Unicycive Therapeutics Announces Resubmission of New Drug Application for Oxylanthanum Carbonate
Unicycive Therapeutics resubmitted its NDA for oxylanthanum carbonate (OLC), an investigational oral phosphate binder for hyperphosphatemia in dialysis patients, with CMC data from a new manufacturing vendor. The FDA did not raise clinical efficacy or safety concerns in prior CRLs; the resubmission includes 12 months of stability data and in-vitro bridging data, and the new vendor's facility received a 'No Action Indicated' FDA inspection in March 2024. Acceptance is anticipated within 30 days with a new PDUFA date roughly six months from resubmission.
Key figures
- Drug Name
- oxylanthanum carbonate (OLC)
- Cash runway
- into 2H 2027
- Cash position
- $61.4 million
- Pdufa timeline
- expected 6 months from resubmission
- Patent exclusivity
- until 2031, potential extension to 2035
- Stability data months
- 12
- Nda acceptance expected
- within 30 days
AI analysis
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