Submit the OLC New Drug Application to the FDA
Delivered after the deadline (3 days after the deadline)
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 14 Aug 2024
- Due
- 31 Aug 2024
- Delivered
- 3 Sep 2024
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“We remain on track to submit our NDA by the end of August 2024”
What we found
Evidence strength A What the grades mean
The company committed to submitting the NDA by the end of August 2024, but filings confirm the submission occurred on September 3, 2024.
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A Unicycive Therapeutics, Inc. 10-Q filed 2024-11-13
“On September 3, 2024, we submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Oxylanthanum Carbonate (OLC)” ✓ confirmed on the page
Market reaction: the shares moved -3.1% against the S&P 500 over the three sessions around the disclosure (12 Nov 2024 to 15 Nov 2024). 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
- Submit
- Deliverable
- OLC New Drug Application
- Language
- Firm (“will”, “on track to”)
- In the company’s control
- High
- 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.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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Report an error in this entry Reference: KI-C-2024-UNCY-002804 · Corrections policy