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在OLC因高磷血症获得第二次RTL后，单胞菌销量暴跌
2026-07-01 02:05
- Unicycive Therapeutics is down ~37% in Tuesday afternoon trading after announcing it has received a Complete Response Letter from the FDA for its resubmitted NDA for oxylanthanum carbonate (OLC) to treat hyperphosphatemia in patients with chronic kidney disease on dialysis.
- The company had received another CRL in June 2025 related to manufacturing issues at a third-party site.
- The problem this time is that the agency was unable to reinspect the site by the action date, which was June 26.
- No additional data has been requested by the FDA.
- In a recent interview with Seeking Alpha, Unicycive CEO Shalabh Gupta explained how OLC would compete in a crowded hyperphosphatemia market.
More on Unicycive Therapeutics
- Unicycive Therapeutics: A Catalyst Play With Real Fundamental Upside
- Unicycive Therapeutics, Inc. (UNCY) Presents at 25th Annual Needham Virtual Healthcare Conference Transcript
- Unicycive seeks to distinguish OLC in crowded CKD hyperphosphatemia market
- Biopharmas look to China, elsewhere for partnerships, R&D
- Seeking Alpha’s Quant Rating on Unicycive Therapeutics
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