Submit a Biologics License Application for lenzilumab
Not 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
- 31 Dec 2021
- Checked
- 25 Oct 2026
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“BLA submission”
What we found
Evidence strength A What the grades mean
The company did not submit a Biologics License Application (BLA) for lenzilumab to the FDA by the end of 2021, focusing instead on an Emergency Use Authorization (EUA) request which the FDA declined.
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A Humanigen, Inc. 10-K filed 2022-03-01
“We also submitted an application for marketing authorization of lenzilumab in hospitalized COVID-19 patients to Medicines and Healthcare products Regulatory Agency (“MHRA”) of the United Kingdom” ✓ confirmed on the page
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A Humanigen, Inc. 10-Q filed 2022-05-05
“On September 8, 2021, FDA informed us that it had declined to issue an EUA for lenzilumab in this indication.” ✓ confirmed on the page
Checked 25 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
- BLA submission
- In the company’s control
- Medium
- 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.
- Third check on a negative finding: agreesBecause a negative finding could harm a company if wrong, a stronger model re-read the evidence fully blind and reached the same answer.
Confirmed. This outcome counts towards the company's Kept Score. How verification works
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