Submit a Biologics License Application for EB-101 to the FDA

Delivered after the deadline (87 days after 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: 3 Nov 2022
Due: 30 Jun 2023
Delivered: 25 Sep 2023

Deadline
Met
Late
Not met
Today

What the company said

“Abeona intends to submit a Biologics License Application (BLA) for EB-101 to the U.S. Food and Drug Administration (FDA) in the second quarter of 2023.”

SourceAbeona Therapeutics Inc. Form 8-K press release, 2022-11-03
FilingSEC filing index
Deadline as statedin the second quarter of 2023
Deadline used30 Jun 2023, the last day of the stated period
TypeRegulatory
Permanent referenceKI-C-2022-ABEO-003388
Cite as https://keptindex.org/c/KI-C-2022-ABEO-003388/ — this address never changes.

What we found

Evidence strength A What the grades mean

The company originally intended to submit the BLA in the second quarter of 2023, but subsequently delayed the submission to the third quarter, ultimately filing it on September 25, 2023.

A
Abeona Therapeutics Inc. 10-Q filed 2023-08-08 Regulatory filing · published 8 Aug 2023 · retrieved 2 Oct 2026 · kept permanently by the SEC · fingerprint 0640724d17a5
“we intend to submit a Biologics License Application (“BLA”) for EB-101 to the U.S. Food and Drug Administration (“FDA”) in the third quarter of 2023.” ✓ confirmed on the page
A
Abeona Therapeutics Inc. 10-Q filed 2023-11-13 Regulatory filing · published 13 Nov 2023 · retrieved 2 Oct 2026 · kept permanently by the SEC · fingerprint 605693d025c7
“On September 25, 2023, we submitted a Biologics License Application (“BLA”) for EB-101 to the U.S. Food and Drug Administration (“FDA”).” ✓ confirmed on the page

Market reaction: the shares moved +1.4% against the S&P 500 over the three sessions around the disclosure (7 Aug 2023 to 10 Aug 2023). What this measures

Checked 2 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 3 Nov 2022

Deadline 30 Jun 2023 (“in the second quarter of 2023”) · wording aspirational
Version 2 · stated 14 Nov 2022

Deadline 30 Jun 2023 (“in the second quarter of 2023”) · wording expected

“the Company plans to submit a Biologics License Application (BLA) for EB-101 to the U.S. Food and Drug Administration (FDA) in the second quarter of 2023.”
Source for this version
Version 3 · stated 8 Aug 2023

Deadline 30 Sep 2023 (“third quarter of 2023”) · wording expected

“Abeona anticipates submitting the BLA in the third quarter of 2023.”
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: Biologics License Application for EB-101
Where: United States
Language: Aspirational (“aims”, “intends”)
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.

Confirmed. This outcome counts towards the company's Kept Score. How verification works

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