---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-243074"
form_type: "8-K"
ticker: "MNKD"
cik: "0000899460"
company_name: "MANNKIND CORP"
filed_at: "2026-05-28T12:37:11+00:00"
generated_at: "2026-05-28T13:08:52.407084+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# FDA releases MannKind from Afrezza malignancy study; sBLA for children PDUFA May 29

## Summary
- FDA informed MannKind on May 27, 2026 it is released from postmarketing requirement to assess pulmonary malignancy risk in 8,000-10,000 patients.
- Only remaining postmarketing requirement for Afrezza is pediatric safety/efficacy; sBLA for ages 4-17 has PDUFA target action date May 29, 2026.
- INHALE-1st study for youth (10-17) with type 1 diabetes activated eight additional sites; expects up to 100 participants across 10 sites.
- Primary endpoint of INHALE-1st: percentage with CGM time in range ≥70% at 13 weeks; data expected late 2027.

## SEC filing metadata
- accession: 0001193125-26-243074
- form_type: 8-K
- ticker: MNKD
- cik: 0000899460
- company_name: MANNKIND CORP
- filed_at: 2026-05-28T12:37:11+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/899460/000119312526243074/0001193125-26-243074-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/899460/000119312526243074/mnkd-20260527.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-243074
- JSON: https://secwatch.observer/filing/0001193125-26-243074.json
- Plain text: https://secwatch.observer/filing/0001193125-26-243074.txt

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