secwatch.observer — SEC 8-K summary
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Issuer:     ABEONA THERAPEUTICS INC. (ABEO)
CIK:        0000318306
Form:       8-K
Filed at:   2024-11-14T23:59:59+00:00
Accession:  0001493152-24-045338
Event type: earnings
Sentiment:  neutral
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Abeona Q3 net loss $30.3M; FDA sets pz-cel PDUFA Apr 29, 2025
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- Net loss Q3 2024: $30.3M vs $11.8M YoY; includes $15.2M warrant revaluation loss.
- Cash, equivalents and investments $110.0M; down $13M from Q2; cash runway into 2026.
- FDA accepted pz-cel BLA resubmission; PDUFA target action date April 29, 2025.
- CMS granted pz-cel product-specific code and Pre-MDC MS-DRG 018 reimbursement.
- New U.S. patent issued for pz-cel (exp. 2037); lease for added manufacturing capacity.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/318306/000149315224045338/0001493152-24-045338-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/318306/000149315224045338/form8-k.htm
  HTML page:      https://secwatch.observer/filing/0001493152-24-045338

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer