Unicycive says it has responded to all FDA information requests

Unicycive says it has responded to all FDA information requests

Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company focused on developing therapies for kidney diseases, has announced an update on its New Drug Application (NDA) for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The company has responded to all information requests from the U.S. Food and Drug Administration (FDA) and expects a final decision by the PDUFA action date of June 28, 2025 [1].

The FDA identified deficiencies in cGMP compliance at a third-party manufacturing vendor following an inspection. Despite these issues, Unicycive remains confident in the promise of OLC based on extensive clinical and preclinical data. The company is actively discussing with its partners to resolve the FDA's concerns and is eager to bring OLC to market as soon as possible.

OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency. It aims to reduce the number and size of pills required to treat hyperphosphatemia, potentially offering better patient adherence compared to current treatment options. The NDA submission package includes data from three clinical studies, multiple preclinical studies, and chemistry, manufacturing, and controls (CMC) data [1].

Unicycive's stock has shown strong momentum, with analysts initiating coverage and assigning a Buy rating. Lucid Capital Markets, for instance, has given Unicycive a Buy rating with a price target of $12, highlighting the potential launch of OLC in the second half of 2025 as a key factor for the positive outlook [2][3]. The company is also advancing UNI-494, a pro-drug of Nicorandil, for acute kidney injury and chronic kidney disease, which has undergone Phase 1 safety testing in the United Kingdom.

Unicycive has raised up to $180 million from prominent institutions over the past 15 months and maintains a healthy current ratio of 1.64. The company's comprehensive drug portfolio for kidney diseases and innovative treatment approach offer significant potential for growth.

References:
[1] https://www.tradingview.com/news/reuters.com,2025-06-10:newsml_GNXSJW8K:0-unicycive-provides-update-on-new-drug-application-for-oxylanthanum-carbonate-to-treat-hyperphosphatemia-in-patients-with-chronic-kidney-disease-on-dialysis/
[2] https://www.gurufocus.com/news/2906822/unicycive-therapeutics-uncy-receives-buy-rating-with-promising-future-uncy-stock-news
[3] https://www.investing.com/news/analyst-ratings/lucid-capital-markets-initiates-buy-rating-on-unicycive-stock-93CH-4080146