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ORTHOCELL LTD

1.320

-0.005-0.38%

Volume:524.12K

Turnover:696.02K

Market Cap:319.41M

PE:-82.82

High:1.355

Open:1.340

Low:1.300

Close:1.325

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Overview Company News Filings

Orthocell Appoints First US Distributors for Nerve Repair Product; Shares Rise 6%

MT Newswires Live

BUZZ-Australia's Orthocell rises as co secures US distributors for flagship product

Orthocell - First US Distributors Signed for Remplirs

THOMSON REUTERS

Federal Reserve Chair Powell Suggests Easing Bank Cryptocurrency Rules

BUZZ-Australia's Orthocell rises on sales approval application in Hong Kong

BRIEF-Orthocell Submits Regulatory Application To Commence Sales Of Remplir In Hong Kong

Orthocell - Submits Regulatory Application to Commence Sales of Remplir in Hong Kong

THOMSON REUTERS

BRIEF-Orthocell Receives Regulatory Approval For Striate+ In Brazil

Orthocell Secures Regulatory Approval for Dental Membrane Product in Brazil

MT Newswires Live

Orthocell Ltd - Receives Regulatory Approval for Striate+ in Brazil

THOMSON REUTERS

Orthocell's Remplir FDA Clearance 'Major Milestone', Says Euroz Hartleys

MT Newswires Live

Friday’s HotCopper Trends: Mesoblast dodges tariffs, Orthocell’s FDA tick | April 4, 2025

The Market Herald

BUZZ-Australia's Orthocell rises on FDA nod for US launch of nerve repair drug

BRIEF-Orthocell Says Got US FDA 510(K) Clearance For Remplir To Commence Commercial Distribution

Why Ansell, Capricorn Metals, Orthocell, and Sonic Healthcare shares are charging higher

Orthocell Receives US FDA Clearance for Nerve Repair Product; Shares Down 4%

MT Newswires Live

Orthocell - Received US FDA 510(K) Clearance for Remplir to Commence Commercial Distribution in US Market

THOMSON REUTERS

This company has entered a trading halt, is it about to announce FDA approval?

BRIEF-Orthocell Seeks Trading Halt

Orthocell - Seeks Trading Halt Pending Announcement on Results of US FDA 510(K) Clearance Application to Begin Commercial Distribution in US

THOMSON REUTERS

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Orthocell Ltd OCC.AX:SUBMITS REGULATORY APPLICATION TO COMMENCE SALES OF REMPLIR IN HONG KONGSource text: ID:nASX4CpYkCFurther company coverage: OCC.AX ((Reuters.Briefs@thomsonreuters.com;))","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["earning"],"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:20250410:nFWN3QN23A: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":["OCC.AU"],"gpt_icon":0},{"id":"2526347210","title":"Orthocell -  Submits Regulatory Application to Commence Sales of Remplir in Hong Kong","url":"https://stock-news.laohu8.com/highlight/detail?id=2526347210","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2526347210?lang=en_us&edition=fundamental","pubTime":"2025-04-10 07:00","pubTimestamp":1744239655,"startTime":"0","endTime":"0","summary":null,"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:20250409:nFWN3QN23A: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":["OCC.AU","BK7508","BK7067"],"gpt_icon":0},{"id":"2526487922","title":"BRIEF-Orthocell Receives Regulatory Approval For Striate+ In Brazil","url":"https://stock-news.laohu8.com/highlight/detail?id=2526487922","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2526487922?lang=en_us&edition=fundamental","pubTime":"2025-04-09 09:31","pubTimestamp":1744162267,"startTime":"0","endTime":"0","summary":"BRIEF-Orthocell Receives Regulatory Approval For Striate+ In BrazilApril 9 (Reuters) - Orthocell Ltd OCC.AX:RECEIVES REGULATORY APPROVAL FOR STRIATE+ IN BRAZILSource text: ID:nASX7fDCGKFurther company coverage: OCC.AX ((Reuters.Briefs@thomsonreuters.com;))","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:20250409:nFWN3QM241:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK7508","OCC.AU","BK7067"],"gpt_icon":0},{"id":"2526687528","title":"Orthocell Secures Regulatory Approval for Dental Membrane Product in Brazil","url":"https://stock-news.laohu8.com/highlight/detail?id=2526687528","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2526687528?lang=en_us&edition=fundamental","pubTime":"2025-04-09 09:00","pubTimestamp":1744160432,"startTime":"0","endTime":"0","summary":"Orthocell  received regulatory approval from the Brazilian Health Regulatory Agency for its Striate+ dental membrane for guided bone and tissue regeneration applications, according to a Wednesday filing with the Australian bourse.The company is working with BioHorizons, its global marketing and distribution partner, to launch the product and expects commercial distribution in the fourth quarter of the year, the filing said.Shares rose past 2% in morning trade Wednesday.","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.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":["BK7508","OCC.AU","BK7067"],"gpt_icon":0},{"id":"2526822847","title":"Orthocell Ltd -  Receives Regulatory Approval for Striate+ in Brazil","url":"https://stock-news.laohu8.com/highlight/detail?id=2526822847","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2526822847?lang=en_us&edition=fundamental","pubTime":"2025-04-09 07:20","pubTimestamp":1744154422,"startTime":"0","endTime":"0","summary":null,"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:20250408:nFWN3QM241:1","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":["OCC.AU","BK7508","BK7067"],"gpt_icon":0},{"id":"2525834054","title":"Orthocell's Remplir FDA Clearance 'Major Milestone', Says Euroz Hartleys","url":"https://stock-news.laohu8.com/highlight/detail?id=2525834054","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2525834054?lang=en_us&edition=fundamental","pubTime":"2025-04-08 14:26","pubTimestamp":1744093605,"startTime":"0","endTime":"0","summary":"Orthocell's  recently secured FDA clearance for its nerve repair product, Remplir marked a \"major milestone\" and \"de-risking event\" for the company, said Euroz Hartley in a Monday note.The company received regulatory clearance from the US Food and Drug Administration for the product, under the 510 pathway, allowing sales in the US market, according to a Friday filing with the Australian bourse.The research firm noted that the approval enables Remplir to access the $1.6 billion US nerve repair market.Euroz Hartleys raised its price target from AU$0.97 to AU$1.19 while maintaining a hold rating.The company's shares fell 4% on market close.","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":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["OCC.AU","BK7067","BK7508"],"gpt_icon":0},{"id":"2524478612","title":"Friday’s HotCopper Trends: Mesoblast dodges tariffs, Orthocell’s FDA tick | April 4, 2025","url":"https://stock-news.laohu8.com/highlight/detail?id=2524478612","media":"The Market Herald","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524478612?lang=en_us&edition=fundamental","pubTime":"2025-04-04 09:57","pubTimestamp":1743731820,"startTime":"0","endTime":"0","summary":"The ASX has been down 1.5% at 7,739 points this morning.There’s been carnage on the ASX and the Energy sector has been enduring a bloodbath, followed by IT and Utilities.Staples and Health Care are the only sectors in positive territory so far.In company news, Mesoblast  has been among the most watched on HotCopper forums today after the medicinal company confirmed its belief its products will not be subject to United States tariffs.Orthocell  has also been trending on news the US FDA has given the green light for the company’s nerve repair product, Remplir, to be sold in the States.And, finally, Bellevue Gold  has provided an update saying it’s not yet in a position to make an announcement about the potential downward adjustment to its FY25 production guidance.Levy beef: Trump whacks Oz with 10% tariffs on “Liberation Day”。The material provided in this article is for information only and should not be treated as investment advice. Viewers are encouraged to conduct their own research a","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://themarketonline.com.au/fridays-hotcopper-trends-mesoblast-dodges-tariffs-orthocells-fda-tick-april-4-2025-2025-04-04/","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":"markerherald_stock","symbols":["MESO","OCC.AU","BK7508","BGL.AU","BK7104","BK7067","BK7501","BK4139","MSB.AU"],"gpt_icon":0},{"id":"2524425712","title":"BUZZ-Australia's Orthocell rises on FDA nod for US launch of nerve repair drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2524425712","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524425712?lang=en_us&edition=fundamental","pubTime":"2025-04-04 09:49","pubTimestamp":1743731350,"startTime":"0","endTime":"0","summary":"BUZZ-Australia's Orthocell rises on FDA nod for US launch of nerve repair drug** Orthocell OCC.AX jumps 7% to A$1.53; set for biggest intraday percentage gain since March 17** Biotech firm receives U.","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:20250404:nL3N3QI02L: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":["OCC.AU","BK7508","BK7067"],"gpt_icon":0},{"id":"2524242328","title":"BRIEF-Orthocell Says Got US FDA 510(K) Clearance For Remplir To Commence Commercial Distribution","url":"https://stock-news.laohu8.com/highlight/detail?id=2524242328","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524242328?lang=en_us&edition=fundamental","pubTime":"2025-04-04 09:47","pubTimestamp":1743731256,"startTime":"0","endTime":"0","summary":"BRIEF-Orthocell Says Got US FDA 510(K) Clearance For Remplir To Commence Commercial DistributionApril 4 (Reuters) - Orthocell Ltd OCC.AX:RECEIVED US FDA 510(K) CLEARANCE FOR REMPLIR TO COMMENCE COMMER","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:20250404:nFWN3QH0LZ: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":["OCC.AU","BK7508","BK7067"],"gpt_icon":0},{"id":"2524924232","title":"Why Ansell, Capricorn Metals, Orthocell, and Sonic Healthcare shares are charging higher","url":"https://stock-news.laohu8.com/highlight/detail?id=2524924232","media":"MotleyFool","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524924232?lang=en_us&edition=fundamental","pubTime":"2025-04-04 09:37","pubTimestamp":1743730655,"startTime":"0","endTime":"0","summary":"TheS&P/ASX 200 Index(ASX: XJO) is having a tough finish to the week. In afternoon trade, the benchmark index is down 1.45% to 7,743.4 points. Four ASX shares that are not letting that hold them back a","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.fool.com.au/2025/04/04/why-ansell-capricorn-metals-orthocell-and-sonic-healthcare-shares-are-charging-higher/","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":"motleyfoolau_stock","symbols":["LU2750360997.AUD","BK7508","OCC.AU","BK7126","BK4516","IE00BSNM7G36.USD","LU0048573561.USD","BK4533","LU2237443465.HKD","ANN.AU","IE0034235188.USD","LU2237443895.HKD","LU2471134952.CNY","LU1668664300.SGD","BK4504","IE0004086264.USD","BK4550","LU2237438978.USD","LU2471134879.HKD","HCSG","IE00BFXG1179.USD","BK4127","BK4588","IE00B19Z3B42.SGD","LU1868836914.USD","LU0106831901.USD","LU2237443622.USD","BK7104","XJO.AU","LU2750360641.GBP","LU0061475181.USD","LU2237443978.SGD","LU0251131958.USD","LU1868837136.USD","LU2237443549.SGD","LU0742534661.SGD","LU2471134796.USD","SHL.AU","IE0002270589.USD","BK4137","LU1868836757.USD","LU2471134523.USD","CMM.AU","BK4552","BK4585","IE0004091025.USD","LU0251142724.SGD","IE00B19Z3581.USD","BK7124","LU1791807156.HKD"],"gpt_icon":0},{"id":"2524243038","title":"Orthocell Receives US FDA Clearance for Nerve Repair Product; Shares Down 4%","url":"https://stock-news.laohu8.com/highlight/detail?id=2524243038","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524243038?lang=en_us&edition=fundamental","pubTime":"2025-04-04 08:00","pubTimestamp":1743724841,"startTime":"0","endTime":"0","summary":"Orthocell  received regulatory clearance from the US Food and Drug Administration for its nerve repair product, Remplir, under the 510 pathway, allowing sales in the US market, according to a Friday filing with the Australian bourse.Products delivered to the US will be manufactured at the company's Western Australia facility, the filing said.Remplir is approved for sale in Australia, New Zealand, and Singapore, with pending approvals in Canada and Thailand in the next six months, according to the filing.Shares were down 4% in morning trade Friday.","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":["OCC.AU","XKO.AU","BK7508","XAO.AU","BK7067","XJO.AU"],"gpt_icon":0},{"id":"2524621226","title":"Orthocell - Received US FDA 510(K) Clearance for Remplir to Commence Commercial Distribution in US Market","url":"https://stock-news.laohu8.com/highlight/detail?id=2524621226","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524621226?lang=en_us&edition=fundamental","pubTime":"2025-04-04 06:24","pubTimestamp":1743719079,"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:20250403:nFWN3QH0LZ: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":["BK7067","OCC.AU","BK7508"],"gpt_icon":0},{"id":"2524724363","title":"This company has entered a trading halt, is it about to announce FDA approval?","url":"https://stock-news.laohu8.com/highlight/detail?id=2524724363","media":"MotleyFool","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524724363?lang=en_us&edition=fundamental","pubTime":"2025-04-04 05:56","pubTimestamp":1743717416,"startTime":"0","endTime":"0","summary":"Given the timeline and the current trading halt, it is highly possible that Orthocell has received the FDA's decision and is preparing to announce the outcome. If the FDA has granted 510 clearance, Orthocell will be authorised to commence commercial distribution of Remplir in the U.S. This would mean access to the substantial U.S. nerve repair market. If the clearance was not granted, the company may need to address the FDA's concerns before proceeding. Following a trading halt, If the halted stock resumes trading with good news, such as FDA approval , investor demand usually drives up the share price. Investors should keep an eye out for further announcements which, based on the media release, could come as early as today.","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.fool.com.au/2025/04/04/this-company-has-entered-a-trading-halt-is-it-about-to-announce-fda-approval/","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":"motleyfoolau_stock","symbols":["BK7067","OCC.AU","BK7508"],"gpt_icon":0},{"id":"2524230447","title":"BRIEF-Orthocell Seeks Trading Halt","url":"https://stock-news.laohu8.com/highlight/detail?id=2524230447","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524230447?lang=en_us&edition=fundamental","pubTime":"2025-04-03 06:26","pubTimestamp":1743632807,"startTime":"0","endTime":"0","summary":"BRIEF-Orthocell Seeks Trading HaltApril 3 (Reuters) - Orthocell Ltd OCC.AX:SEEKS TRADING HALT PENDING ANNOUNCEMENT ON RESULTS OF US FDA 510(K) CLEARANCE APPLICATION TO BEGIN COMMERCIAL DISTRIBUTION IN USFurther company coverage: OCC.AX ((Reuters.Briefs@thomsonreuters.com;))","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:20250402:nFWN3QG1BZ: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":["BK7508","OCC.AU","BK7067"],"gpt_icon":0},{"id":"2524442067","title":"Orthocell - Seeks Trading Halt Pending Announcement on Results of US FDA 510(K) Clearance Application to Begin Commercial Distribution in US","url":"https://stock-news.laohu8.com/highlight/detail?id=2524442067","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2524442067?lang=en_us&edition=fundamental","pubTime":"2025-04-03 06:07","pubTimestamp":1743631655,"startTime":"0","endTime":"0","summary":null,"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:20250402:nFWN3QG1BZ: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":["OCC.AU","BK7508","BK7067"],"gpt_icon":0}],"pageSize":20,"totalPage":5,"pageCount":2,"totalSize":82,"code":"91000000","status":"200"}],"@#url:\"https://hq.skytigris.cn/fundamental/corporate_actions/details/OCC.AU\",params:#limit:5,,,undefined,":[],"@#url:\"https://hq.skytigris.cn/fundamental/dividend/history\",params:#symbol:\"OCC.AU\",market:\"AU\",,,undefined,":[]}}