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 on Unicycive Therapeutics is primarily driven by a number of significant developments. Firstly, Unicycive Therapeutics has successfully secured an agreement with the FDA on the regulatory pathway for Oxylanthanum Carbonate (OLC), a drug developed for treating hyperphosphatemia in patients with chronic kidney disease on dialysis. This agreement was reached in a recent Type C meeting with the FDA and covers the structure of a new pivotal trial. The trial, which is likely to enroll around 60 patients for a four-week OLC treatment after titration to effective doses, is largely as previously expected.
Secondly, Arce is optimistic about the primary goal of this study, which is to assess OLC’s tolerability and the rate of treatment discontinuation. Importantly, no statistical analysis to measure OLC’s efficacy is included in the study, suggesting FDA’s confidence in the drug. Furthermore, the FDA has not asked for additional studies, indicating that the results from this pivotal trial along with safety data from preclinical studies and efficacy data from the bioequivalence study would suffice for OLC’s NDA submission. Unicycive has also secured an agreement with the FDA on all components of the NDA package. With these developments and OLC’s demonstrated safety and tolerability, Arce anticipates no major obstacles to OLC’s U.S. approval.
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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 Reaches Alignment with the FDA on Path to File New Drug Application for Oxylanthanum Carbonate (OLC)
- Unicycive Therapeutics appoints Sara Kenkare-Mitra to board of directors
- Unicycive Therapeutics Strengthens Board of Directors with Appointment of Sara Kenkare-Mitra, PhD
- Unicycive Therapeutics Featured on Nasdaq Amplify Issuer Spotlight Series
