Submit NDA for ruxolitinib cream in atopic dermatitis to regulators

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: 13 Feb 2020
Due: 31 Dec 2020

Deadline
Met
Late
Not met
Today

What the company said

“The NDA submission, seeking approval of ruxolitinib cream in atopic dermatitis, is expected in the fourth quarter of 2020 following long-term safety and efficacy data from both pivotal trials.”

SourceIncyte Form 8-K press release, 2020-02-13
FilingSEC filing index
Deadline as statedin the fourth quarter of 2020
Deadline used31 Dec 2020, the last day of the stated period
TypeRegulatory
Permanent referenceKI-C-2020-INCY-005668
Cite as https://keptindex.org/c/KI-C-2020-INCY-005668/ — this address never changes.

What we found

Evidence strength A What the grades mean

An 8-K filed 2021-02-09 says the atopic dermatitis NDA was submitted to the FDA late in Q4 2020, within the stated quarter.

A
Incyte 8-K filed 2021-02-09 Regulatory filing · published 9 Feb 2021 · retrieved 10 Oct 2026 · kept permanently by the SEC
“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, including use of the previously acquired priority review voucher (PRV).” ✓ 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.

2 versions

Version 1 · original · stated 13 Feb 2020

Deadline 31 Dec 2020 (“in the fourth quarter of 2020”) · wording expected
Version 2 · stated 5 May 2020

Deadline 31 Dec 2020 (“at the end of 2020”) · wording firm

“we are also on track to submit the NDA for ruxolitinib cream at the end of 2020”
Source for this version

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 for ruxolitinib cream in atopic dermatitis
Where: US
Language: Expected (“expects”, “plans”)
In the company’s control: High
Specificity: High
Conditional: Yes: following long-term safety and efficacy data from both pivotal trials

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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