Resubmit the New Drug Application for Oxylanthanum Carbonate
Delivered by the deadline
AI-confirmed · human review in progress Independent AI checks agreed on primary SEC or regulator evidence. Records are now being reviewed by hand, starting with those our customers order.
- Announced
- 28 Oct 2025
- Due
- 31 Dec 2025
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“the Company plans to resubmit the NDA for OLC by year-end.”
What we found
Evidence strength A What the grades mean
The company successfully resubmitted the New Drug Application for Oxylanthanum Carbonate, as evidenced by the FDA's active review and established PDUFA target date of June 29, 2026, reported in March 2026.
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A Unicycive Therapeutics, Inc. 8-K filed 2026-03-30
“Oxylanthanum carbonate (OLC) New Drug Application (NDA) resubmission under review by U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) target action date of June 29, 2026” ✓ confirmed on the page
Market reaction: the shares moved +8.1% against the S&P 500 over the three sessions around the disclosure (27 Mar 2026 to 1 Apr 2026). What this measures
Checked 1 Oct 2026.
Commitment DNA
The structured record of this commitment. Fields the company did not state are left blank rather than guessed.
- Event type
- Regulatory submission
- Indicative materiality
- High rules
- Action
- Resubmit
- Deliverable
- New Drug Application for Oxylanthanum Carbonate
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- Medium
- Specificity
- High
- Conditional
- Yes: resolution of the single deficiency identified in the CRL related to the compliance status of a third-party manufacturing vendor
- Depends on
- Regulatory, Supplier
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Gemini (Google), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Claude (Anthropic), re-read the evidence without being told the outcome and reached the same answer.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
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Report an error in this entry Reference: KI-C-2025-UNCY-002811 · Corrections policy