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

Issuer:     Outlook Therapeutics, Inc. (OTLK)
CIK:        0001649989
Form:       8-K
Filed at:   2025-11-13T23:59:59+00:00
Accession:  0001104659-25-111316
Event type: regulatory
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA accepts Outlook Therapeutics' BLA resubmission for ONS-5010; PDUFA date Dec 31, 2025
--------------------------------------------------------------------------------

- FDA acknowledged receipt of BLA resubmission for ONS-5010 (bevacizumab-vikg) and assigned Class 1 review.
- Class 1 review results in a two-month review period from resubmission date.
- PDUFA goal date set for December 31, 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1649989/000110465925111316/0001104659-25-111316-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1649989/000110465925111316/tm2531109d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-111316

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