Unicycive Therapeutics, Inc. Common StockUNCY
Scheduled
Unicycive Therapeutics, Inc. Common Stock H.C. Wainwright 28th Annual Global Investment Conference
Review the key takeaways and the transcript of this earnings call.
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Key takeaways
- Oxylanthine carbonate (OLC) is pursuing a 505(b)(2) pathway with composition of matter exclusivity until 2031.
- Approximately 450,000 patients on dialysis need phosphate management, and management identified pill burden and associated adverse events as major adherence challenges.
- In the most recent clinical trial, approximately 69% of patients achieved control with a 500 milligram tablet taken three times a day, targeting a serum phosphate level of 5.5 milligram per deciliter or below.
- The FDA issued a second CRL on June 30th of this year, tied entirely to previously identified third-party manufacturing deficiencies, with no concerns regarding the molecule's clinical efficacy or safety and no request for additional data.
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