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

Issuer:     Outlook Therapeutics, Inc. (OTLK)
CIK:        0001649989
Form:       8-K
Filed at:   2025-04-08T23:59:59+00:00
Accession:  0001558370-25-004606
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA accepts resubmission of OTLK's BLA for ONS-5010; PDUFA date set for August 27, 2025
--------------------------------------------------------------------------------

- FDA acknowledged receipt of resubmission of BLA for ONS-5010 (bevacizumab-vikg).
- FDA designated the BLA as a Class 2 review with a six-month review period.
- PDUFA goal date for the BLA is August 27, 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1649989/000155837025004606/0001558370-25-004606-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1649989/000155837025004606/otlk-20250408x8k.htm
  HTML page:      https://secwatch.observer/filing/0001558370-25-004606

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