Thursday, November 13, 2025
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
3Q25 Reported With OLC Update. Unicycive reported a 3Q25 loss of $6.0 million or $(0.33) per share, below our expectations of $(8.4) million. Importantly, the company confirmed previous plans to resubmit its NDA for OLC (oxylanthanum citrate) by the end of the year, implying a new PDUFA date during 1H26. Cash at the end of the quarter was $42.7 million.
OLC Resubmission Planned Before Year-End. Unicycive previously announced that it held a meeting with the FDA to discuss the issue with a third-party manufacturer cited as a deficiency in the Complete Response Letter (CRL) received in June 2025. After the FDA meeting and an inspection of the third-party manufacturer by EU regulators, the company plans to resubmit the NDA. Assuming a PDUFA (Prescription Drug User Fee Act) review time of 6 months, an answer could be received during 1H26.
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