---
schema_version: "secwatch.filing_event.v1"
accession: "0001564590-21-061212"
form_type: "8-K"
ticker: "MNKD"
cik: "0000899460"
company_name: "MANNKIND CORP"
filed_at: "2021-12-27T23:59:59+00:00"
generated_at: "2026-06-27T22:27:40.730999+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "medium"
source: SEC EDGAR
---

# United Therapeutics resubmits Tyvaso DPI NDA to FDA after CRL

## Summary
- UT received a Complete Response Letter from FDA on Oct 18, 2021 for Tyvaso DPI.
- UT disclosed on Dec 27, 2021 that it has resubmitted the NDA to FDA.
- Tyvaso DPI uses MannKind's Inhalation technology; resubmission is a key regulatory milestone.

## SEC filing metadata
- accession: 0001564590-21-061212
- form_type: 8-K
- ticker: MNKD
- cik: 0000899460
- company_name: MANNKIND CORP
- filed_at: 2021-12-27T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: medium
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/899460/000156459021061212/0001564590-21-061212-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/899460/000156459021061212/mnkd-8k_20211227.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001564590-21-061212
- JSON: https://secwatch.observer/filing/0001564590-21-061212.json
- Plain text: https://secwatch.observer/filing/0001564590-21-061212.txt

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