Resubmit the Biologics License Application for pz-cel
Delivered by the deadline
AI-assessed · human review in progress Found and assessed by AI from the cited sources. Shown with its evidence; it is not counted in any Kept Score until confirmed.
- Announced
- 12 Aug 2024
- Due
- 31 Dec 2024
- Delivered
- October 2024
- Deadline
- Met
- Late
- Not met
- Today
What the company said
“Abeona continues to expect to resubmit the BLA in the second half of 2024.”
What we found
Evidence strength A What the grades mean
Abeona Therapeutics successfully resubmitted its Biologics License Application for pz-cel in October 2024, which falls within the second half of 2024 deadline.
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A Abeona Therapeutics Inc. 10-K filed 2025-03-20
“In August 2024, we completed a Type A Meeting with the FDA to discuss our forthcoming resubmission of our BLA and in October 2024, we resubmitted our BLA.” ✓ confirmed on the page
Market reaction: the shares moved -3.1% against the S&P 500 over the three sessions around the disclosure (19 Mar 2025 to 24 Mar 2025). What this measures
Checked 2 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
- Resubmit
- Deliverable
- BLA resubmission for pz-cel
- Language
- Expected (“expects”, “plans”)
- In the company’s control
- High
- Specificity
- High
- Conditional
- Yes: validation of sterility and identity assays currently ongoing
- 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.
Not yet confirmed. Shown on the record, but it will not count in any score until it is confirmed. How verification works
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Report an error in this entry Reference: KI-C-2024-ABEO-003398 · Corrections policy