---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-018667"
form_type: "8-K"
ticker: "ADMA"
cik: "0001368514"
company_name: "ADMA BIOLOGICS, INC."
filed_at: "2026-05-04T23:59:59+00:00"
generated_at: "2026-05-14T23:51:04.212119+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.78
calibrated_materiality_score: 0.78
confidence: "high"
source: SEC EDGAR
---

# ADMA Biologics receives FDA approval to expand ASCENIV label to pediatric patients 2 years+

## Summary
- FDA approved label expansion for ASCENIV to include pediatric primary humoral immunodeficiency patients aged 2 years and older.
- Previously approved only for patients 12 years and older; approval fulfills post-marketing pediatric assessment commitment.
- CEO Adam Grossman: expanded label allows addressing treatment needs of younger PI patients earlier in their treatment journey.
- COO Kaitlin Kestenberg highlighted collaboration with PI community and families; approval reflects strong clinical execution.

## SEC filing metadata
- accession: 0001140361-26-018667
- form_type: 8-K
- ticker: ADMA
- cik: 0001368514
- company_name: ADMA BIOLOGICS, INC.
- filed_at: 2026-05-04T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.78
- calibrated_materiality_score: 0.78
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1368514/000114036126018667/0001140361-26-018667-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1368514/000114036126018667/ef20072196_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-018667
- JSON: https://secwatch.observer/filing/0001140361-26-018667.json
- Plain text: https://secwatch.observer/filing/0001140361-26-018667.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.