Sponsor describes a nanoparticle oral phosphate binder and a March 25, 2027 target after NDA resubmission.
- Published
- Oct 21, 2026
- Retrieved
- 2026-10-30 02:09:48 UTC
Rx-UNCY-2703 · March 25, 2027 sponsor target
Will the FDA approve Oxylanthanum carbonate for hyperphosphatemia in chronic kidney disease patients on dialysis?
Sponsor describes a nanoparticle oral phosphate binder and a March 25, 2027 target after NDA resubmission.
Open outcome workspaceA PDUFA goal date is not an approval determination or a trading cutoff. Application scope, delays and invalid-result terms require reviewed rules.
2 publications1 exact-program1 related2 context / correction notes
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Sponsor describes a nanoparticle oral phosphate binder and a March 25, 2027 target after NDA resubmission.
Registry identifies an OLC tolerability study in dialysis patients sponsored by Unicycive.
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These terms require review and cannot resolve a market.
RESEARCH DRAFT / NOT FINAL RULES / NOT COMMITTED Program: Oxylanthanum carbonate Sponsor: Unicycive Therapeutics Indication under review: hyperphosphatemia in chronic kidney disease patients on dialysis Event: FDA marketing-approval decision Sponsor target: 2027-03-25 (date only, not a trading cutoff) YES: FDA approval of the exact application, formulation and eligible indication, established under a reviewed evidence hierarchy. Exact application/label scope requires review. NO: The approved market terms must specify treatment of a Complete Response Letter, withdrawal, extension and no decision by cutoff. No automatic NO outcome is inferred from the sponsor target date. INVALID: The approved terms must specify erroneous dates, ambiguous identity, unsupported evidence and withdrawal handling. No policy has been committed for this candidate. Cutoff and timezone: UNSET / OWNER APPROVAL REQUIRED. Evidence: FDA approval letter or other authoritative FDA record; sponsor disclosures require the corroboration specified in final rules. Oracle: assertion, dispute bond, liveness and final settlement require separately reviewed deployment settings. This draft cannot resolve a market or pay a claim. Publish reviewed canonical bytes and their keccak256 commitment before listing.
No question ID, approved deadline or UMA assertion exists for this research candidate. Sandbox claims have no redemption rights.