Submit a new drug application for parsaclisib in relapsed or refractory lymphoma to the FDA
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
- 9 Feb 2021
- Due
- 31 Dec 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Data from the CITADEL program are expected to form the basis of an NDA seeking FDA approval of parsaclisib, which is expected to be submitted in the second half of 2021.”
What we found
Evidence strength A What the grades mean
A 10-K filing reports FDA acceptance of a parsaclisib NDA in October 2021, implying submission before the deadline. The NDA was later withdrawn in January 2022.
-
A Incyte 8-K filed 2022-02-08
“In January, Incyte announced the withdrawal of the New Drug Application (NDA) in the United States for parsaclisib” ✓ confirmed on the page
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A Incyte 10-K filed 2022-02-08
“In October 2021, we announced the FDA acceptance of a NDA seeking approval of parsaclisib for the treatment of patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma and mantle cell lymphoma.” ✓ confirmed on the page
Market reaction: the shares moved -9.2% against the S&P 500 over the three sessions around the disclosure (7 Feb 2022 to 10 Feb 2022). What this measures
Checked 10 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
- NDA submission for parsaclisib to the FDA
- Where
- United States
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- Medium
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-2021-INCY-005680 · Corrections policy