H.C. Wainwright & Co. analysts Ed Arce and Thomas Yip, in a research report published on June 25, 2025, provided an update on Unicycive Therapeutics Inc. (UNCY:NASDAQ) following the company's announcement of positive results from its UNI-OLC-201 pivotal trial of oxylanthanum carbonate (OLC) for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients. The analysts reaffirmed their Buy rating and US$4.50 price target on the stock.
"We are highly confident that OLC data to date represent an approvable package," Arce and Yip stated. The analysts highlighted the positive safety and tolerability profile of OLC at clinically effective doses in CKD patients on dialysis.
Key findings from the trial include:
1. Low discontinuation rate: In the Evaluable Population (n=71), only 1 patient (1.4%) discontinued due to a treatment-related adverse event (AE). In the Safety Population (n=86), 3 treatment-related discontinuations occurred (3.5%).
2. Favorable safety profile: GI-related AEs were most common, with diarrhea and vomiting at 9% and 6%, respectively. No treatment-related serious adverse events (SAEs) were reported.
3. Promising efficacy signals: Although not designed to evaluate efficacy, 90% of patients (77 out of 86) achieved phosphate levels ≤5.5 mg/dL at the end of titration with OLC.
The analysts noted, "Overall, management believes OLC's low discontinuation rate compares favorably to the 14% discontinuation rate for Fosrenol (lanthanum carbonate), per its FDA-approved package insert."
Unicycive's strategic plans include preparing for a U.S. commercial launch, with a focus on reimbursement and distribution. The company is on track to file a New Drug Application (NDA) for OLC in the third quarter of 2024, setting the stage for potential approval and market entry by mid-2025.
Arce and Yip emphasized the potential advantages of OLC, stating, "Along with the significantly lower pill burden compared to other phosphate binders, we believe the superior tolerability may be attributable to OLC's nanoparticle technology."
The analysts' US$4.50 price target suggests significant upside potential from the share price at the time of the report of US$0.68.
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Disclosures for H.C. Wainwright & Co., Unicycive Therapeutics Inc., June 25, 2024
This material is confidential and intended for use by Institutional Accounts as defined in FINRA Rule 4512(c). It may also be privileged or otherwise protected by work product immunity or other legal rules. If you have received it by mistake, please let us know by e-mail reply to [email protected] and delete it from your system; you may not copy this message or disclose its contents to anyone. The integrity and security of this message cannot be guaranteed on the Internet. H.C. WAINWRIGHT & CO, LLC RATING SYSTEM: H.C. Wainwright employs a three tier rating system for evaluating both the potential return and risk associated with owning common equity shares of rated firms. The expected return of any given equity is measured on a RELATIVE basis of other companies in the same sector. The price objective is calculated to estimate the potential movements in price that a given equity could reach provided certain targets are met over a defined time horizon. Price objectives are subject to external factors including industry events and market volatility.
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Ed Arce and Thomas Yip , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies. None of the research analysts or the research analyst’s household has a financial interest in the securities of Unicycive Therapeutics, Inc. (including, without limitation, any option, right, warrant, future, long or short position). As of May 31, 2024 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Unicycive Therapeutics, Inc..
Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report. The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The Firm or its affiliates did not receive compensation from Unicycive Therapeutics, Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Unicycive Therapeutics, Inc. as of the date of this research report.
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