Submit a New Drug Application for Renazorb
Not 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
- 29 Nov 2021
- Due
- 31 Dec 2022
- Checked
- 1 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“confirm our previous guidance to submit an NDA for Renazorb in the fourth quarter of 2022”
What we found
Evidence strength A What the grades mean
The company did not submit the Renazorb NDA by the end of 2022; subsequent filings indicate the FDA recommended an additional tolerability study before the NDA could be filed.
-
A Unicycive Therapeutics, Inc. 10-K filed 2024-03-28
“After reviewing the data, the Agency recommend that we conduct a tolerability study of Oxylanthanum Carbonate in chronic kidney disease patients on dialysis before filing the NDA.” ✓ confirmed on the page
Market reaction: the shares moved -4.7% against the S&P 500 over the three sessions around the disclosure (27 Mar 2024 to 2 Apr 2024). What this measures
Checked 1 Oct 2026.
Commitment lineage
Every time the company restated this commitment. The original is never changed, and the outcome is always measured against version 1.
- 1 versions
-
Version 1 · original · stated 29 Nov 2021
Deadline 31 Dec 2022 (“in the fourth quarter of 2022”)
-
Version 2 · stated 31 Mar 2022
Deadline 30 Jun 2022 (“mid-2022”) · wording expected
“support an Investigational New Drug submission expected in mid-2022”
-
Version 3 · stated 15 Aug 2022
Deadline 31 Dec 2023 (“in 2023”)
“to file a New Drug Application (NDA) in 2023”
-
Version 4 · stated 14 Nov 2022
Deadline 31 Dec 2023 (“in 2023”) · wording firm
“We remain on track to file a New Drug Application (NDA) in 2023”
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Version 5 · stated 28 Dec 2022
Deadline 30 Jun 2023 (“mid-2023”) · wording firm
“On track to file New Drug Application mid-2023”
-
Version 6 · stated 25 Jun 2024
Deadline 30 Sep 2024 (“Q3 2024”) · wording expected
“New Drug Application (NDA) Submission Anticipated in Q3 2024”
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
- Submit
- Deliverable
- New Drug Application for Renazorb
- In the company’s control
- Medium
- Specificity
- High
- Depends on
- Regulatory
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.
- Third check on a negative finding: agreesBecause a negative finding could harm a company if wrong, a stronger model re-read the evidence fully blind 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-2021-UNCY-002764 · Corrections policy