchiva® (Ustekinumab), a Biosimilar Referencing Stelara® (Ustekinumab) in Canada

THOMSON REUTERS

Shore Capital Reaffirms Their Buy Rating on Origin Enterprises plc (OGN)

Organon shareholders approve amended 2021 incentive stock plan, adding 8 million shares

Organon wins US approval to widen use of arthritis biosimilar drug

Organon Expands Tofidence Label With FDA Approval for Additional Indications

MT Newswires Live

Organon announces U.S. FDA approval pf sBLA for Tofidence injection

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20:00","pubTimestamp":1783425654,"startTime":"0","endTime":"0","summary":"Organon to present new pooled Phase 3 analysis of VTAMA in atopic dermatitis at 2026 pediatric dermatology meetingOrganon flagged a new post hoc pooled analysis of Phase 3 ADORING 1 and 2 trials for V","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:20260707:nNDL4lCr8j: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":null,"symbols":["BK4588","OGN","BK4559","BK4007","FXH","LU2065171402.SGD","LU2065170008.USD","LU2065171311.SGD","LU2065169927.USD","BK4585"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2646841995","title":"Jefferies Quarterly Profit Misses Estimates as Asset Management Weighs","url":"https://stock-news.laohu8.com/highlight/detail?id=2646841995","media":"Reuters","labels":["shareholding","dataReport","event"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2646841995?lang=en_us&edition=fundamental","pubTime":"2026-06-25 06:09","pubTimestamp":1782338981,"startTime":"0","endTime":"0","summary":"UPDATE 1-Jefferies quarterly profit misses estimates as asset management weighsRecord investment banking revenue, fueled by strong dealmaking and equity underwritingJefferies cited strong backlog and ","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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260624:nL4N42W1S1:3","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"shareholding,dataReport,event","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK0028","BK4585","LU2065169927.USD","BK4559","XE","ARXS","300485","BK0012","BK0239","LU2065170008.USD","BK4588","BK4187","LU2065171311.SGD","JEF","OGN","BK4127","BK4182","LU2065171402.SGD","BK4007","BK0046"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2646909845","title":"Jefferies Quarterly Profit More than Doubles on Dealmaking, Equities Strength","url":"https://stock-news.laohu8.com/highlight/detail?id=2646909845","media":"Reuters","labels":["shareholding"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2646909845?lang=en_us&edition=fundamental","pubTime":"2026-06-25 04:17","pubTimestamp":1782332230,"startTime":"0","endTime":"0","summary":"Jefferies quarterly profit more than doubles on dealmaking, equities strengthJune 24 (Reuters)-Jefferies Financial GroupJEF.Nsaid on Wednesday its profit more than doubled in the second quarter, as 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Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2645838996?lang=en_us&edition=fundamental","pubTime":"2026-06-23 18:57","pubTimestamp":1782212271,"startTime":"0","endTime":"0","summary":"Organon's  Canada unit and Shanghai Henlius Biotech launched Bildyos and Tuzemty injections in Canada, the companies said Tuesday.The products, denosumab biosimilars to Prolia and Xgeva, are approved for all indications of the reference medicines and are used to treat osteoporosis and bone conditions linked to cancer, according to the companies.The launches expand Organon's biosimilar portfolio in Canada and follow a 2022 licensing and supply agreement with Henlius that granted Organon exclusive commercialization rights for the products outside China, the companies said.","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":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4559","LU2065171311.SGD","BK4581","LU2065171402.SGD","LU2065170008.USD","BK4007","BK4585","BK4588","XBI","LU2065169927.USD","OGN"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2645024454","title":"Organon Closes Deal to License Sebela Pharmaceuticals' Miudella Intrauterine Device","url":"https://stock-news.laohu8.com/highlight/detail?id=2645024454","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2645024454?lang=en_us&edition=fundamental","pubTime":"2026-06-22 20:04","pubTimestamp":1782129857,"startTime":"0","endTime":"0","summary":"Organon  said Monday it has completed a global licensing deal with Sebela Pharmaceuticals that gives it exclusive rights to Miudella, a hormone-free, copper intrauterine device.Under the terms of the agreement, which were announced in February, Organon was to pay $27.5 million at closing, with potential sales-based milestone payments of up to $505 million, as well as tiered double-digit royalties based on net sales.The company said Miudella is the first hormone-free copper intrauterine device to be introduced in the US in more than 40 years.","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":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4588","OGN","BK4559","BK4007","LU2065171402.SGD","LU2065170008.USD","LU2065171311.SGD","LU2065169927.USD","BK4585"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2645902190","title":"Organon completes global MIUDELLA copper IUD licensing deal with Sebela","url":"https://stock-news.laohu8.com/highlight/detail?id=2645902190","media":"Reuters","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2645902190?lang=en_us&edition=fundamental","pubTime":"2026-06-22 19:30","pubTimestamp":1782127828,"startTime":"0","endTime":"0","summary":"Organon completed a global licensing deal with Sebela for exclusive rights to MIUDELLA, a hormone-free copper IUD.MIUDELLA won FDA clearance on Feb. 24, 2025; indicated to prevent pregnancy for up to three years; 99% effective.Commercial launch targeted for late 2026; US distribution restricted to a REMS program requiring provider training.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. Organon & Co. published the original content used to generate this news brief via Business Wire  on June 22, 2026, and is solely responsible for the information contained therein.","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:20260622:nNDL2P8wwx:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU2065171311.SGD","BK4585","LU2065170008.USD","OGN","BK4588","BK4559","BK4007","LU2065169927.USD","LU2065171402.SGD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2645624021","title":"Organon Completes Agreement to License Miudella®, Sebela Pharmaceuticals’ Hormone-Free Intrauterine Device","url":"https://stock-news.laohu8.com/highlight/detail?id=2645624021","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2645624021?lang=en_us&edition=fundamental","pubTime":"2026-06-22 19:30","pubTimestamp":1782127800,"startTime":"0","endTime":"0","summary":null,"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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260622:nTUA1ZSCRN: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","LU2065171311.SGD","OGN","LU2065171402.SGD","BK4588","BK4559","BK4007","LU2065170008.USD","LU2065169927.USD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2645219200","title":"Organon & Co - Miudella Expected to Be Commercially Available in Late 2026","url":"https://stock-news.laohu8.com/highlight/detail?id=2645219200","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2645219200?lang=en_us&edition=fundamental","pubTime":"2026-06-22 19:30","pubTimestamp":1782127800,"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:20260622:nTUA1ZSCRN:2","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["LU2065169927.USD","BK4007","BK4588","LU2065171402.SGD","BK4559","BK4585","LU2065171311.SGD","OGN","LU2065170008.USD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644980702","title":"Organon and Samsung Bioepis expand commercialization agreement for Pyzchiva","url":"https://stock-news.laohu8.com/highlight/detail?id=2644980702","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644980702?lang=en_us&edition=fundamental","pubTime":"2026-06-18 18:13","pubTimestamp":1781777588,"startTime":"0","endTime":"0","summary":"Samsung Bioepis and Organon (OGN), a global healthcare company with expertise in biosimilars, announced the expansion of their development and comm...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/organon-and-samsung-bioepis-expand-commercialization-agreement-for-pyzchiva-thefly-news?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/organon-and-samsung-bioepis-expand-commercialization-agreement-for-pyzchiva-thefly-news?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":["LU2065169927.USD","OGN","BK4585","BK4007","BK4550","VHT","EMXC","IEMG","IXJ","LU2065171402.SGD","BK4559","BK4504","LU2065170008.USD","LU2065171311.SGD","BK4581","BK4588"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644416704","title":"Organon, Samsung Bioepis expand Canada commercialization pact for ustekinumab biosimilar PYZCHIVA","url":"https://stock-news.laohu8.com/highlight/detail?id=2644416704","media":"Reuters","labels":["corporation"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644416704?lang=en_us&edition=fundamental","pubTime":"2026-06-18 18:00","pubTimestamp":1781776843,"startTime":"0","endTime":"0","summary":"Organon expanded its partnership with Samsung Bioepis to secure exclusive commercialization rights in Canada for PYZCHIVA, a Stelara-referencing ustekinumab biosimilar.Samsung Bioepis retains responsibility for development, manufacturing, regulatory filings; Organon takes commercial execution in Canada.Launch is expected in 2026, adding a sixth product to the companies’ Canadian biosimilar collaboration.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. Organon & Co. published the original content used to generate this news brief via Business Wire  on June 18, 2026, and is solely responsible for the information contained therein.","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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260618:nNDLc7vC5Z:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"corporation","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU2065169927.USD","LU2065171311.SGD","LU2065171402.SGD","OGN","BK4559","BK4585","BK4588","LU2065170008.USD","BK4007"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644704465","title":"Organon & Co - Pyzchiva Expected to Launch in Canada in 2026","url":"https://stock-news.laohu8.com/highlight/detail?id=2644704465","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644704465?lang=en_us&edition=fundamental","pubTime":"2026-06-18 18:00","pubTimestamp":1781776800,"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:20260618:nTUA2P19CS:2","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4559","LU2065170008.USD","OGN","BK4007","LU2065171311.SGD","BK4588","LU2065171402.SGD","BK4585","LU2065169927.USD"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644704441","title":"Organon & Co - Agreement Expands Biosimilar Collaboration in Canada to Six Products","url":"https://stock-news.laohu8.com/highlight/detail?id=2644704441","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2644704441?lang=en_us&edition=fundamental","pubTime":"2026-06-18 18:00","pubTimestamp":1781776800,"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:20260618:nTUA2P19CS:3","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["LU2065171311.SGD","BK4007","LU2065170008.USD","BK4559","BK4588","LU2065169927.USD","LU2065171402.SGD","BK4585","OGN"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2644445704","title":"Organon & Co - 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The company’s shares closed yesterday at €4.4...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/shore-capital-reaffirms-their-buy-rating-on-origin-enterprises-plc-ogn-blurbs-news?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/shore-capital-reaffirms-their-buy-rating-on-origin-enterprises-plc-ogn-blurbs-news?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":["OGN"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2642789231","title":"Organon shareholders approve amended 2021 incentive stock plan, adding 8 million shares","url":"https://stock-news.laohu8.com/highlight/detail?id=2642789231","media":"Reuters","labels":["executive","shareholding"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2642789231?lang=en_us&edition=fundamental","pubTime":"2026-06-12 04:16","pubTimestamp":1781209019,"startTime":"0","endTime":"0","summary":"Organon held its annual shareholder meeting on June 9, 2026.Shareholders adopted an amended and restated 2021 Incentive Stock Plan, lifting the share pool by 8 million shares.Shareholders backed the company’s slate of director nominees; the vote confirmed the board’s proposed lineup.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. Organon & Co. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission , on June 11, 2026, and is solely responsible for the information contained therein.","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:20260611:nNDL9s3rDN:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"executive,shareholding","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU2065169927.USD","OGN","LU2065170008.USD","BK4007","BK4585","LU2065171402.SGD","BK4588","LU2065171311.SGD","BK4559"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2642426579","title":"Organon wins US approval to widen use of arthritis biosimilar drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2642426579","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2642426579?lang=en_us&edition=fundamental","pubTime":"2026-06-10 20:40","pubTimestamp":1781095209,"startTime":"0","endTime":"0","summary":"June 10  - Organon OGN.N said on Wednesday the U.S. Food and Drug Administration has approved the expanded use of its arthritis drug, a biosimilar to Roche's ROPC.S Actemra, to treat a lifethreatening immune reaction in some cancer patients and COVID-19 in patients needing breathing support.Here are a few details:The FDA approval expands use of its biosimilar, Tofidence, to treat severe or lifethreatening cytokine release syndrome in some cancer patients and for COVID19 patients who are receiving oxygen or breathing support and systemic corticosteroids.In cytokine release syndrome, the body releases excessive inflammatory proteins.","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://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20260610:nL4N42I0WX:1","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":["LU2065169927.USD","LU2065171402.SGD","BK4588","LU2065171311.SGD","BK4585","BK4007","OGN","LU2065170008.USD","BK4559"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2642425542","title":"Organon Expands Tofidence Label With FDA Approval for Additional Indications","url":"https://stock-news.laohu8.com/highlight/detail?id=2642425542","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2642425542?lang=en_us&edition=fundamental","pubTime":"2026-06-10 20:03","pubTimestamp":1781093014,"startTime":"0","endTime":"0","summary":"Organon  said Wednesday that the US Food and Drug Administration has approved a supplemental Biologics License Application expanding the indications for Tofidence, a biosimilar to Actemra.The expanded label covers treatment of cytokine release syndrome after CAR T-cell therapy and use in hospitalized COVID-19 patients aged 2 and older requiring oxygen support or ventilatory assistance, the company added.Organon said the expanded approval helps improve access to high-cost biologic treatments, but also noted that the drug is associated with serious safety risks, including infections such as tuberculosis and potential liver injury.Tofidence was first approved in 2024 and is already indicated for rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis, it added.","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":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["LU2065171311.SGD","LU2065171402.SGD","LU2065170008.USD","BK4007","BK4588","LABU","LU2065169927.USD","BK4559","OGN","BK4585"],"isVideo":false,"video":null,"gpt_icon":0},{"id":"2642231494","title":"Organon announces U.S. FDA approval pf sBLA for Tofidence injection","url":"https://stock-news.laohu8.com/highlight/detail?id=2642231494","media":"TIPRANKS","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2642231494?lang=en_us&edition=fundamental","pubTime":"2026-06-10 19:34","pubTimestamp":1781091251,"startTime":"0","endTime":"0","summary":"Organon (OGN) announced the US Food and Drug Administratio, FDA, approval of the supplemental Biologics License Application, sBLA, for Tofidence in...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/organon-announces-u-s-fda-approval-pf-sbla-for-tofidence-injection-thefly-news?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/organon-announces-u-s-fda-approval-pf-sbla-for-tofidence-injection-thefly-news?utm_source=itigerup.com&utm_medium=referral","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":"tipranks_highlight","symbols":["LU2065169927.USD","LU2065171311.SGD","LU2065171402.SGD","OGN","BK4559","BK4585","BK4588","LU2065170008.USD","LABU","BK4007"],"isVideo":false,"video":null,"gpt_icon":0}],"pageSize":20,"totalPage":8,"pageCount":2,"totalSize":142,"code":"91000000","status":"200"}]}}