Thursday, May 15, 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.
Counting Down To The OLC PDUFA Date. Unicycive reported a 1Q25 loss of $21.2 million or $(0.61) per share, consistent with our estimates. We continue to expect approval of OLC (oxylanthanum carbonate) around its PDUFA date of June 28, followed by its launch later in the year. The company had $19.8 million in cash on March 31, 2025.
OLC Reduces Pill Burden To Improve Compliance. OLC is Unicycive proprietary formulation of lanthanum carbonate. It was developed to reduce serum phosphate levels in renal dialysis patients with only two small pills per day. We expect OLC to compete against Fosrenol (from Shire), the approved formulation of lanthanum, that requires chewing 3 to 6 large pills each day. This difference makes patient compliance easier.
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