Submit new drug application for mitapivat in the U.S
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
- 11 Jan 2021
- Due
- 30 Jun 2021
- Delivered
- June 2021
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“submit new drug application (NDA) in the U.S. in the second quarter of 2021”
What we found
Evidence strength A What the grades mean
The company successfully submitted the new drug application for mitapivat to the FDA in June 2021, which falls within the second quarter of 2021.
-
A Agios Pharmaceuticals, Inc. 10-Q filed 2021-11-03
“In June 2021, we submitted an NDA for mitapivat to the FDA for the treatment of adults with PK deficiency in the United States” ✓ confirmed on the page
Market reaction: the shares moved -9.7% against the S&P 500 over the three sessions around the disclosure (2 Nov 2021 to 5 Nov 2021). What this measures
Checked 24 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 for mitapivat
- Where
- U.S.
- 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.
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-AGIO-021566 · Corrections policy