Submit a New Drug Application for ruxolitinib cream
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
- 4 Aug 2020
- Due
- 31 Dec 2020
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“the NDA submission is expected at the end of 2020.”
What we found
Evidence strength A What the grades mean
The FY2020 10-K and a February 2021 8-K both state the atopic dermatitis NDA for ruxolitinib cream was submitted in December 2020 or late in Q4 2020, before the deadline.
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A Incyte 8-K filed 2021-02-09
“the NDA seeking approval of ruxolitinib cream as a treatment for patients with atopic dermatitis was submitted to the FDA late in the fourth quarter of 2020” ✓ confirmed on the page
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A Incyte 10-K filed 2021-02-09
“In December 2020, we submitted an NDA along with the PRV, seeking approval for ruxolitinib cream as a treatment for patients with AD.” ✓ confirmed on the page
Market reaction: the shares moved -9.3% against the S&P 500 over the three sessions around the disclosure (8 Feb 2021 to 11 Feb 2021). What this measures
Checked 10 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.
- Deadline drift +546 days
- 3 versions
-
Version 1 · original · stated 4 Aug 2020
Deadline 31 Dec 2020 (“at the end of 2020”) · wording expected
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Version 2 · stated 3 Aug 2021
Deadline 31 Mar 2022 (“early 2022”) · wording expected
“QD ruxolitinib is in stability testing with an NDA submission planned for early 2022.”
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Version 3 · stated 2 Nov 2021
Deadline 30 Jun 2022 (“early next year”)
“Once-daily (QD) ruxolitinib is in stability testing and is on track for a new drug application (NDA) submission early next year.”
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
- NDA submission for ruxolitinib cream
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
How this entry was checked
- Commitment recordedThe company's words were matched word for word against the filing.
- First checkAn AI model, Claude (Anthropic), read the company's later filings and recorded the outcome with a quoted passage.
- Second check: agreesA different AI model, Gemini (Google), 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-2020-INCY-005674 · Corrections policy