secwatch.observer — SEC 8-K summary
======================================

Issuer:     Ocugen, Inc. (OCGN)
CIK:        0001372299
Form:       8-K
Filed at:   2024-08-05T23:59:59+00:00
Accession:  0001104659-24-085603
Event type: regulatory
Sentiment:  positive
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Ocugen gets FDA nod to begin expanded access program for OCU400 in retinitis pigmentosa
--------------------------------------------------------------------------------

- FDA approved expanded access program for OCU400 for adult RP patients 18+ with minimal retinal preservation.
- OCU400 is a modifier gene therapy; positive Phase 1/2 data and ongoing Phase 3 liMeliGhT trial.
- RP affects ~300,000 in US/Europe, 1.6M globally; EAP provides access before BLA approval.
- Targets BLA and MAA approval in 2026; OCU400 has orphan drug and RMAT designations from FDA.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1372299/000110465924085603/0001104659-24-085603-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1372299/000110465924085603/tm2420843d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-24-085603

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