Unicycive Therapeutics Showcases Kidney Disease Drug Pipeline and OLC Development Plans

Reuters

2025/10/30

Unicycive <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Showcases Kidney Disease Drug Pipeline and OLC Development Plans

Unicycive Therapeutics Inc. has released a corporate presentation outlining its progress in developing novel treatments for kidney disease. The company's lead asset, oxylanthanum carbonate (OLC), is being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Unicycive plans to resubmit the New Drug Application (NDA) for OLC by the end of the year, following a recent FDA meeting that addressed a manufacturing-related deficiency. No other concerns were identified by the FDA regarding the clinical or safety data submitted. If approved, OLC would offer a smaller, swallowable tablet as compared to the reference drug Fosrenol, aiming to address the significant issue of pill burden among patients. The company reports a cash runway into 2027 to support the NDA resubmission, potential approval, and commercial launch of OLC. Additional pipeline programs include UNI-494 for acute kidney injury and chronic kidney disease. You can access the full presentation through the link below.

Disclaimer: This news brief was created by Public Technologies (PUBT) 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. Unicycive Therapeutics Inc. published the original content used to generate this news brief on October 29, 2025, and is solely responsible for the information contained therein.

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The company's lead asset, oxylanthanum carbonate (OLC), is being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. Unicycive plans to resubmit the New Drug Application (NDA) for OLC by the end of the year, following a recent FDA meeting that addressed a manufacturing-related deficiency. No other concerns were identified by the FDA regarding the clinical or safety data submitted. If approved, OLC would offer a smaller, swallowable tablet as compared to the reference drug Fosrenol, aiming to address the significant issue of pill burden among patients. The company reports a cash runway into 2027 to support the NDA resubmission, potential approval, and commercial launch of OLC. Additional pipeline programs include UNI-494 for acute kidney injury and chronic kidney disease. 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Unicycive Therapeutics Inc. published the original content used to generate this news brief on October 29, 2025, and is solely responsible for the information contained therein.</span></em>\n</div></body></html>\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"UNCY","symbol_name":"Unicycive Therapeutics, Inc.","start_time":0,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20251029:nNDL4sF7s1:1","article_id":"2579600139","we_media_id":"1032215980","thumbnails":[],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2579600139","pubTimestamp":1761770372,"columns":[],"sourceInfo":null,"weMediaInfo":{"media_name":"Reuters","introduction":"Reuters.com brings you the latest news from around the world, covering breaking news in markets, business, politics, entertainment and technology","home_visible":1,"id":"1032215980","head_image":"https://community-static.tradeup.com/news/4567337cbdf294b657b1fa87c5488b48"},"summary":"Unicycive Therapeutics Inc. has released a corporate presentation outlining its progress in developing 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. Unicycive plans to resubmit the New Drug Application  for OLC by the end of the year, following a recent FDA meeting that addressed a manufacturing-related deficiency. No other concerns were identified by the FDA regarding the clinical or safety data submitted. If approved, OLC would offer a smaller, swallowable tablet as compared to the reference drug Fosrenol, aiming to address the significant issue of pill burden among patients. The company reports a cash runway into 2027 to support the NDA resubmission, potential approval, and commercial launch of OLC. Additional pipeline programs include UNI-494 for acute kidney injury and chronic kidney disease. 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