
Tuesday, April 01, 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.
FY2025 Made Significant Progress. Unicycive reported a 4Q loss of $21.7 million or $(0.20) per share and a loss of $37.8 million or $(0.56) per share for FY2024. Cash on December 31, 2024 was $26.1 million. The most significant development, in our opinion, is the June 28, 2025, PFUFA date by which the FDA is required to answer to the Oxylanthanum (OLC) NDA.
OLC Launch is expected in Late 2025. The PDUFA date of June 28, 2025, is the statutory date by which the FDA is required to answer the NDA application. We expect OLC to be approved, based on its clinical trial data showing equivalence to lanthanum (Fosrenol, from Shire) with easier dosing, better patient compliance, and more patients reaching the target range for phosphate levels. An estimated 70% of the renal dialysis patients do not have adequate phosphate control. We believe its lower pill burden and improved patient compliance will lead to better outcomes with fewer morbidity events, leading to a strong market share.
Get the Full Report
Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.
This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).
*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision.