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Unicycive Therapeutics, Inc.

6.57

+0.29004.62%

Post-market: 6.50-0.0700-1.07%17:56 EST

Volume:540.54K

Turnover:3.52M

Market Cap:141.20M

PE:-4.10

High:6.67

Open:6.30

Low:6.28

Close:6.28

52wk High:11.00

52wk Low:3.71

Shares:21.49M

Float Shares:13.01M

Volume Ratio:1.39

T/O Rate:4.16%

Dividend:- -

Dividend Rate:- -

EPS(TTM):-1.6020

EPS(LYR):-5.6466

ROE:-102.29%

ROA:-44.23%

PB:3.77

PE(LYR):-1.16

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Overview Company News Filings

Unicycive Therapeutics management to meet with Piper Sandler

Unicycive Therapeutics initiated with a Buy at WestPark Capital

Unicycive Therapeutics Faces Shareholder Lawsuit Over Alleged False Statements

Unicycive Therapeutics Showcases Kidney Disease Drug Pipeline and Launch Plans for OLC

Unicycive Therapeutics to Participate in a Fireside Chat at Guggenheim’s Emerging Outlook: Biotech Summit

Unicycive Therapeutics Showcases Pipeline Advancements in Kidney Disease Treatments

Analysts Offer Insights on Healthcare Companies: Protagonist Therapeutics (PTGX) and Unicycive Therapeutics (UNCY)

De-Risked Regulatory Path and Commercial Readiness Underpin Buy Rating on Unicycive and Lead Asset OLC

BUZZ-U.S. STOCKS ON THE MOVE-Blackstone, Summit, Lockheed Martin

Unicycive Therapeutics Inc - FDA Assigns Pdufa Target Date of June 29, 2026

THOMSON REUTERS

Update - Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (Olc) New Drug Application (Nda) Resubmission

THOMSON REUTERS

BUZZ-Unicycive rises as FDA accepts resubmitted filing for kidney drug

Unicycive Therapeutics Inc - Pdufa Target Action Date Set for June 27, 2026

THOMSON REUTERS

Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission

Unicycive Therapeutics Showcases Kidney Disease Drug Pipeline and OLC Launch Plans in New Presentation

Unicycive Resubmits NDA for Oxylanthanum Carbonate to FDA

Unicycive Therapeutics Inc - Nda Submission Review Expected Within 6 Months per Prescription Drug User Fee Act

THOMSON REUTERS

Unicycive Therapeutics Inc - Nda Resubmitted After Vendor Resolves FDA Deficiencies

THOMSON REUTERS

Unicycive Therapeutics Announces Resubmission of New Drug Application (Nda) for Oxylanthanum Carbonate (Olc)

THOMSON REUTERS

Unicycive Therapeutics unveils new kidney disease treatment pipeline in latest corporate presentation

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Published first on TheFly – the ultimate source for real-time, market-moving...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/unicycive-therapeutics-management-to-meet-with-piper-sandler-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/unicycive-therapeutics-management-to-meet-with-piper-sandler-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":["UNCY","BK4139","BK4539"],"gpt_icon":0},{"id":"2612407075","title":"Unicycive Therapeutics initiated with a Buy at WestPark Capital","url":"https://stock-news.laohu8.com/highlight/detail?id=2612407075","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612407075?lang=en_us&edition=fundamental","pubTime":"2026-02-19 20:57","pubTimestamp":1771505858,"startTime":"0","endTime":"0","summary":"WestPark Capital initiated coverage of Unicycive Therapeutics (UNCY) with a Buy rating and $72 price target Given the view that a significant numbe...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/unicycive-therapeutics-initiated-with-a-buy-at-westpark-capital-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/unicycive-therapeutics-initiated-with-a-buy-at-westpark-capital-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":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["BK4139","UNCY","BK4539"],"gpt_icon":0},{"id":"2612507634","title":"Unicycive Therapeutics Faces Shareholder Lawsuit Over Alleged False Statements","url":"https://stock-news.laohu8.com/highlight/detail?id=2612507634","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2612507634?lang=en_us&edition=fundamental","pubTime":"2026-02-17 22:16","pubTimestamp":1771337760,"startTime":"0","endTime":"0","summary":"Grabar Law Office is investigating claims on behalf of shareholders of Unicycive Therapeutics Inc., alleging that certain officers and directors breached their fiduciary duties. The investigation centers on accusations that the company overstated its readiness to meet FDA manufacturing compliance requirements and exaggerated the regulatory prospects of its oxylanthanum carbonate new drug application, resulting in potentially false and misleading public statements. Shareholders who purchased shares before March 29, 2024, and still hold them may seek corporate reforms and the return of funds to the company.","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:20260217:nNDL4Fmyfg: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":["BK4139","BK4539","UNCY"],"gpt_icon":0},{"id":"2609251974","title":"Unicycive Therapeutics Showcases Kidney Disease Drug Pipeline and Launch Plans for OLC","url":"https://stock-news.laohu8.com/highlight/detail?id=2609251974","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2609251974?lang=en_us&edition=fundamental","pubTime":"2026-02-07 04:53","pubTimestamp":1770411189,"startTime":"0","endTime":"0","summary":"Unicycive Therapeutics Inc. has released a corporate presentation highlighting its progress in developing novel treatments for kidney disease. The company’s lead asset, oxylanthanum carbonate , is under review by the FDA for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. The New Drug Application  for OLC was resubmitted following resolution of manufacturing-related issues, and the FDA has set a Prescription Drug User Fee Act  date of June 29, 2026. Unicycive reports an expanded market opportunity for OLC, citing recent developments in the reimbursement landscape. The presentation also notes that the company’s pipeline includes UNI-494, in development for acute kidney injury and chronic kidney disease. The company states it has a cash runway into 2027 to support its ongoing development and potential commercial activities. You can access the full presentation through the link below.","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:20260206:nNDL16Mhk1:1","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":["BK4139","BK4539","UNCY"],"gpt_icon":0},{"id":"2608361393","title":"Unicycive Therapeutics to Participate in a Fireside Chat at Guggenheim’s Emerging Outlook: Biotech Summit","url":"https://stock-news.laohu8.com/highlight/detail?id=2608361393","media":"GlobeNewswire","labels":["conferences"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2608361393?lang=en_us&edition=fundamental","pubTime":"2026-02-04 20:05","pubTimestamp":1770206700,"startTime":"0","endTime":"0","summary":"LOS ALTOS, Calif., Feb.  04, 2026  (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “C","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.globenewswire.com/news-release/2026/02/04/3231919/0/en/Unicycive-Therapeutics-to-Participate-in-a-Fireside-Chat-at-Guggenheim-s-Emerging-Outlook-Biotech-Summit.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"conferences","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["UNCY","ODD","BK4139","BK4211","BK4588","BK4539","BK4183","BK4585","SMMF","LABU","IE0009354923.USD"],"gpt_icon":0},{"id":"2607493029","title":"Unicycive Therapeutics Showcases Pipeline Advancements in Kidney Disease Treatments","url":"https://stock-news.laohu8.com/highlight/detail?id=2607493029","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2607493029?lang=en_us&edition=fundamental","pubTime":"2026-01-31 04:47","pubTimestamp":1769806034,"startTime":"0","endTime":"0","summary":"Unicycive Therapeutics Inc. has released a corporate presentation detailing its progress in developing novel treatments for kidney diseases. The company’s lead asset, oxylanthanum carbonate , is being advanced for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. The OLC New Drug Application  was resubmitted to the FDA following the resolution of a manufacturing-related deficiency, and the FDA has assigned a PDUFA date of June 29, 2026. Unicycive reports a cash runway extending into 2027 to support the application resubmission, potential FDA approval, and commercial launch activities. The company also highlights ongoing development of UNI-494, targeting acute kidney injury and chronic kidney disease. OLC is being developed under the FDA’s 505 regulatory pathway and, if approved, will offer a formulation that is swallowed whole, differing from the reference-listed drug Fosrenol. The presentation notes that the market opportunity for hyperphosphatemia tre","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:20260130:nNDL672g6d: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":["BK4539","BK4139","UNCY"],"gpt_icon":0},{"id":"2607412870","title":"Analysts Offer Insights on Healthcare Companies: Protagonist Therapeutics (PTGX) and Unicycive Therapeutics (UNCY)","url":"https://stock-news.laohu8.com/highlight/detail?id=2607412870","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2607412870?lang=en_us&edition=fundamental","pubTime":"2026-01-30 22:40","pubTimestamp":1769784027,"startTime":"0","endTime":"0","summary":"There’s a lot to be optimistic about in the Healthcare sector as 2 analysts just weighed in on Protagonist Therapeutics (PTGX – Research Report) an...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/analysts-offer-insights-on-healthcare-companies-protagonist-therapeutics-ptgx-and-unicycive-therapeutics-uncy-blurbs?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/analysts-offer-insights-on-healthcare-companies-protagonist-therapeutics-ptgx-and-unicycive-therapeutics-uncy-blurbs?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":["BK4137","XBI","XLV","BK4539","UNCY","BK4585","LU0029874061.USD","BK4588","PTGX","BK4581","BK4139","HCSG","LU0128526141.USD","LABU"],"gpt_icon":0},{"id":"2607032094","title":"De-Risked Regulatory Path and Commercial Readiness Underpin Buy Rating on Unicycive and Lead Asset OLC","url":"https://stock-news.laohu8.com/highlight/detail?id=2607032094","media":"TIPRANKS","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2607032094?lang=en_us&edition=fundamental","pubTime":"2026-01-30 01:15","pubTimestamp":1769706928,"startTime":"0","endTime":"0","summary":"In a report released today, Swayampakula Ramakanth from H.C. 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FDA Assigns Pdufa Target Date of June 29, 2026","url":"https://stock-news.laohu8.com/highlight/detail?id=2607629033","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2607629033?lang=en_us&edition=fundamental","pubTime":"2026-01-29 22:15","pubTimestamp":1769696149,"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:20260129:nTUA5LK5HR: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":["BK4139","BK4539","UNCY"],"gpt_icon":0},{"id":"2607103362","title":"Update - Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (Olc) New Drug Application (Nda) Resubmission","url":"https://stock-news.laohu8.com/highlight/detail?id=2607103362","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2607103362?lang=en_us&edition=fundamental","pubTime":"2026-01-29 22:15","pubTimestamp":1769696149,"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:20260129:nTUA5LK5HR: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":["BK4139","BK4539","UNCY"],"gpt_icon":0},{"id":"2607846410","title":"BUZZ-Unicycive rises as FDA accepts resubmitted filing for kidney drug","url":"https://stock-news.laohu8.com/highlight/detail?id=2607846410","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2607846410?lang=en_us&edition=fundamental","pubTime":"2026-01-29 20:15","pubTimestamp":1769688949,"startTime":"0","endTime":"0","summary":"BUZZ-Unicycive rises as FDA accepts resubmitted filing for kidney drug** Shares of drug developer Unicycive Therapeutics UNCY.O rise 9.5% to $7.69 premarket** Co says FDA accepted for review its resubmitted application for oxylanthanum carbonate, a pill for high phosphate levels in dialysis patients** High phosphate levels occur in people with latestage kidney disease when the body cannot remove excess minerals, per co** Co says FDA raised no initial concerns on safety or effectiveness; decision expected by June 27** UNCY's drug aims to cut pill burden to help patients stay on treatment; possible launch later this year if approved, co says** Shares down ~27% in 2025  ","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:20260129:nL4N3YU1N5:1","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":["BK4139","BK4539","UNCY"],"gpt_icon":0},{"id":"2607407081","title":"Unicycive Therapeutics Inc - Pdufa Target Action Date Set for June 27, 2026","url":"https://stock-news.laohu8.com/highlight/detail?id=2607407081","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2607407081?lang=en_us&edition=fundamental","pubTime":"2026-01-29 20:05","pubTimestamp":1769688300,"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:20260129:nTUA4LBF1R: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":["BK4139","UNCY","BK4539"],"gpt_icon":0},{"id":"2607841680","title":"Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission","url":"https://stock-news.laohu8.com/highlight/detail?id=2607841680","media":"GlobeNewswire","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2607841680?lang=en_us&edition=fundamental","pubTime":"2026-01-29 20:05","pubTimestamp":1769688300,"startTime":"0","endTime":"0","summary":"DA assigns Prescription Drug User Fee Act (PDUFA) target date of June 27, 2026Ended 2025 with unaudited cash position of $41.3M with expected runway into 2027 LOS ALTOS, Calif., Jan.  29, 2026  (GLOBE","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.globenewswire.com/news-release/2026/01/29/3228435/0/en/Unicycive-Therapeutics-Announces-FDA-Acceptance-of-Oxylanthanum-Carbonate-OLC-New-Drug-Application-NDA-Resubmission.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"2","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["LU2237443382.USD","LU2237443465.HKD","UNCY","LU0267386448.USD","LU1363072403.SGD","LU2237443978.SGD","IE00BKVL7J92.USD","LU2746668461.USD","IE0009354923.USD","LU0170899867.USD","BK4183","IE00BFXG1179.USD","CMC","BK4006","LU0149725797.USD","IE00BZ1G4Q59.USD","IE00BHPRN162.USD","LU2237443622.USD","LU0882574139.USD","BK4539","LU2746668974.SGD","LU0971096721.USD","BK4139","LU2237443549.SGD","IE00B1BXHZ80.USD","ODD","LU2237443895.HKD"],"gpt_icon":0},{"id":"2601388971","title":"Unicycive Therapeutics Showcases Kidney Disease Drug Pipeline and OLC Launch Plans in New Presentation","url":"https://stock-news.laohu8.com/highlight/detail?id=2601388971","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2601388971?lang=en_us&edition=fundamental","pubTime":"2026-01-08 01:58","pubTimestamp":1767808733,"startTime":"0","endTime":"0","summary":"Unicycive Therapeutics Inc. has published a corporate presentation detailing its diversified pipeline focused on novel treatments for kidney disease. The company's lead asset, oxylanthanum carbonate , is being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. The New Drug Application  for OLC was resubmitted following progress in resolving FDA-cited deficiencies with a third-party manufacturing vendor, and a new PDUFA date is expected in the first half of 2026. Unicycive reports that OLC, if approved, will offer a smaller tablet that can be swallowed whole, distinguishing it from the reference-listed drug Fosrenol. The company also highlights ongoing development of UNI-494 for acute kidney injury. Unicycive states that recent developments in the reimbursement landscape have expanded the market opportunity for OLC, with the US market for hyperphosphatemia treatments estimated at over $1 billion. You can access the full presentation through ","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:20260107:nNDLbzgKG3:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","UNCY","BK4539"],"gpt_icon":0},{"id":"2595787536","title":"Unicycive Resubmits NDA for Oxylanthanum Carbonate to FDA","url":"https://stock-news.laohu8.com/highlight/detail?id=2595787536","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2595787536?lang=en_us&edition=fundamental","pubTime":"2025-12-29 20:05","pubTimestamp":1767009908,"startTime":"0","endTime":"0","summary":"Unicycive Therapeutics Inc. has resubmitted its New Drug Application  for oxylanthanum carbonate , an investigational oral phosphate binder for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis, to the U.S. Food and Drug Administration . The resubmission follows significant progress by Unicycive's third-party manufacturing vendor in addressing FDA-cited deficiencies and demonstrating inspection readiness. The FDA previously identified a single deficiency related to the manufacturing vendor's compliance status. No additional issues were raised during a recent Type A meeting with the FDA. The company expects a new Prescription Drug User Fee Act  date in the first half of 2026, with review expected to be completed within six months of NDA acceptance.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 informati","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:20251229:nNDL5zb82S: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":["LU2210149790.SGD","IE00B3QW5Z07.USD","SG9999014021.USD","IE00BKPKM429.USD","BK4585","BK4588","SG9999014013.SGD","IE00BGHQF748.EUR","LU0314104364.USD","UNCY","BK4539","NDAQ","SG9999014039.USD","BK4139","IE00B64PRP62.GBP","LU2210150020.SGD","LU2095319765.USD","BK4112","SG9999014005.SGD"],"gpt_icon":0},{"id":"2595787531","title":"Unicycive Therapeutics Inc - Nda Submission Review Expected Within 6 Months per Prescription Drug User Fee Act","url":"https://stock-news.laohu8.com/highlight/detail?id=2595787531","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2595787531?lang=en_us&edition=fundamental","pubTime":"2025-12-29 20:05","pubTimestamp":1767009900,"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:20251229:nTUA9SCFLH: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":["UNCY","BK4539","BK4139"],"gpt_icon":0},{"id":"2595787530","title":"Unicycive Therapeutics Inc - Nda Resubmitted After Vendor Resolves FDA Deficiencies","url":"https://stock-news.laohu8.com/highlight/detail?id=2595787530","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2595787530?lang=en_us&edition=fundamental","pubTime":"2025-12-29 20:05","pubTimestamp":1767009900,"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:20251229:nTUA9SCFLH: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":["UNCY","BK4139","BK4539"],"gpt_icon":0},{"id":"2595534787","title":"Unicycive Therapeutics Announces Resubmission of New Drug Application (Nda) for Oxylanthanum Carbonate (Olc)","url":"https://stock-news.laohu8.com/highlight/detail?id=2595534787","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2595534787?lang=en_us&edition=fundamental","pubTime":"2025-12-29 20:05","pubTimestamp":1767009900,"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:20251229:nTUA9SCFLH: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":["BK4539","BK4139","UNCY"],"gpt_icon":0},{"id":"2588065920","title":"Unicycive Therapeutics unveils new kidney disease treatment pipeline in latest corporate presentation","url":"https://stock-news.laohu8.com/highlight/detail?id=2588065920","media":"Reuters","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2588065920?lang=en_us&edition=fundamental","pubTime":"2025-12-03 04:22","pubTimestamp":1764706977,"startTime":"0","endTime":"0","summary":"Unicycive Therapeutics Inc. has released a corporate presentation detailing its current pipeline and development strategy in the field of kidney disease. The company's lead asset, oxylanthanum carbonate , is being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Unicycive plans to resubmit the New Drug Application  for OLC by the end of the year, following discussions with the FDA regarding the resolution of a previously identified manufacturing vendor compliance issue. If approved, OLC is expected to offer a lower pill burden compared to existing therapies, addressing a significant unmet need according to surveyed nephrologists. The company is also advancing UN-494, which is in development for the treatment of acute kidney injury and chronic kidney disease. Unicycive reports a cash runway extending into 2027 to support its ongoing clinical and commercial activities. You can access the full presentation through the link below.","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:20251202:nNDL3m38WM: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":["BK4539","BK4139","UNCY"],"gpt_icon":0}],"pageSize":20,"totalPage":3,"pageCount":1,"totalSize":45,"code":"91000000","status":"200"}]}}