Wednesday, May 13, 2026
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.
First Quarter Operating Loss Was Lower Than Our Estimates. Unicycive reported a 1Q Loss From Operations of $8.0 million, compared with our estimate of $9.9 million. An increase of $8.3 million in the Fair Value of Warrant Liabilities resulted in a Net Comprehensive Loss attributable to common shareholders of $12.8 million, or $(0.54) per share. Importantly, the company confirmed that NDA approval for OLC is on track to meet the June 29 PDUFA date. Cash on March 31, 2026, was $57.1 million.
We Expect OLC Approval By The PDUFA Date. The NDA for OLC (oxylanthanum calcium) was submitted in December and accepted for review in January. We believe the preclinical and clinical sections have already passed FDA review, and previous manufacturing problems associated with a contract manufacturer have been corrected. We expect OLC to receive FDA approval on or before its June 29, 2026, approval date.
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