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LPCN 1154  as a treatment for PPD. In the meeting,Lipocine was advised that the FDA believes that, in addition to the. previously completed PK bridge data, a safety and efficacy study of oral. LPCN 1154 in the target population will be required for 505 NDA. submission. Based on observed comparable exposure of LPCN 1154 and the. reference drug in the PK bridge study, the company is initiating a phase. 3 safety a","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":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4099","03160","LPCN","BK4561","BK4530","BK4604","TM","UAE","BK4007","KOL","BK4135","BK4585","BK4555","BK4588","PPD","BK4121","GCC","CNS"],"gpt_icon":0},{"id":"2516636102","title":"Lipocine Inc  expected to post a loss of 40 cents a share - Earnings Preview","url":"https://stock-news.laohu8.com/highlight/detail?id=2516636102","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516636102?lang=en_us&edition=fundamental","pubTime":"2025-03-03 21:45","pubTimestamp":1741009506,"startTime":"0","endTime":"0","summary":"Lipocine Inc  expected to post a loss of40cents a share - Earnings Preview Lipocine Inc LPCN.OQ LPCN.O is expected to show a rise in quarterly revenue when it reports  results on March 5 (estimated) f","market":"nz","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:20250303:nL5N3PM149:1","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":["LPCN"],"gpt_icon":0},{"id":"2509273293","title":"Lipocine receives updated regulatory guidance on LPCN 1154","url":"https://stock-news.laohu8.com/highlight/detail?id=2509273293","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509273293?lang=en_us&edition=fundamental","pubTime":"2025-02-06 21:10","pubTimestamp":1738847432,"startTime":"0","endTime":"0","summary":"Lipocine (LPCN) received revised regulatory guidance for LPCN 1154 which the company is developing for postpartum depression treatment. The company...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/lipocine-receives-updated-regulatory-guidance-on-lpcn-1154?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/lipocine-receives-updated-regulatory-guidance-on-lpcn-1154?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":["BK4007","LPCN"],"gpt_icon":0},{"id":"2509731162","title":"Lipocine Inc - FDA Requires Efficacy and Safety Study for Lpcn 1154 Nda Submission","url":"https://stock-news.laohu8.com/highlight/detail?id=2509731162","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509731162?lang=en_us&edition=fundamental","pubTime":"2025-02-06 21:00","pubTimestamp":1738846803,"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:20250206:nTUABSWDTR: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":["LPCN","BK4007"],"gpt_icon":0},{"id":"2509273822","title":"Lipocine Receives Updated Regulatory Guidance on Lpcn 1154","url":"https://stock-news.laohu8.com/highlight/detail?id=2509273822","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509273822?lang=en_us&edition=fundamental","pubTime":"2025-02-06 21:00","pubTimestamp":1738846803,"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:20250206:nTUABSWDTR: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":["LPCN","BK4007"],"gpt_icon":0},{"id":"2509273197","title":"Lipocine Inc - Plans Phase 3 Safety and Efficacy Study for Lpcn 1154","url":"https://stock-news.laohu8.com/highlight/detail?id=2509273197","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509273197?lang=en_us&edition=fundamental","pubTime":"2025-02-06 21:00","pubTimestamp":1738846803,"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:20250206:nTUABSWDTR: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":["LPCN","BK4007"],"gpt_icon":0},{"id":"2509273678","title":"Lipocine Receives Updated Regulatory Guidance on LPCN 1154","url":"https://stock-news.laohu8.com/highlight/detail?id=2509273678","media":"PR Newswire","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2509273678?lang=en_us&edition=fundamental","pubTime":"2025-02-06 21:00","pubTimestamp":1738846800,"startTime":"0","endTime":"0","summary":"SALT LAKE CITY, Feb. 6, 2025 /PRNewswire/ -- Lipocine Inc. , a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced receipt of revised regulatory guidance for LPCN 1154 which the Company is developing for postpartum depression  treatment. As previously disclosed, the Company was scheduled to meet with the U.S. Food and Drug Administration  in Q1 2025 to discuss the NDA submission package of LPCN 1154. Following the meeting, the Company was advised that the Division believes, in addition to the previously completed PK bridge data, an efficacy and safety study of oral LPCN 1154 in the target populationwillbe required for 505 NDA submission.Lipocine remains committed to advancing a rapid relief treatment for postpartum depression. Based on the guidance received and observed comparable exposure of LPCN 1154 and the reference drug in the completed PK bridge study, Lipocine is planning next steps tow","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/lipocine-receives-updated-regulatory-guidance-130000094.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/lipocine-receives-updated-regulatory-guidance-130000094.html","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":"yahoofinance","symbols":["LPCN","PPD","BK4530","BK4121","BK4561","BK4007"],"gpt_icon":0},{"id":"2492967843","title":"Lipocine Says LPCN 1148 Gets FDA Fast Track Label","url":"https://stock-news.laohu8.com/highlight/detail?id=2492967843","media":"MT Newswires Live","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492967843?lang=en_us&edition=fundamental","pubTime":"2024-12-18 00:26","pubTimestamp":1734452803,"startTime":"0","endTime":"0","summary":"Lipocine (LPCN) said Tuesday that LPCN 1148 has received fast track designation from the US Food and Drug Administration as a treatment for sarcopenia in patients with decompensated cirrhosis.Sarcopen","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://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":["FAST","LPCN","IE00B5TLWC47.USD","BK4567","BK4588","IE00BYQQ9H92.USD","BK4104","IE00BFXG0V08.USD","BK4585","BK4007"],"gpt_icon":0},{"id":"2492954337","title":"FDA Grants Fast Track Designation to Lipocine for Lpcn 1148 as a Treatment for Sarcopenia in Patients With Decompensated Cirrhosis","url":"https://stock-news.laohu8.com/highlight/detail?id=2492954337","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492954337?lang=en_us&edition=fundamental","pubTime":"2024-12-17 21:00","pubTimestamp":1734440411,"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:20241217:nTUA3QGK0J: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":["BK4007","LPCN"],"gpt_icon":0},{"id":"2492954965","title":"FDA Grants Fast Track Designation to Lipocine for LPCN 1148 as a Treatment for Sarcopenia in Patients with Decompensated Cirrhosis","url":"https://stock-news.laohu8.com/highlight/detail?id=2492954965","media":"PR Newswire","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2492954965?lang=en_us&edition=fundamental","pubTime":"2024-12-17 21:00","pubTimestamp":1734440400,"startTime":"0","endTime":"0","summary":"SALT LAKE CITY, Dec. 17, 2024 /PRNewswire/ -- Lipocine Inc. , a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced that the U.S. Food and Drug Administration  has granted Fast Track Designation to LPCN 1148 as a treatment for sarcopenia in patients with decompensated cirrhosis. LPCN 1148, an oral prodrug of bioidentical testosterone, was recently studied in a proof-of-concept Phase 2 study in patients with decompensated cirrhosis. Treatment with LPCN 1148 in thePOCstudy improved sarcopenia and associated clinical outcomes. LPCN 1148 is targeted to be a \"First in Class\" product candidate with a novel mechanism of action for management of cirrhosis.Over 382,000 patients have been diagnosed with decompensated liver cirrhosis in the US, with few options for managing their disease other than liver transplant. Poor quality of life is common while waiting for a liver transplant. Although there is a ","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/Uglf3Px7j8DIB2d.1k7qAw--~B/aD0xMTM7dz00MDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/prnewswire.com/62a81ae3d468802b850c2f8f9ddf2cd2","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/Uglf3Px7j8DIB2d.1k7qAw--~B/aD0xMTM7dz00MDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/prnewswire.com/62a81ae3d468802b850c2f8f9ddf2cd2"],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/fda-grants-fast-track-designation-130000015.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/fda-grants-fast-track-designation-130000015.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4588","IE00B5TLWC47.USD","BK4007","IE00BYQQ9H92.USD","BK4104","IE00BFXG0V08.USD","FAST","BK4585","LPCN","BK4567"],"gpt_icon":0},{"id":"2484676340","title":"BRIEF-Lipocine Announces Publication And Discussion Of LPCN 1148 Manuscript At The Liver Meeting 2024 Editor's Cut Session","url":"https://stock-news.laohu8.com/highlight/detail?id=2484676340","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484676340?lang=en_us&edition=fundamental","pubTime":"2024-11-18 22:40","pubTimestamp":1731940818,"startTime":"0","endTime":"0","summary":"Nov 18 (Reuters) - Canadian National Railway Co :   * LIPOCINE ANNOUNCES PUBLICATION AND DISCUSSION OF LPCN 1148 MANUSCRIPT AT THE LIVER MEETING 2024 EDITOR'S CUT SESSIONSource text:    Further company coverage:    ((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.rkd.refinitiv.com/api/News/News.svc/REST/News_1/RetrieveStoryML_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":["BK4007","LPCN"],"gpt_icon":0},{"id":"2484627509","title":"Lipocine announces publication, discussion of LPCN 1148","url":"https://stock-news.laohu8.com/highlight/detail?id=2484627509","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484627509?lang=en_us&edition=fundamental","pubTime":"2024-11-18 21:16","pubTimestamp":1731935770,"startTime":"0","endTime":"0","summary":"Lipocine (LPCN) announced the publication and discussion of a manuscript “Oral LPCN 1148 Improves Sarcopenia and Hepatic Encephalopathy in Male Pat...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/lipocine-announces-publication-discussion-of-lpcn-1148?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/lipocine-announces-publication-discussion-of-lpcn-1148?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":["LPCN","BK4007"],"gpt_icon":0},{"id":"2484247076","title":"Lipocine Announces Publication and Discussion of Lpcn 1148 Manuscript at the Liver Meeting 2024 Editor's Cut Session","url":"https://stock-news.laohu8.com/highlight/detail?id=2484247076","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484247076?lang=en_us&edition=fundamental","pubTime":"2024-11-18 21:00","pubTimestamp":1731934807,"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:20241118:nTUA4R3CTD: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":["LPCN","BK4007"],"gpt_icon":0},{"id":"2484667622","title":"Lipocine Announces Publication and Discussion of LPCN 1148 Manuscript at The Liver Meeting 2024 Editor's Cut Session","url":"https://stock-news.laohu8.com/highlight/detail?id=2484667622","media":"PR Newswire","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2484667622?lang=en_us&edition=fundamental","pubTime":"2024-11-18 21:00","pubTimestamp":1731934800,"startTime":"0","endTime":"0","summary":"SALT LAKE CITY, Nov. 18, 2024 /PRNewswire/ -- Lipocine Inc. , a biopharmaceutical company leveraging its proprietary technology platform to augment therapeutics through effective oral delivery, today announced the publication and discussion of a manuscript \"Oral LPCN 1148 Improves Sarcopenia and Hepatic Encephalopathy in Male Patients with Cirrhosis: a randomized, placebo-controlled Phase 2 trial\" in the journal Hepatology and discussion at The Liver Meeting  2024 Editor's Cut: Clinical Study Session held on November 16, 2024. LPCN 1148 is targeted to be a \"First in Class\" product candidate with a novel mechanism of action for overt hepatic encephalopathy and sarcopenia indications. A copy of the publication can be accessed here.The publication features the results from a Phase 2 proof-of-concept clinical trial  that evaluated LPCN 1148 in men with cirrhosis and sarcopenia awaiting liver transplantation. The trial was conducted in two stages. Stage 1 was double blind, placebo-controlle","market":"us","thumbnail":"https://s.yimg.com/uu/api/res/1.2/Uglf3Px7j8DIB2d.1k7qAw--~B/aD0xMTM7dz00MDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/prnewswire.com/62a81ae3d468802b850c2f8f9ddf2cd2","type":0,"news_type":0,"thumbnails":["https://s.yimg.com/uu/api/res/1.2/Uglf3Px7j8DIB2d.1k7qAw--~B/aD0xMTM7dz00MDA7YXBwaWQ9eXRhY2h5b24-/https://media.zenfs.com/en/prnewswire.com/62a81ae3d468802b850c2f8f9ddf2cd2"],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/lipocine-announces-publication-discussion-lpcn-130000789.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/lipocine-announces-publication-discussion-lpcn-130000789.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":["BK4007","LPCN"],"gpt_icon":1}],"pageSize":16,"totalPage":3,"pageCount":1,"totalSize":48}]}}