Analyst Ed Arce of H.C. Wainwright maintained a Buy rating on Unicycive Therapeutics (UNCY – Research Report), with a price target of $4.50.
Ed Arce’s Buy rating for Unicycive Therapeutics is influenced by several promising developments within the company’s pipeline. Unicycive’s lead program, oxylanthanum carbonate (OLC), is geared towards treating hyperphosphatemia in patients with chronic kidney disease on dialysis. The company is currently in the midst of a pivotal trial that is expected to yield top-line results in the second quarter of 2024. Given that the efficacy of OLC has already been established in a completed bioequivalence study, a positive outcome from the current trial could lead to a New Drug Application submission by mid-2024. This aligns with Unicycive’s financial runway, which is projected to extend into the second half of 2024, and supports Arce’s expectation for FDA approval by mid-2025. The entry into the significant hyperphosphatemia market post-approval forms a foundational reason for the Buy rating.
Furthermore, Arce’s valuation incorporates the potential of Unicycive’s second clinical program, UNI-494, which is expected to complete Phase 1 studies in 2024. UNI-494, designed to improve upon the pharmacokinetics and safety profile of nicorandil, could address acute kidney injury, thereby expanding Unicycive’s market reach. Arce’s $4.50 price target is based on a risk-adjusted net present value model, accounting for projected royalties from the sales of OLC and UNI-494 in the U.S. and EU markets. The model reflects a 15% discount rate to consider the development risks and conservatively assumes no terminal value post-market exclusivity period. However, Arce also cautions investors about potential risks, including regulatory hurdles, partnership challenges, and funding shortfalls that could impact the investment thesis and target price.
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Unicycive Therapeutics (UNCY) Company Description:
Unicycive Therapeutics Inc is a biotechnology company dedicated towards developing treatments for certain medical conditions. It is focusing on kidney diseases. The company’s lead drug, Renazorb, is a novel phosphate binding agent being developed for the treatment of hyperphosphatemia. Unicycive’s other drug, UNI-494, is a new chemical entity with issued composition of matter patent protection in late preclinical development for the treatment of acute kidney injury.
Read More on UNCY:
- Unicycive Therapeutics Issues Shareholder Letter to Highlight Corporate Progress and Key Upcoming Milestones
- Unicycive Therapeutics enrolls first patient in trial for OLC in CKD
- Unicycive Therapeutics Announces Enrollment of First Patient in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC) in Patients with Chronic Kidney Disease on Dialysis
- Unicycive Therapeutics to Participate in Two Investor Conferences in December 2023
